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Showing 20 of 27881 trials
Youth Suicide Prevention: CAMS-BI vs. Safety Planning in a Randomized Trial
NCT07628192
Not yet recruiting
Conditions Suicidal Ideation, Suicide Attempt, Safe...
Phase NA
Enrollment 118
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study outlines a randomized controlled trial evaluating two brief suicide-specific interventions for adolescents aged 12-17 who are hospitalized for suicidal ideation or attempts. Suicide remains a leading cause of death among youth, and many adolescents are discharged from inpatient care without targeted, suicide-focused treatment, contributing to high rates of readmission and ongoing risk. This study seeks to address that gap by comparing the effectiveness of the Collaborative Assessment and Management of Suicidality-Brief Intervention (CAMS-BI) with the Stanley-Brown Safety Planning Intervention (SPI), both delivered as single-session interventions during inpatient hospitalization. Participants (N=118) will be randomly assigned to receive either CAMS-BI or SPI. CAMS-BI is a therapeutic, collaborative framework that focuses on identifying and addressing the underlying psychological drivers of suicidality, while SPI is a structured, practical approach that emphasizes immediate safety through coping strategies, support systems, and means restriction. Following the intervention, participants will be monitored for 90 days post-discharge, with follow-ups at 30, 60, and 90 days. The primary outcome is the rate of psychiatric readmissions and suicide-related emergency department visits within 90 days of discharge. Secondary outcomes include changes in suicidal ideation, measured by the Beck Scale for Suicide Ideation, and caregiver confidence in managing their child's safety. Additional measures include distress levels, hopelessness, treatment satisfaction, and engagement. The study hypothesizes that CAMS-BI will result in lower readmission rates, greater reductions in suicidal ideation, and improved caregiver confidence compared to SPI. Both interventions produce individualized safety or stabilization plans that are shared with patients and caregivers and incorporated into discharge planning to support continuity of care. Safety protocols are emphasized throughout the study, given the high-risk population. Participants receive standard clinical care, crisis resources, and close monitoring, with procedures in place to address any escalation in suicide risk. Data will be collected using secure systems, and confidentiality will be maintained through de-identification and controlled access. Overall, this study aims to determine whether a rapid, inpatient, suicide-focused intervention can improve short-term outcomes for high-risk youth and reduce the likelihood of rehospitalization, ultimately informing scalable approaches to suicide prevention in clinical settings.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Behavioral: CAMS Brief Intervention — CAMS-BI is a brief, structured, suicide-focused psychotherapy delivered during inpatient hospitalization that uses the Suicide Status Form to collaboratively identify and directly target the patient's specific psychological drivers of suicidality (e.g., hopelessness, psychological pain, agitation, and self-hate). It emphasizes a strong therapeutic alliance and shared formulation to reduce suicidal risk and support linkage to ongoing care after discharge.
  • Behavioral: Stanley-Brown Safety Planning Intervention — The Stanley-Brown Safety Planning Intervention (SPI) is a brief, structured, collaborative session in which the adolescent and clinician create a personalized written safety plan to use during future suicidal crises. The plan outlines warning signs, internal coping strategies, social supports, professional resources, and steps for restricting access to lethal means to help reduce immediate risk.

Primary Outcomes

  • Reduction of inpatient psychiatry readmissions for suicide risk following CAMS-Brief Intervention VS Stanley-Brown Planning Intervention (90 days following discharge)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-08-01
Completion: 2027-03-01
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 118 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The Cleveland Clinic
Principal Investigators:
  • Tatiana Falcone, M.D. (PRINCIPAL_INVESTIGATOR) - The Cleveland Clinic
Contact Information
Study Contact:
Christina A Deisz, LISW-S
(440) 225-6193
deiszc@ccf.org
Tatiana Falcone, M.D.
(216) 444-7459
falcont1@ccf.org
Interventions
  • Behavioral: CAMS Brief Intervention — CAMS-BI is a brief, structured, suicide-focused psychotherapy delivered during inpatient hospitalization that uses the Suicide Status Form to collaboratively identify and directly target the patient's specific psychological drivers of suicidality (e.g., hopelessness, psychological pain, agitation, and self-hate). It emphasizes a strong therapeutic alliance and shared formulation to reduce suicidal risk and support linkage to ongoing care after discharge.
  • Behavioral: Stanley-Brown Safety Planning Intervention — The Stanley-Brown Safety Planning Intervention (SPI) is a brief, structured, collaborative session in which the adolescent and clinician create a personalized written safety plan to use during future suicidal crises. The plan outlines warning signs, internal coping strategies, social supports, professional resources, and steps for restricting access to lethal means to help reduce immediate risk.
Study Locations (1 sites)
The Cleveland Clinic, Cleveland, Ohio 44195 United States
Eligibility Criteria
Inclusion Criteria: * Adolescents aged 12-17 years. * Admitted to inpatient psychiatry for suicide attempt or active suicidal ideation. * English-speaking patient and parent/guardian. * Ability to understand and the willingness to sign a written informed assent document with a parent/guardian willing and able to sign a written informed consent. Exclusion Criteria: * Moderate or severe intellectual disability (IQ less than 70 and those patients in special education classes full time). * Schizophrenia or history of any type of psychosis including mood related psychosis and brief reactive psychosis. * In custody of Children's Services.
Baby Swim As an Intervention for Depressive Symptoms and Lacking Attachment During the Postpartum Period
NCT06807801
Recruiting
Conditions Depression - Major Depressive Disorder, ...
Phase NA
Enrollment 100
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
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Study Details Design, interventions, and primary outcomes

About This Study

Mental health issues are very common during and after pregnancy, and studies from around the world indicate that 10-15% of all pregnant and postpartum women experience depression. Risk factors for developing depression include a history of depression, low levels of social support, and stressful life events. The symptoms are the same as for depression during other periods of life, but often include feelings of inadequacy regarding motherhood, along with associated feelings of shame or guilt. Obsessive thoughts directed toward the baby may also be part of the symptomatology. Such thoughts are typically experienced as frightening by the mother but, in the vast majority of cases, do not pose any risk to the child. Maternal depression can also affect a mother's ability to bond with her baby, and difficulties in forming an attachment can, in turn, increase and perpetuate depressive symptoms. In the long term, insecure attachment between mother and child can lead to behavioral problems in the child, such as aggression and avoidance, anxiety and depression in adolescence, negative effects on cognitive development, and trust issues in close relationships. Baby swimming is a structured form of interaction that takes place in 34-degree Celsius water in a calm environment, aiming to teach the baby vital skills while stimulating social, intellectual, and motor development. At least one parent actively participates and is encouraged to perform various exercises. These activities strengthen the bond between the baby and the parent and contribute to making time in the water a safe and enjoyable experience. Previous studies have shown that baby swimming can improve attachment between parent and child. In the present project, the aim is to investigate whether baby swimming can be used as an intervention for depressive symptoms in new mothers and whether this intervention can reduce depressive symptoms while also strengthening the bond between mother and child.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Baby swimming — Participants in the treatment group will be contacted by a researcher and invited to an introductory meeting at the swimming facility, where they will receive information about the baby swimming course from the instructor. The course will take place twice a week for five weeks, totaling 10 sessions of 30 minutes each. During the sessions, mothers will be encouraged to engage in physical contact, maintain eye contact, and respond to their baby's signals. The course will also include water safety exercises.

