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About This Study

The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes. The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care. Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.

Design

Interventions / Regimen

• Other: Comprehensive medication management with PGx testing results — A comprehensive medication management with PGx testing includes a pharmacist-provided review of health history, past/current medications, and assessment of potential medication related problems. A review of PGx testing results will be integrated to identify any PGx-related medication issues. Recommendations will then be made to study participants' providers (regular care team) for any decisions regarding potential therapy changes.
• Other: Usual Care — Participants will receive no study intervention (usual care) and will have a comprehensive medication management with review of PGx testing results at the end of the study.

Primary Outcomes

• Change in Patient Health Questionnaire (PHQ-8) score (Baseline, 6 Weeks, 12 Weeks, 6 Months)

About This Study

At the moment, the number of people with long COVID is unkown because there is still no effective diagnosis. This is why is very important to analyze the most common symptoms, which are: depression, anxiety and fatigue. This project seeks to analyze some blood components of people with long COVID, such as microRNAs and vitamin B12, in order to identify the body processes that changed after COVID-19 and thereby design better therapies and diagnostic methods focused on each of them. The hypothesis is that the expression of miR-21, -146a and -155 will be overexpressed as well as there will be a deficiency of vitamin B12 in serum in subjects suffering from long COVID with neurological symptoms of depression, anxiety and fatigue.

Design

Primary Outcomes

• Change of microRNA expression between long COVID group and control group (immediately after the blood extraction)
• Change of vitamin B12 concentration between long COVID group and control group (immediately after the blood extraction)
• Link the expression of microRNAs with the score obtained in the instruments to evaluate depression, anxiety and fatigue (immediately after the blood extraction)
• Link the concentration of vitamin B23 with the score obtained in the instruments to evaluate depression, anxiety and fatigue. (immediately after the blood extraction)

About This Study

This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD. This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.

Design

Interventions / Regimen

• Behavioral: Active Closed Loop Real Time fMRI Neurofeedback — Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
• Behavioral: Sham Closed Loop Real Time fMRI Neurofeedback — Sham (placebo) neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)

Primary Outcomes

• Montgomery Asberg Depression Rating Scale (MADRS) (3 months)

About This Study

This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.

Design

Interventions / Regimen

• Other: Opioid tapering with CBT and education — Patients in the opioid tapering plus CBT group will set up an initial meeting with the pain physician within a few days of enrollment to set the tapering schedule. They will also have two CBT appointments set up to complete via telemedicine during the time between enrollment and surgery.
• Other: Opioid tapering with education alone — Patients in this group will be instructed to continue their opioids at the same doses and frequencies they were taking up through the day of surgery. They will set up an initial meeting within a few days of enrollment with the chronic pain physician to determine the tapering schedule which will occur over 4 weeks or more leading into surgery. The patient and pain physician will collectively agree on a tapering schedule.

Primary Outcomes

• proportion that achieved opioid tapering goal (Perioperative prior to surgery (postoperative day 0))

About This Study

This study, which is being conducted as part of a Quality Improvement (QI) Initiative at Columbia University Irving Medical Center, will test whether delivering the iHeart DepCare tool increases real world reach and adoption of depression treatment among CHD patients. As part of the QI Initiative, Clinic Navigators will administer and record (in EPIC) depression screening in advance of primary care and cardiology appointments. Eligible patients with elevated depressive symptoms will be randomized to receive usual care vs. the iHeart DepCare tool in conjunction with brief motivational, technical and navigation support per patient preference. Aim 1: To test the effect of iHeart DepCare on depression treatment optimization (primary outcome) among coronary heart disease patients with elevated depressive symptoms. Aim 2: To explore the effect of iHeart DepCare on implementation outcomes, including provider referrals, among coronary heart disease patients with elevated depressive symptoms.

Design

Interventions / Regimen

• Behavioral: iHeart Depcare tool — The iHeart DepCare tool is an electronic patient activation and psychoeducation tool (available in English and Spanish) designed to bridge depression screening with treatment. The tool includes: 1) a description of depressive symptoms; 2) a checklist of behavioral risk factors; 3) an animation of a CVD patient going through the process of symptom recognition, help seeking, and treatment completion following a CVD event; 4) psychoeducation videos; 5) depression treatment selection support (adapted to include behavioral risk factor preferences); and 6) additional cardiac resources the patient can reference. Patients may receive brief motivational interviewing as well as technical/navigational support per patient preference to reinforce learning. Patient treatment preferences are sent via EPIC to the mental health and treating providers.