Primary Outcomes

  • Depressive symptoms (Seven months follow up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-02-01
Completion: 2027-08-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Uppsala University
Contact Information
Study Contact:
Alkistis Skalkidou, PhD, MD
+46 6110000
alkistis.skalkidou@kbh.uu.se
Sara Sylvén, PhD, MD
+46706110451
sara.sylven@neuro.uu.se
Interventions
  • Behavioral: Baby swimming — Participants in the treatment group will be contacted by a researcher and invited to an introductory meeting at the swimming facility, where they will receive information about the baby swimming course from the instructor. The course will take place twice a week for five weeks, totaling 10 sessions of 30 minutes each. During the sessions, mothers will be encouraged to engage in physical contact, maintain eye contact, and respond to their baby's signals. The course will also include water safety exercises.
Study Locations (1 sites)
Uppsala University, Uppsala, Sweden
Eligibility Criteria
Inclusion Criteria: Women who have * given birth at full term * are 18 years or older * have a baby aged 3-7 months at the time of inclusion * exhibit depressive symptoms according to the EPDS scale. Exclusion Criteria: * Multiple pregnancy (twins, triplets) * Known psychotic disorder or bipolar disorder * Inability to communicate adequately in Swedish or English, or inability to read and complete digital questionnaires in Swedish or English.
Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation
NCT06832124
Not yet recruiting
Conditions Suicidal Ideation Active, Depression Dis...
Phase NA
Enrollment 50
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to determine whether modulating default mode network (DMN) alpha connectivity using transcranial alternating current stimulation (tACS) can reduce rumination and, in turn, mitigate feelings of entrapment and suicidal ideation in individuals with active suicidal ideation and depression. The main questions it aims to answer are: 1. Is personalized tACS stimulation of the DMN associated with reduced rumination 24 hours after stimulation? 2. Does a reduction in rumination result in lower feelings of entrapment and suicidal ideation? 3. Does personalized tACS stimulation of the DMN lead to a reduction of DMN alpha connectivity? Researchers will compare active tACS stimulation to sham stimulation to assess whether modulating alpha connectivity has a specific effect on rumination, entrapment, suicidal ideation, and DMN alpha connectivity. Participants will: * Receive either active or sham tACS stimulation during stimulation sessions, but all participants will receive active tACS at least once. * Complete self-report measures of rumination, entrapment, and suicidal ideation before and after stimulation. * Undergo EEG recordings to assess changes in DMN alpha connectivity. This clinical trial will be preceded by a pilot study in healthy participants with an anticipated completion of data collection in August 2025.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Triple

Interventions / Regimen

  • Procedure: Sham alpha-tACS — A sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with in-phase stimulation at parieto-occipital brain areas and anti-phase stimulation in frontal brain areas. The stimulation will involve a 10s ramp-up, followed by an immediate 10s ramp-down (no stimulation afterwards).
  • Procedure: alpha-tACS — Active tACS with a sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with a 10s ramp-up and 10s ramp-down after stimulation. In-phase stimulation will be applied to parieto-occipital brain areas and anti-phase stimulation will be applied to frontal brain areas

Primary Outcomes

  • EEG alpha functional connectivity (phase synchronization) (Pre-stimulation to post-stimulation at visit 2 (up to 1 hour))
  • Response style questionnaire (RSQ-10D) (Visit 2 to visit 3 (24 hours))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-01
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sebastian Olbrich
Principal Investigators:
  • Sebastian Olbrich, Prof. Dr. med. (PRINCIPAL_INVESTIGATOR) - Department of Adult Psychiatry and Psychotherapy, University Hospital of Psychiatry Zurich, University of Zurich, Zurich, Switzerland
Contact Information
Study Contact:
Anna Monn, M.Sc.
0041 58 384 34 82
anna.monn@uzh.ch
Interventions
  • Procedure: Sham alpha-tACS — A sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with in-phase stimulation at parieto-occipital brain areas and anti-phase stimulation in frontal brain areas. The stimulation will involve a 10s ramp-up, followed by an immediate 10s ramp-down (no stimulation afterwards).
  • Procedure: alpha-tACS — Active tACS with a sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with a 10s ramp-up and 10s ramp-down after stimulation. In-phase stimulation will be applied to parieto-occipital brain areas and anti-phase stimulation will be applied to frontal brain areas
Eligibility Criteria
Inclusion Criteria: * Active suicidal ideation defined by a score ≥3 on item #10 of the Montgomery-Asberg Depression Rating Scale (MADRS) and a combined score of ≥2 on items #4 + #5 of the Beck Scale for Suicide Ideation (BSS) * Clinical diagnosis of a mild to severe depressive episode without psychotic symptoms * Voluntary patients at inpatient, outpatient, or day-clinic units of mental health care settings in the greater Zurich area * Aged 18-65 years * Fluent in German * Ability to give written informed consent Exclusion Criteria: * Mental disorders due to known physiological conditions * Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders * Intellectual disabilities * Concurrent vagus nerve stimulation, transcranial magnetic stimulation, electro-convulsive therapy, or treatment with nitrous oxide * Pregnancy or breast-feeding * Chronic migraines * Metal implants or any other factor that - in the investigators' judgment - would unduly affect patient safety or compliance during this study
Exploring Virtual Reality Adventure Training Exergaming
NCT05563805
Recruiting
Conditions Physical Activity, Sedentary Behavior, D...
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.

Design

Study type: Interventional Phases: Allocation: Non Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Device: Virtual Reality-based physical activity intervention — The V-RATE intervention will be delivered through a 360-degree non-mobilized treadmill in a university clinical laboratory for 6-8-weeks (1-2 days/week, 30 minutes/session) totaling 6 sessions. The V-RATE program will be focused on creating a safe and immersive environment supportive of physical activity. The treadmill enables an individual can walk and run at self-paced speed, moving in 360-degrees (i.e., forwards, sideways, and backwards) without risk of falling. The core feature of the self-paced treadmill is a concave walking platform with an adjustable waist hardness that enables a safe, smooth, natural gait while adults with elevated BMI engage in an immersive walking and running motion. During the V-RATE intervention, participants will self-pace their locomotor action (walking/running/bending/ jumping) while they wear the VR headset and experience immersive VR adventure games using the Omniverse VR system.

Primary Outcomes

  • Change in depression from baseline to week 6-8 and one-month follow-up (Week 12) (Baseline, Week 6-8, Week 12)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-09-07
Completion: 2027-08-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The University of Texas at Arlington
Contact Information
Study Contact:
Donna L Schuman, PhD
18172723181
donna.schuman@uta.edu
Xiangli Gu, PhD
817-818-2106
xiangli.gu@uta.edu
Interventions
  • Device: Virtual Reality-based physical activity intervention — The V-RATE intervention will be delivered through a 360-degree non-mobilized treadmill in a university clinical laboratory for 6-8-weeks (1-2 days/week, 30 minutes/session) totaling 6 sessions. The V-RATE program will be focused on creating a safe and immersive environment supportive of physical activity. The treadmill enables an individual can walk and run at self-paced speed, moving in 360-degrees (i.e., forwards, sideways, and backwards) without risk of falling. The core feature of the self-paced treadmill is a concave walking platform with an adjustable waist hardness that enables a safe, smooth, natural gait while adults with elevated BMI engage in an immersive walking and running motion. During the V-RATE intervention, participants will self-pace their locomotor action (walking/running/bending/ jumping) while they wear the VR headset and experience immersive VR adventure games using the Omniverse VR system.
Study Locations (1 sites)
University of Texas at Arlington, Arlington, Texas 76019 United States
Eligibility Criteria
Inclusion Criteria: 1. Are between the ages of 18 and 45 2. Identify as a U.S. military veteran 4\. Normal vision (no colorblindness) Exclusion Criteria: 1. Unable to walk independently (e.g., use of any mobility assistive device such as brace, wheelchair, cane, crutch, walker, knee scooter) 2. Self-reported joint problem that limits mobility (e.g., arthritis or other condition that would prevent participation) or ongoing orthopedic injury 3. Self-reported pregnancy or suspicion of pregnancy 4. Self-reported motor disorder or impaired sense of motion or balance (such as Parkinsonism) 5. Self-reported color blindness 6. Self-reported neurological or cognitive disorder (e.g., TBI, history of seizure) 7. Self-reported cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.
Mpata Yathu Trial for Young Women in Zambia
NCT07132905
Not yet recruiting
Conditions HIV, Common Mental Health Problems, PTSD...
Phase NA
Enrollment 180
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to improve mental health and HIV-related outcomes among adolescent girls and young women (AGYW) in Zambia who have experienced gender-based violence (GBV). GBV includes physical, sexual, or emotional violence from partners or others and is known to increase the risk of depression, anxiety, post-traumatic stress, and HIV infection. In Zambia, access to mental health services is limited, especially for young women in low-resource communities. This study tests a counseling program called Mpata Yathu, which means "Our Space" in Chinyanja, designed to provide psychological support and improve well-being for young women who have faced violence and may be living with or at risk for HIV. Mpata Yathu is a culturally adapted version of the Friendship Bench, a lay counselor-delivered mental health intervention originally developed in Zimbabwe. In this adapted version, trained community lay counselors will deliver six individual problem-solving therapy (PST) sessions over a three-month period. Sessions will be delivered in private spaces within local Catholic churches in the Matero and Chawama areas of Lusaka, Zambia. Counseling sessions will also include referral options for participants who may need further support related to HIV care, GBV, or mental health concerns. The study is a two-arm randomized controlled trial. Participants will be randomly assigned to either: 1. Immediate Intervention Group - Receives the Mpata Yathu intervention between baseline and 3-month follow-up 2. Waitlist Control Group - Receives usual care for the first 3 months and then receives the Mpata Yathu intervention between 3- and 6-month follow-up A total of 180 young women (90 per group) will participate in the trial. To be eligible, participants must be between the ages of 15 and 24, reside in the Matero or Chawama area, report lifetime GBV exposure, and show moderate depressive symptoms or symptoms of common mental disorders (CMDs). They must also be living with HIV or report behaviors that place them at risk for HIV. The primary outcome is symptoms of CMDs, assessed using the Shona Symptom Questionnaire (SSQ-14). Secondary outcomes include depression, anxiety, and PTSD symptoms, as well as HIV-related outcomes such as clinic attendance, antiretroviral therapy (ART) adherence, and prevention behaviors such as condom use or PrEP readiness. The study will also measure feasibility, acceptability, and fidelity of the intervention. Data will be collected through surveys at baseline, 3 months, and 6 months. The research team will also monitor how the intervention is implemented, how participants respond to counseling, and whether counselors follow the therapy protocol. Participants will receive a small stipend for their time and transport at each counseling session and follow-up visit. This study is designed to test whether a trauma-informed, church-based mental health intervention can improve psychological well-being and HIV engagement among young women who…

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Mpata Yathu ("Our Space") — Mpata Yathu is a church-based, lay counselor-delivered psychological intervention adapted from the Friendship Bench problem-solving therapy (PST) model. Designed for adolescent girls and young women in Zambia with a history of gender-based violence and elevated mental health symptoms, the intervention includes six weekly individual PST sessions delivered in private spaces within Catholic churches. Lay counselors are trained in trauma-informed, survivor-centered care and offer optional referrals to mental health, HIV, or GBV-related services. Mpata Yathu maintains the core structure of Friendship Bench but was adapted through community-partnered participatory research to meet the sociocultural needs of Zambian youth.

Primary Outcomes

  • Change in symptoms of common mental disorders (CMDs) as measured by the Shona Symptom Questionnaire (SSQ-14) (Baseline and 3-month follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-09-22
Completion: 2026-06-30
Eligibility
Age: 15 Years
Sex: FEMALE
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, San Francisco
Collaborators: University of California, Los Angeles
Principal Investigators:
  • Charisse V Ahmed, PhD (PRINCIPAL_INVESTIGATOR) - University of California, San Francisco
Contact Information
Study Contact:
Moomba M Thornicroft, MPH
+260 97 4218181
mcpals4life@gmail.com
Charisse V Ahmed, PhD
charisse.ahmed@ucsf.edu
Interventions
  • Behavioral: Mpata Yathu ("Our Space") — Mpata Yathu is a church-based, lay counselor-delivered psychological intervention adapted from the Friendship Bench problem-solving therapy (PST) model. Designed for adolescent girls and young women in Zambia with a history of gender-based violence and elevated mental health symptoms, the intervention includes six weekly individual PST sessions delivered in private spaces within Catholic churches. Lay counselors are trained in trauma-informed, survivor-centered care and offer optional referrals to mental health, HIV, or GBV-related services. Mpata Yathu maintains the core structure of Friendship Bench but was adapted through community-partnered participatory research to meet the sociocultural needs of Zambian youth.
Study Locations (1 sites)
Not applicable (multi-site study), Lusaka, Zambia
Eligibility Criteria
Inclusion Criteria: To be eligible for enrollment in the RCT, participants must meet the following criteria: 1. aged 15 to 24 years; 2. Speak Nyanja, Bemba, and/or English fluently; 3. Reside in the Matero or Chawama constituency area during the time of recruitment; 4. Report lifetime exposure to GBV, as assessed by the following sections of the WHO Multi-country Study on Women's Health and Domestic Violence Against Women instrument: * Section 7 (Physical Violence by Intimate Partner): Reports of being slapped, pushed, hit with a fist, kicked, dragged, choked, or threatened/attacked with a weapon by a husband or partner. * Section 8 (Sexual Violence by Intimate Partner): Reports of being physically forced to have sex, having sex out of fear, or being forced to engage in degrading sexual acts by a husband or partner. * Section 9 (Emotional Abuse by Intimate Partner): Reports of being insulted, belittled, intimidated, or threatened by a partner. * Section 10 (Physical Violence by Non-Partner): Lifetime experiences of being beaten or physically mistreated by someone other than a partner since age 15. * Section 11 (Sexual Violence by Non-Partner): Forced sex or sexual acts since age 15 by a non-partner, and childhood sexual abuse before age 15. 5. Exhibit moderate depressive symptoms indicated by a score of 10-14 on the 9-item Patient Health Questionnaire (PHQ-9), or common mental disorder (CMD) symptoms (e.g., depression, anxiety) as indicated by a score of 9 or higher on the 14-item Shona Symptom Questionnaire (SSQ-14); and 6. Be living with HIV or demonstrate HIV risk behaviors, as defined by validated items from the World AIDS Foundation survey,25 including unprotected sex, multiple sexual partners, coerced sex, or transactional sex. Exclusion Criteria: Women will be excluded if they: 1. Require emergency treatment for any crisis (mental, physical, emotional) at the time of screening 2. Report severe symptoms of depression (score \> 14 on PHQ-9) or no to mild depression symptoms (PHQ-9 score \<10), and/or severe anxiety symptoms using the Generalized Anxiety Disorder 7-item scale or GAD-7 (score \>14 on GAD-7) 3. Have intellectual or cognitive disabilities that limit their ability to complete the screening tools, interact with a lay counselor and/or provide informed consent; and/or 4. Are considered in immediate danger (e.g., reoccurring physical violence) during time of the study. 5. Are currently receiving formal mental health counseling or psychotherapy (to avoid duplication of care and potential confounding effects).
Using TMS to Understand Neural Processes of Social Motivation
NCT06274112
Recruiting
Conditions Social Avoidant Behavior, Major Depressi...
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation. Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks. Adults in the Auburn/Opelika area and surrounding areas who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Basic Science Masking/blinding: Double

Interventions / Regimen

  • Device: TMS — TMS will be administered using a Cool B-65 coil to a personalized right dlPFC region.