Primary Outcomes

• Percentage of eligible patients who initiate or intensify depression treatment (Up to 6 months)

About This Study

This NIH-funded single-arm pilot tests the feasibility, acceptability, and preliminary effects of embedding brief guided mindfulness practice (via the Waking Up smartphone app) into the inter-session intervals of clinically administered accelerated intermittent theta-burst stimulation (aiTBS) for major depressive disorder (MDD). Participants receive aiTBS as standard clinical care at MUSC; the research intervention is daily guided mindfulness practice during the aiTBS course. Outcomes include feasibility/acceptability, changes in state mindfulness and hedonic tone (Day 0 to Day 5), perceived ease of meditation, trait mindfulness at 4 and 12 weeks, and durability of antidepressant response (PHQ-9) at 4 and 12 weeks.

Design

Interventions / Regimen

• Behavioral: Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app — 5-15 minutes of mindfulness exercises during aiTBS inter-session intervals (9 total per day) for five consecutive treatment days; optional additional practices allowed. App analytics (with permission) and self-reports quantify engagement.

Primary Outcomes

• Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate) (Day 0 to Day 5)
• Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events) (Day 0 to Day 5)

About This Study

The objective of this clinical trial is to evaluate the efficacy and safety of sertraline combined with multi-strain probiotics in adolescents aged 12-18 with major depressive disorder. The primary research question is whether sertraline combined with multi-strain probiotics is superior to sertraline combined with placebo in alleviating depressive symptoms and improving mood symptoms in adolescents. If there is a control group: researchers will compare sertraline combined with multi-strain probiotics with sertraline combined with placebo (a substance that looks similar but does not contain probiotics) to determine whether adding multi-strain probiotics provides greater therapeutic benefits for adolescent patients with depression. Participants will: 1. Undergo 8 weeks of treatment with sertraline combined with multi-strain probiotics or sertraline combined with placebo; 2. Have clinical visits every 4 weeks for clinical assessments and safety monitoring.

Design

Interventions / Regimen

• Drug: Sertraline — Weeks 1-4, the starting dose of sertraline is 25 mg/day, adjusted according to the clinical assessment of the psychiatrist, with a dosage range of 25-150 mg/day. By week 4, the sertraline dosage should reach at least 150 mg/day; placebo powder, 1 sachet/day.

Primary Outcomes

• Change in Children's Depression Rating Scale - Revised (CDRS-R) scores (Assessments will be performed at baseline, week 4, and week 8)

About This Study

The purpose of the study is to evaluate a trauma informed digital multicomponent intervention design to improve health and safety outcomes for women with lifetime exposures to violence and co-occurring PTSD and/or depression symptoms

Design

Interventions / Regimen

• Behavioral: BSHAPE — BSHAPE is designed to comprehensively assess cumulative exposures to violence, evaluate current safety needs, and provide components to mitigate trauma-related symptoms (e.g., mental health challenges, HIV/STI risk). It promotes health and resilience through psycho-education, skill-building, and mindfulness-based stress reduction practices.
• Other: Control (general wellness) — The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.

Primary Outcomes

• Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10) (Baseline (1st month), 3, 6 and 12 months)
• Depression as Assessed by The Patient Health Questionnaire-9 (PHQ-9) (Baseline (1st month), 3, 6 and 12 months)
• PTSD as Assessed by The PTSD Checklist-Civilian Version (PCL-C) (Baseline (1st month), 3, 6 and 12 months)
• Self-Protection Behavior Checklist (Baseline (1st month), 3, 6 and 12 months)
• Empowerment for Safety as Assessed by The Adapted Measure of Victim Empowerment Related to Safety (MOVERS) (Baseline (1st month), 3, 6 and 12 months)
• Self-Care Behaviors as Assessed by The Mindful Self-Care Scale (MSCS) and The Behavioral Activation for Depression Scale-Short Form (BADS-SF) (Baseline (1st month), 3, 6 and 12 months)