Primary Outcomes

  • Social motivation (Immediately post-intervention)
  • Neural circuit function (Immediately post-intervention)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-30
Completion: 2029-07-31
Eligibility
Age: 25 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Auburn University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: TMS — TMS will be administered using a Cool B-65 coil to a personalized right dlPFC region.
Study Locations (1 sites)
Auburn University, Auburn, Alabama 36849 United States
Eligibility Criteria
Inclusion Criteria: * A diagnosis of Major Depressive Disorder OR a diagnosis of Social Anxiety Disorder (assessed/confirmed at screening visit). * Scoring above clinical threshold on a measure of social avoidant behavior (assessed/confirmed at phone screen). Exclusion Criteria: * Unstable psychotropic medication regimen (i.e., changes in psychotropic medication or dosage in past 3 months). * Current or lifetime diagnosis of Bipolar Disorder. * A diagnosis of substance use disorder within past 12 months. * A diagnosis of psychotic-spectrum disorder such as Schizophrenia. * Pregnancy or probable pregnancy. * Medical illness or medical treatment that would preclude or inhibit study participation. * Neurological disorder associated with brain damage. * History of seizures or head trauma with loss of consciousness \> 5 minutes. * Family history of epilepsy or personal epilepsy/seizures * Ferromagnetic implants or ferrmagnetic objects within body (e.g., pacemaker).
Treating Major Depression With Yoga Mono-therapy
NCT06091527
Recruiting
Conditions Depression Mild, Depression Moderate
Phase NA
Enrollment 180
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this single-center, single-blind, randomized, controlled, parallel group, interventional trial is to evaluate antidepressant efficacy of yoga monotherapy of 12-weeks duration in 180 adults meeting diagnostic criteria for mild-to-moderate major depression at the Zuckerberg San Francisco General Hospital. Researchers will compare the yoga interventions to an education control intervention on holistic healthcare.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Yoga practice — 90-minute group yoga classes twice weekly for 12 weeks.
  • Behavioral: Education — 90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.

Primary Outcomes

  • Change in Beck Depression Inventory-II score (Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-10-25
Completion: 2026-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, San Francisco
Principal Investigators:
  • Sudha Prathikanti, MD (PRINCIPAL_INVESTIGATOR) - University of California, San Francisco
Contact Information
Study Contact:
Sudha Prathikanti, MD
415-516-3867
sudha.prathikanti@ucsf.edu
Interventions
  • Behavioral: Yoga practice — 90-minute group yoga classes twice weekly for 12 weeks.
  • Behavioral: Education — 90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.
Study Locations (1 sites)
Zuckerberg San Francisco General Hospital, San Francisco, California 94110 United States
Eligibility Criteria
Inclusion criteria: * 18 years of age or older * Able to give voluntary, informed consent * English-speaking * Diagnosis of clinical depression Exclusion criteria: * Current use of antidepressant medication * Current engagement in psychotherapy * Current pregnancy * Significant medical issues interfering with yoga practice
Assessing the Effects of Cool Roofs on Indoor Environments and Health in Tavua, Fiji
NCT07592117
Not yet recruiting
Conditions Resting Heart Rate, Blood Glucose Contro...
Phase NA
Enrollment 800
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Ambient air temperatures in Fiji are increasing due to climate change. Solutions are needed to build heat resilience in communities and adapt. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in Fiji are susceptible to increased heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants. The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Fiji. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Tavua, Fiji.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Double

Interventions / Regimen

  • Other: Cool roof — Cool roofs are a heat-reflecting material that can be applied to existing household roofing in the form of a liquid-applied membrane. Cool roofs work by increasing solar reflectance (the ability to reflect the visible wavelengths of sunlight, reducing heat transfer to the surface) and thermal emittance (the ability to radiate absorbed solar energy) thereby reducing the amount of heat transferred into the home.

Primary Outcomes

  • Resting heart rate (Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.)
  • Blood glucose control (Two measurements will be taken: one at baseline and one in the last month of three consecutive hottest months.)
  • Depression (Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-05-18
Completion: 2027-09-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 800 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Aditi Bunker
Collaborators: Heidelberg University, Rutgers University, Boston University, Resene, Fiji National University
Principal Investigators:
  • Collin Tukuitonga (PRINCIPAL_INVESTIGATOR) - University of Auckland, New Zealand
Contact Information
Study Contact:
Aditi Bunker
+49 6221 565344
aditi.bunker@uni-heidelberg.de
Interventions
  • Other: Cool roof — Cool roofs are a heat-reflecting material that can be applied to existing household roofing in the form of a liquid-applied membrane. Cool roofs work by increasing solar reflectance (the ability to reflect the visible wavelengths of sunlight, reducing heat transfer to the surface) and thermal emittance (the ability to radiate absorbed solar energy) thereby reducing the amount of heat transferred into the home.
Study Locations (1 sites)
Fiji National University, Suva, Fiji
Eligibility Criteria
Inclusion Criteria: * Permanent household resident. Exclusion Criteria: * Roof damage, inaccessible or instability of roof adversely affecting cool roof coating application. * Participant unable to provide written/verbal informed consent.
Depressive Symptoms After Cardiac Surgery
NCT06706323
Recruiting
Conditions Cardiovascular Diseases, Coronary Artery...
Phase Not Applicable
Enrollment 300
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The primary goal of this project is to develop a predictive model for clinically significant depressive symptoms (CSDS) in patients undergoing coronary artery bypass graft (CABG) surgery, using pre- and perioperative data. CSDS occur in about 30 percent of CABG patients, which is four times higher than in the general population. These symptoms are linked to poor quality of life and increased morbidity and mortality. The aim is to create a model that can identify patients at risk for postoperative depression. This tool could help clinicians make informed decisions and take preventive measures to manage depression after surgery.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Patient Health Questionnaire (PHQ-9) score ≥10 (yes/no) at 6 weeks post-CABG (Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-11-25
Completion: 2027-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Roland von Känel
Collaborators: Triemli Hospital, ETH Zurich, University of Zurich
Principal Investigators:
  • Omer Dzemali, Prof. Dr. (PRINCIPAL_INVESTIGATOR) - Stadtspital Zürich Triemli, Klinik für Herzchirurgie, Birmensdorferstr. 497, 8063 Zurich, Switzerland
  • Roland v Känel, Prof. Dr. (PRINCIPAL_INVESTIGATOR) - University Hospital Zurich, Dept. of Consultation-Liaison Psychiatry, Haldenbachstr. 16/18, 8091 Zurich, Switzerland
Contact Information
Study Contact:
Roland v Känel, Prof. Dr.
+41 (0)44 255 52 51
roland.vonkaenel@usz.ch
Sinthujan Sivakumar, MSc
+41 (0)44 255 35 95
sinthujan.sivakumar@usz.ch
Interventions
N/A
Study Locations (2 sites)
Stadtspital Zürich (City Hospital Zurich) Triemli, Zurich, 8063 Switzerland
University Hospital Zurich (USZ), Zurich, 8091 Switzerland
Eligibility Criteria
Inclusion Criteria: * Elective Off-Pump CABG or CABG, either isolated or combined with valve intervention * Men and women, aged between 18 and 90 years * Sufficient knowledge of German language in reading and understanding * Oral and Signed consent form * Ability and Willingness to follow the study protocol Exclusion Criteria: * Cognitive impairment according to a score of ≤ 7 (maximum score = 9) on a modified version of a short version of the Mini-Mental State Examination and the Brief Interview for Mental Status * Any serious comorbid non-cardiac medical condition likely to cause death within 1 year (e.g. metastatic cancer) * Active psychotic symptoms (assessed with two items from the Youth Psychosis At Risk Questionnaire), substance abuse and/or dependence within the past 6 months (assessed with a single-item questionnaire), and/or active suicidal ideations (assessed with a single item from the M.I.N.I.). * Acute or emergency CABG
Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder
NCT04206969
Active, positions filled
Conditions Major Depressive Disorder
Phase NA
Enrollment 80
Locations 4 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The symptomatic and clinical expression of psychiatric disorders in children and adolescents is strongly influenced by the cultural setting they are growing up in. These cultural variations complicate psychiatric care, especially for migrant children, for whom appropriate care must be designed. Transcultural psychotherapy is an original psychotherapeutic technique developed to meet these specific requirements in France and in different European and American countries. Its theoretical and methodological foundations rest on the works of George Devereux in ethnopsychiatry (1970). A psychotherapeutic technique intended for first-generation migrants was developed by Tobie Nathan and coll (1986). Marie-Rose Moro and colleagues (1990) have adapted this technique to second-generation migrants. Indicated as a second-line treatment after the failure of standard management, this technique is fully formalized today. It comprises group consultations for the child and the family as a one-hour session each month, directed by a principal therapist, assisted by a group of co-therapists (of diverse cultural origins and occupations) and an interpreter in the family's mother tongue. The concept of culture is used to establish the therapeutic alliance, decode the symptoms, and propose treatment. The children and adolescents receiving this treatment have varied psychopathological profiles, mostly involving depressive and/or anxiety disorders. Specifically, migrants' children are especially vulnerable to depression, their psychiatric care is generally longer and less effective than in the general population, and their rate of treatment failure higher. Transcultural psychotherapy has demonstrated its value in these situations in numerous qualitative studies, but its efficacy has not yet been assessed by a method providing a high level of evidence, such as randomized controlled trials.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Supportive Care Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Transcultural psychotherapy — In addition to usual care, the participants receive transcultural psychotherapy

Primary Outcomes

  • Severity Score on the Improved Global Impression Scale (iCGI) to assess remission (at week 34 visit (v5))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2020-10-28
Completion: 2025-05
Eligibility
Age: 6 Years
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigators:
  • Jonathan LACHAL, PhD (PRINCIPAL_INVESTIGATOR) - Assistance Publique - Hôpitaux de Paris
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Transcultural psychotherapy — In addition to usual care, the participants receive transcultural psychotherapy
Study Locations (4 sites)
Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne, Bobigny, France
Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied, Clermont-Ferrand, France
Maison de Solenn, Cochin Hospital, Paris, 75000 France
Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse, Toulouse, France
Eligibility Criteria
Inclusion Criteria: * Be a child aged or an adolescent aged 6-20 years-old (this may be a declaratory age at the time of the consultation or based on a document for a residence request if no other identity documents are available) * Be a first or second-generation migrant (born abroad or born from at least one parent who is born abroad) * Have a psychological and/or psychiatric follow-up by a first-line care * Have been referred for transcultural psychotherapy by their first line care to treat depression resistant to standard management. * Present a depression according to the clinician who proposes the transcultural treatment (first line therapist), based on usual as well as cultural symptoms criteria of the below list: * Sadness * Diminish interest or pleasure in most of the usual activities * Insomnia or hypersomnia * Psychomotor agitation * Asthenia, loss of energy * Feeling of worthlessness or excessive guilt * Recurrent throughs of death * School problems (school failure, drop in grades, aggressivity with adult, school refusal…) * Mutism, and selective mutism * Runaways * Aggressivity * Impulsivity * Violence and delinquency * Conflicts with parents and adults from the community * Exclusion from family * Somatic pains * Massive separation anxiety * Regressive symptoms - loosing of an already acquired function such as speech, walk, stay alone for a sufficient time in relation to age, manage stress or anxiety for reasonable situations… * Denial of medical care for a chronic disease with no evident reasons * Cultural designation such as possessed by a spirit, being a child witch, or other cultural designations * State of trance The list is not exhaustive, and some other symptoms may be accepted if the first line clinician as well as the referent agree. The patients will be well characterized after inclusion. * Present a score \>= 4 on the iCGI - Severity at inclusion. * Present transcultural issues confirmed by the referent (usual procedure of indirect pre-selection based on the presentation of the situation by referring physician) * Have an informed consent signed by both parents/ one parent / tutor / adult patient (cf. 14.1 paragraph) Exclusion Criteria: * Patient or family has previously had transcultural psychotherapy * Patient presents an acute psychiatric disorder which hinders the realization of the transcultural therapy - for example, excited delirium with great psychic disorganization, or high suicidal risk patients. These situations will be excluded during the screening time based on the first line therapist evaluation * Patient presents an acute somatic disease which may hinder the well organization of the therapy * Patient addressed for a legal expertise * Child's/Adolescent's refusal * Pregnant or breastfeeding (for women for young women of childbearing age) * Participation in another interventional study * Patient under guardianship or curatorship
Does Social Media Impact Adolescent Mental Health?
NCT06049888
Recruiting
Conditions Mental Health
Phase NA
Enrollment 500
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The mental health of adolescents in the United States has seen a steep decline, roughly coinciding with the increasing popularity of social media and smartphones. But does social media have a causal impact on the mental health of adolescents or are concerns about the effect of social media on kids a form of public hysteria? In this study, the investigators will conduct the first field experiment in 10-14-year-olds to examine whether, how, and for whom social media harms mental health.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Basic Science Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Restricted Social Media — Participants (N = 500) will be randomly assigned to either have no study-imposed restrictions on social media use (naturalistic social media condition) or have no access to social media apps on their phones (restricted social media condition). This manipulation will last three months, after which both groups will have no study-imposed restrictions on social media for three more months.

Primary Outcomes

  • Revised Child Anxiety and Depression Scale (RCADS-25): Total Score (Baseline, three months, and six months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-09-29
Completion: 2028-06-01
Eligibility
Age: 10 Years
Sex: ALL
Volunteers: true
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Georgetown University
Collaborators: National Institutes of Health (NIH)
Contact Information
Study Contact:
Kostadin Kushlev, PhD
804-585-4385
kk1199@georgetown.edu
Interventions
  • Behavioral: Restricted Social Media — Participants (N = 500) will be randomly assigned to either have no study-imposed restrictions on social media use (naturalistic social media condition) or have no access to social media apps on their phones (restricted social media condition). This manipulation will last three months, after which both groups will have no study-imposed restrictions on social media for three more months.
Study Locations (1 sites)
Georgetown University, Washington D.C., District of Columbia 20057 United States
Eligibility Criteria
Inclusion Criteria: 1. is an adolescent who is between the ages of 10 and 14; 2. is an adolescent whose parents have decided to buy them their first smartphone; 3. is an adolescent both of whose parents/guardians consent for them to be in the study; 4. is an adolescent who assents to be in the study; 5) is an adolescent who speaks and reads English sufficiently to complete surveys and provide informed consent. Exclusion Criteria: 1. is an adolescent who has severe developmental problems (e.g., autism, severe language delay); 2. is an adolescent who is currently or has ever been diagnosed with severe or moderately severe mental illness; 3. is an adolescent who is currently or has ever experienced suicidal ideation.
Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity
NCT07718646
Recruiting
Conditions Food Insecurity
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a pilot study testing a mobile app that is designed to help mothers experiencing food insecurity manage stress and build coping skills. Participants will use the app for 8 weeks and complete surveys about their experiences, mental health, and coping. The study will help us learn whether the app is helpful and feasible for future research.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Behavioral: MOMent — An 8-week behavioral intervention delivered through a mobile application that combines multiple behavior change techniques, including coping education, self-monitoring, goal setting, and skill-building reflections The intervention is designed to help participants develop and practice coping strategies to manage stress and improve mental well-being.

Primary Outcomes

  • Recruitment feasibility (Evaluated throughout recruitment and at completion of the recruitment period)
  • Intervention retention (Measured from enrollment through completion of post-intervention data collection (8 weeks))
  • App Engagement (Measured throughout the 8-week intervention period)
  • Usability (Measured at post-intervention (8 weeks))
  • Participant Acceptability (Measured at post-intervention (8 weeks))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-07-20
Completion: 2026-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Oklahoma State University
Contact Information
Study Contact:
Rachel Liebe
405-744-5043
rachel.liebe@okstate.edu
Interventions
  • Behavioral: MOMent — An 8-week behavioral intervention delivered through a mobile application that combines multiple behavior change techniques, including coping education, self-monitoring, goal setting, and skill-building reflections The intervention is designed to help participants develop and practice coping strategies to manage stress and improve mental well-being.
Study Locations (1 sites)
Oklahoma State University, Stillwater, Oklahoma 74078 United States
Eligibility Criteria
Inclusion Criteria: * Reside in Oklahoma * Identify as a woman or non-binary * At least 18 years old * Have a child under 18 years old living in your household * Experienced food insecurity in the past 30 days Exclusion Criteria: * Currently undergoing mental health counseling * No access to a smartphone (Apple or Android)
The Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality, Depression
NCT06750796
Recruiting
Conditions Infant, Newborn, Maternal Outcome
Phase NA
Enrollment 128
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression.

Design

Study type: Interventional Phases: Allocation: Non Randomized Intervention model: Single Group Primary purpose: Supportive Care Masking/blinding: None

Interventions / Regimen

  • Behavioral: The Half Swaddling Application — Half swaddling application in term babies

Primary Outcomes

  • Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months (Postpartum first 3 months)
  • Pittsburgh Sleep Quality Index (up to 3 months)
  • Edinburgh Postnatal Depression Scale (up to 3 months)
  • Short Infant Sleep Routine Questionnaire (up to 3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-05-18
Completion: 2025-12-15
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 128 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Tanta University
Contact Information
Study Contact:
Hatice Kahyaoglu Sut, 1.
05337662979
haticesut@yahoo.com
Interventions
  • Behavioral: The Half Swaddling Application — Half swaddling application in term babies
Study Locations (1 sites)
Trakya University, Edirne, None Selected 22030 Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * 18-45 years old, * Term birth (single birth over 37 weeks), * After an uncomplicated pregnancy process, the delivery was completed by normal vaginal or cesarean delivery method, * Not using cigarettes, alcohol and stimulants, * BMI\<30, * Not working on night shift, * Stable vital signs, * Those who have not received infertility treatment, * Do not have a chronic disease (such as hypertension, diabetes mellitus), * Not experiencing serious depression, anxiety and stress, * Not having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.), * No serious maternal complications, * Mothers who volunteered to participate in the study will be included in the study. For baby; * Birth weight over 2500 g, * Stable vital signs, * APGAR score above 7, * No serious neonatal complications, * Midwives without congenital malformations will be included in the study. Exclusion Criteria: * under 18 years old, * Preterm birth (under 37 weeks and/or multiple births), * Incomplete delivery by normal vaginal or cesarean delivery method after a complicated pregnancy process, * Using cigarettes, alcohol and stimulants, * BMI\>30, * Working night shift, * No stable vital signs, * Having received infertility treatment, * Having a chronic disease (such as hypertension, diabetes mellitus), * Experiencing severe depression, anxiety and stress, * Having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.), * Serious maternal complication, * Mothers who do not volunteer to participate in the study will not be included in the study. For baby; * Birth weight of 2500 g and below, * No stable vital signs, * APGAR score below 7, * Serious neonatal complication, * Babies with congenital malformations will not be included in the study.
Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention
NCT03852082
Active, positions filled
Conditions Coronary Heart Disease, Percutaneous Cor...
Phase Not Applicable
Enrollment 2600
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A prospective, multicenter, registered cohort study to observe the incidence of 1-year major adverse cardiac events in patients with coronary heart disease co-morbid depression treated with percutaneous coronary intervention and to clarify the predictors of 1-year major adverse cardiac events post PCI among these patients.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Procedure: percutaneous coronary intervention — Patients with coronary heart disease co-morbid depression post percutaneous coronary intervention.

Primary Outcomes

  • Number of Participants with Major Adverse Events (36-month)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2019-08-28
Completion: 2026-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nanjing First Hospital, Nanjing Medical University
Principal Investigators:
  • Shaoliang Chen, phd (STUDY_CHAIR) - Nanjing First Hospital, Nanjing Medical University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Procedure: percutaneous coronary intervention — Patients with coronary heart disease co-morbid depression post percutaneous coronary intervention.
Study Locations (1 sites)
Nanjing First Hospital, Nanjing, Jiangsu 210006 China
Eligibility Criteria
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures; 2. Men and women 18 years or older; 3. Diagnosed CHD needed to and can be treated with PCI according to the guidelines of ACC/AHA; 4. Willingness to participate in the follow-up study for at least 1 year. Exclusion Criteria: 1. Inability to provide written informed consent; 2. Diagnosed mental illness or medical history (including schizophrenia, bipolar disorder, severe dementia or Lifetime alcohol or substance abuse); 3. Tendency of suicide; 4. Pregnant or lactating women; 5. Any physical or intellectual inability or disability that may affect completion of self-assessment tools, study protocol and follow-up requirements; 6. Any other reasons that investigators based on professional judgments that would place the patient at increased risk. 7. Patient with STEMI within 24-hour from the onset of chest pain to admission.
The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression
NCT06398496
Recruiting
Conditions Depressive Disorder, Major
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to investigate the effects of a 12-week aerobic (cardio) exercise intervention in people with Major Depressive Disorder. Measurements taken before, during, and following the 12-week intervention will include assessments of cognition, cardiorespiratory fitness, stress, mood and emotion, and gut bacteria.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Basic Science Masking/blinding: None

Interventions / Regimen

  • Behavioral: Aerobic Exercise — Aerobic exercise intervention will involve multiple exercise sessions completed (unsupervised) by participants. Exercise programs will be given to participants, matched to their current level of fitness as determined via a maximal cardiorespiratory fitness test, and will be adjusted via progressive overload every 1-2 weeks by an exercise and sports science professional.

Primary Outcomes

  • Depression symptom change (Change from baseline at 12-weeks)
  • Negative and positive affect change (Change from baseline at 12-weeks)
  • Gut microbiota change (Change from baseline at 12-weeks)
  • Cognitive performance: affective perceptual bias (Change from baseline at 12-weeks)
  • Cognitive performance: social cognition (Change from baseline at 12-weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-02-14
Completion: 2026-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University College Cork
Principal Investigators:
  • Gerard Clarke, PhD (PRINCIPAL_INVESTIGATOR) - University College Cork, APC Microbiome Ireland
Contact Information
Study Contact:
Move4Mood Study Recruitment
(+353) 021 4901721
move4mood@ucc.ie
Nathan D Nuzum, PhD
nnuzum@ucc.ie
Interventions
  • Behavioral: Aerobic Exercise — Aerobic exercise intervention will involve multiple exercise sessions completed (unsupervised) by participants. Exercise programs will be given to participants, matched to their current level of fitness as determined via a maximal cardiorespiratory fitness test, and will be adjusted via progressive overload every 1-2 weeks by an exercise and sports science professional.
Study Locations (1 sites)
University College Cork, APC Microbiome Ireland, Cork, Cork County Ireland
Eligibility Criteria
Inclusion Criteria: * Be able to give written informed consent. * Be between 18 and 59 years of age. * Be in generally good health as determined by the investigator (excluding Major Depressive Disorder diagnosis). * Community dwelling with a current diagnosis of Major Depressive Disorder, and current depression episode/symptoms as determined via Beck's depression inventory-II (score 13-31). Exclusion Criteria: * Change of pharmacological therapy less than 2 weeks prior to beginning of study (including beginning pharmacological treatment). * Have a significant acute or chronic coexisting illness \[cardiovascular, gastrointestinal (GI) \[including functional GI disorders, inflammatory bowel disease, coeliac disease\], immunological, psychiatric \[to include formal/clinical diagnosis or as determined via participant self-report i.e., bipolar spectrum disorder, schizophrenia, or psychosis, but not anxiety disorder\], neurodevelopmental or neurodegenerative disorders, metabolic disorders \[to include type I or II diabetes\], or any condition which contraindicates, in the investigators judgement, entry to the study (including conditions which may prevent an individual from safely participating in low-to-moderate exercise intensities (57-76% heart rate max \[HRmax\], rating of perceived exertion \[RPE\]:9-13 (13))-i.e., cardiorespiratory disease\[s\]). * Have a malignant disease or any concomitant end-stage organ disease. * Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results; to include anti- inflammatory drugs, corticosteroids, laxatives, enemas, proton-pump inhibitors, antibiotics, or probiotics (within 1 month of starting study), anti-coagulants, thrombocyte-aggregation blocking medication(s) and over-the counter non-steroidal analgesics. Participants should have a wash-out period of four-weeks of the above-mentioned medication to be eligible for participation. * Individuals who are considered to be poor attendees, in the opinion of the investigator, or unlikely for any reason to be able to comply with the trial. * Participants must not be currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study. * Are meeting the national physical activity guidelines (16) (i.e., at least 30 minutes a day of moderate intensity activity, five days a week (or 150 minutes a week), specifically in relation to structured aerobic exercise, as assessed via the international physical activity questionnaire (IPAQ). NB: if guidelines are met from occupational or incidental physical activity, individuals would not meet exclusion criteria. * Current perimenopause, menopause, or post-menopause, in the case of females. * Females who are pregnant, planning a pregnancy within duration of the study intervention period, or currently lactating. * Participants who are not fluent in English or English is not first language. * Are colour blind. * Have dyslexia or dyscalculia. * Are a current habitual daily smoker. * Regular, illegal drug use. * Alcohol abuse disorder. * Acute suicidality or suicide attempt in the past 6 months. * Current eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder).
Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use
NCT06878859
Recruiting
Conditions Depression - Major Depressive Disorder, ...
Phase NA
Enrollment 80
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Amplification of Positivity - Cannabis Use (AMP-C) — AMP-C is a smartphone-based digital intervention that includes activities that focus on positivity (e.g., noticing and capitalizing on positive events) to increase positive emotions, thoughts, and behaviors. The role and impact of CU on the maintenance of depression and reward dysfunction (and vice versa), is intertwined throughout the intervention.

Primary Outcomes

  • Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9) (Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention)
  • Change in Cannabis Use Frequency (Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory; DFAQ-CU) (Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention)
  • Usability (System Usability Scale; SUS) (Post-Intervention (approximately one week after completing intervention))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-02-23
Completion: 2029-06-29
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Massachusetts General Hospital
Collaborators: National Institute on Drug Abuse (NIDA)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Amplification of Positivity - Cannabis Use (AMP-C) — AMP-C is a smartphone-based digital intervention that includes activities that focus on positivity (e.g., noticing and capitalizing on positive events) to increase positive emotions, thoughts, and behaviors. The role and impact of CU on the maintenance of depression and reward dysfunction (and vice versa), is intertwined throughout the intervention.
Study Locations (1 sites)
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Eligibility Criteria
Inclusion Criteria: * Aged ≥ 18 years * Resides in the United States * Able to read and understand English and willing to provide informed consent/comply with the study protocol * Moderate depressive symptom severity, as indicated by the Patient Health Questionnaire-9 (PHQ-9) * Problematic cannabis use, as indicated by the Cannabis Use Disorder Identification Test - Revised (CUDIT-R) * Current elevated anhedonia, as indicated by the PHQ-9 * Interest in receiving treatment for their cannabis use and depression * Meet criteria for current MDD and CUD per the DSM-5 Exclusion Criteria: * History of a psychotic disorder or bipolar disorder type I/II * Active suicidal ideation or intent based on the Columbia-Suicide Severity Rating Scale * Current psychotherapy engagement * Changes in psychotropic medication within six weeks of the start of study
Multidimensional Sleep Health Intervention to Optimize Concussion Recovery
NCT07082218
Recruiting
Conditions Concussion (Diagnosis), Concussion, Mild...
Phase NA
Enrollment 54
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Behavioral: Sleep Intervention — The investigators will randomly assign participants (adolescents with concussion) to a personalized sleep schedule and sleep health recommendation, based on a meeting with an administrator after enrollment and randomization. They will undergo testing prior to the intervention, after the intervention (2 weeks after the initial visit, intervention length=2 weeks), and 6 weeks after intervention completion.

Primary Outcomes

  • Concussion symptom resolution time (Through study completion, an average of 8 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-10
Completion: 2027-06-15
Eligibility
Age: 10 Years
Sex: ALL
Volunteers: false
Enrollment: 54 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Principal Investigators:
  • David R Howell, PhD (PRINCIPAL_INVESTIGATOR) - University of Colorado Denver | Anschutz
Contact Information
Study Contact:
David R Howell, PhD
7207771502
David.Howell@CUAnschutz.edu
Katelyn Hurlburt, BS
7207771502
Katelyn.Hurlburt@CUAnschutz.edu
Interventions
  • Behavioral: Sleep Intervention — The investigators will randomly assign participants (adolescents with concussion) to a personalized sleep schedule and sleep health recommendation, based on a meeting with an administrator after enrollment and randomization. They will undergo testing prior to the intervention, after the intervention (2 weeks after the initial visit, intervention length=2 weeks), and 6 weeks after intervention completion.
Study Locations (1 sites)
University of Colorado Denver, Aurora, Colorado 80045 United States
Eligibility Criteria
Inclusion Criteria: * Participants will be symptomatic at the time of enrollment (Post-Concussion Symptom Inventory \[PCSI\] score ≥9) * Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria * 10-19 years of age (aligned with World Health Organization definition of 'adolescent') Exclusion Criteria: * History of treatment for pre-concussion sleep-related disorders
Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
NCT05838560
Active, positions filled
Conditions Schizophrenia, Treatment Resistant Depre...
Phase PHASE2
Enrollment 40
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This pilot open-label study examines the effects of a combination of dasatinib plus quercetin - two drugs that have known senolytics properties - on physiological aging in older individuals with depression or schizophrenia.

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Drug: Dasatinib — dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.
  • Drug: quercetin — The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.

Primary Outcomes

  • Number of participants who successfully completed and safely tolerated the intervention (10 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2023-07-01
Completion: 2027-10-01
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Washington University School of Medicine
Collaborators: UConn Health
Principal Investigators:
  • Eric Lenze, MD (PRINCIPAL_INVESTIGATOR) - Washington University School of Medicine, Department of Psychiatry
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Dasatinib — dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.
  • Drug: quercetin — The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.
Study Locations (1 sites)
Washington University School of Medicine, St Louis, Missouri 63110 United States
Eligibility Criteria
Inclusion Criteria: 1. Either major depression, which is treatment-resistant (currently depressed despite at least 2 adequate trials of antidepressants in this or the previous episode), or schizophrenia/schizoaffective disorder. 2. Age 50+ (60+ for depression). 3. Three conditions associated with aging (e.g., hypertension/diabetes/metabolic syndrome, cardiac disease, lung disease other than asthma, cancer with adult-onset, arthritis, and inflammatory diseases typically seen in aging). 4. No history of dementia by patient report. 5. Already taking an adequate dose of medication for schizophrenia/schizoaffective disorder or depression. Exclusion Criteria: 1. Contraindications for dasatinib or quercetin 2. Active SI such that participant could not be safely managed in an outpatient clinical trial. 3. Taking medications that are strong CPY3A4 inhibitors or strong inducers, or that induce senescence (e.g., alkylating agents, anthracyclines, platins/other chemotherapy), or everolimus and topotecan (which have interactions with quercetin). 4. All medications and medical conditions will be reviewed by physician study investigators to determine whether the medication or condition, in the opinion of the investigators, makes the participant inappropriate for the study. Examples of such potential excluding conditions: Active inflammatory, infectious, or malignant disease; sensory deficits that would interfere with assessments; recent heart attack or stroke; severe bleeding disorder; uncontrolled hypertension or diabetes mellitus; active liver disease or cirrhosis; current use of systemic steroids, quinolone antibiotics, hydroxychloroquine or chloroquine.
Functional Assessments in Vision Impairment
NCT06908161
Not yet recruiting
Conditions Retinitis Pigmentosa (RP), Diabetic Reti...
Phase Not Applicable
Enrollment 45
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The aim of the research project is to validate the use of a novel functional assessment tool designed to document how participants with a vision impairment complete activities of daily living in a real world environment.

Design

Study type: Observational Observational model: Cohort Time perspective: Cross Sectional

Primary Outcomes

  • Evaluating validity and reliability (From enrolment to assessment could range from 2 to 4 weeks.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-04-01
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 45 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Center for Eye Research Australia
Principal Investigators:
  • Penelope J Allen, FRACO, FRACS (PRINCIPAL_INVESTIGATOR) - Center for Eye Research Australia
Contact Information
Study Contact:
Lisa Lombardi, BOptom
+61 3 9959 0119
llombardi@cera.org.au
Lauren Moussallem, BAppSc MOrth
lmoussallem@unimelb.edu.au
Interventions
N/A
Study Locations (1 sites)
Centre for Eye Research Australia, Melbourne, Victoria 3002 Australia
Eligibility Criteria
Inclusion Criteria: 1. Willing to provide signed informed consent. 2. Be available for study visits. 3. Willing to comply with study assessments. 4. In good general health and ambulant. 5. Aged over 18 years of age. 6. Have a vision impairment caused by any ocular condition which affects independent mobility. 7. Agree to allow the research team into their home and local environments. 8. Participate in assessments in public settings Exclusion Criteria: 1. Significant co-morbidities which prohibit involvement in study visits. 2. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. 3. Cognitive deficiencies, including dementia or progressive neurological disease. 4. Have a psychiatric condition that, in the investigator's opinion, precludes compliance with the protocol including past or present psychoses and bipolar disorder. 5. Deafness or significant hearing loss. 6. Inability to converse in English.
Investigating Behavior Change Methods for the Management of Hypertension
NCT07631546
Active, positions filled
Conditions Hypertension
Phase NA
Enrollment 37
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This project aims to promote general wellness using a mobile health intervention that incorporates health coaching to help manage hypertension. The mobile application (HyperCoach) does not intend to cure, mitigate, or prevent hypertension. The main questions it aims to answer are: 1. Does digital mobile health coaching impact hypertension management outcomes, including blood pressure and adherence? 2. How does adherence to mobile health intervention influence the long-term man-agement and outcomes of hypertension? 3. How are health beliefs and QOL affected by digital coaching and health tracking for hypertension management? Participants will be required to complete the following: Blood pressure reading every day Weight reading every day Take hypertension medication as prescribed by their physician Complete educational content (if on coaching group) Belief and Attitudes Survey (before and after study) Personality Assessment Survey Demographic Information Survey Hypertension Health Literacy Survey (before and after study) Two General Health Literacy Surveys (before and after study) Quality of Life Survey

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Digital Coaching Plan — The participants will have the opportunity to establish their own personal health goals for blood pressure, resting heart rate, weight, and step count in HyperCoach. At the end of every week, participants will have the opportunity to have a progress report available to them to demonstrate their current trends regarding their weight, blood pressure, resting heart rate, and step count. The progress report will also allow users to change their current goals to more appropriate ones according to their health and knowledge development. The participants will be provided with a Bluetooth-enabled blood pressure cuff and weight scale. The devices will be used alongside the participants' IOS phones to collect their blood pressure and weight readings through the use of the iPhone Application - HyperCoach. The application will provide the participants with American Heart Association (AHA) approved content in the form of flyers, messages, and videos.
  • Behavioral: Health Awareness — Daily reminders to monitor bloodp pressure and weight , mobile platform functions are disabled except for biofeedback and trend graphs.

Primary Outcomes

  • Change in Baseline Systolic Blood Pressure (From enrollment to Day 90 and 270 of the intervention.)
  • Change in Baseline Diastolic Blood Pressure (From enrollment to the end of the treatment at Day 90 and 270.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2023-08-31
Completion: 2026-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 37 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Texas A&M University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Digital Coaching Plan — The participants will have the opportunity to establish their own personal health goals for blood pressure, resting heart rate, weight, and step count in HyperCoach. At the end of every week, participants will have the opportunity to have a progress report available to them to demonstrate their current trends regarding their weight, blood pressure, resting heart rate, and step count. The progress report will also allow users to change their current goals to more appropriate ones according to their health and knowledge development. The participants will be provided with a Bluetooth-enabled blood pressure cuff and weight scale. The devices will be used alongside the participants' IOS phones to collect their blood pressure and weight readings through the use of the iPhone Application - HyperCoach. The application will provide the participants with American Heart Association (AHA) approved content in the form of flyers, messages, and videos.
  • Behavioral: Health Awareness — Daily reminders to monitor bloodp pressure and weight , mobile platform functions are disabled except for biofeedback and trend graphs.
Study Locations (1 sites)
Texas A&M University, College Station, Texas 77843 United States
Eligibility Criteria
Inclusion Criteria: * Reliable internet access for mobile device (either WIFI or mobile data plan) * iOS (14+) smarthphone (iPhone 6S or newer) * Fluent in English or Spanish * Participant is taking hypertension medication * Diagnosis is hypertension * 18+ years of age Exclusion Criteria: * Diagnosed with resistant hypertension