About This Study

Cognitive-behavioural therapy (CBT) has a robust evidence base for treating anxiety disorders and depression, including transdiagnostic CBT. Internet-based CBT (iCBT) offers a new approach to delivering these therapies. iCBT is a digital adaptation of traditional CBT that leverages digital platforms to deliver similar therapeutic interventions. iCBT encompasses structured programmes that provide users with tools and techniques to manage mental health issues such as depression and anxiety. The digital format ensures timely access to CBT and typically includes interactive modules, videos, self-assessment tools, and virtual therapist support. This study aims to evaluate the effectiveness of iCBT in reducing symptoms of anxiety and depression, as well as its cost-effectiveness and acceptability in local context. The main questions it aims to answer are: 1. Do participants receiving iCBT show a reduction in symptoms of anxiety and/or depression, and does the effectiveness of iCBT vary based on individual user characteristics? 2. What are the factors that influence the acceptance, adoption, and engagement rates of iCBT among Singaporeans? 3. Is iCBT more cost-effective as compared to usual care? Researchers will compare guided iCBT to usual care (traditional CBT) to assess iCBT's clinical effectiveness, cost-effectiveness, and acceptability in Singapore's primary and community healthcare settings. Participants in the intervention group will: 1. Undergo guided iCBT intervention consisting of 8 weeks of online modules covering core CBT techniques 2. Counsellors will schedule 3 regular check-ins 3. Questionnaires will be administered at 5 timepoints 4. Selected participants will be invited for a semi-structured interview to assess their experiences with iCBT Participants in the control group will: 1. Continue usual care 2. Questionnaires will be administered at 5 timepoints A parallel qualitative study involving service providers is required to contextualise trial findings, identify implementation barriers and enablers and inform national scale-up and policy decisions. It aims to explore service providers' experiences, perceptions and contextual factors influencing the implementation of iCBT within routine primary-care and community mental-health services participating in this trial.

Design

Interventions / Regimen

• Behavioral: Internet-delivered cognitive behavioural therapy (iCBT) — Guided iCBT in Singapore for mild-to-moderate anxiety and/or depression

Primary Outcomes

• Change in the depression scores (PHQ-9) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months (Baseline, 5 weeks, 8 weeks, 3 months, 6 months)
• Change in the anxiety scores (GAD-7) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months (Baseline, 5 weeks, 8 weeks, 3 months, 6 months)
• Change in the functional scores (WHODAS 2.0) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months (Baseline, 5 weeks, 8 weeks, 3 months, 6 months)

About This Study

Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.

Design

Interventions / Regimen

• Behavioral: Standard Doula Care Plus PMAD Intervention — Doulas trained in the DONA training, and the PMAD-focused training will provide care to perinatal people.
• Behavioral: Standard Doula Care — Doulas trained in the DONA training will provide care to perinatal people.

Primary Outcomes

• The Childbirth Self-Efficacy Inventory (CBSEI) (At study enrollment)
• Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 1 month postpartum (1-month postpartum)
• Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 3 months postpartum (At 3-months)
• Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 6 months postpartum (At 6-months postpartum.)
• The General Self-Efficacy Scale (SGSE) (At study enrollment)
• Change in the General Self-Efficacy Scale (SGSE) at 1-month postpartum (1-month postpartum)
• Change in the General Self-Efficacy Scale (SGSE) at 3-months postpartum (At 3-months postpartum)
• Change in the General Self-Efficacy Scale (SGSE) at 6-months postpartum (At 6-months postpartum.)

About This Study

This study investigates the effects of intentionally sequencing aerobic exercise immediately prior to cognitive behavioral therapy (CBT) to determine its effects on mechanisms of CBT (i.e., working alliance, behavioral activation). To assess the utility of this treatment augmentation, investigators will conduct a randomized controlled trial involving 100 adults with Major Depressive Disorder who will watch a nature documentary while either resting quietly ( 'CalmCBT') or exercising at a moderate intensity ('ActiveCBT') immediately prior to 8 weekly sessions of CBT.

Design

Interventions / Regimen

• Behavioral: Rest — 30 minutes of rest while watching a nature documentary before cognitive behavioral therapy
• Behavioral: Aerobic Activity — 30 minutes of aerobic activity before cognitive behavioral therapy, while watching the same nature documentary the CalmCBT group watches.

Primary Outcomes

• Working Alliance Inventory (WAI) - Bond subscale (data collected at each CBT session (weeks 1-8))
• Behavioral Activation for Depression Scale (BADS) (data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52)
• GRID Hamilton Rating Scale for Depression (GRID-HAMD) (baseline, post intervention visit (week 9), week 20, week 52)
• Patient Health Questionnaire-9 (PHQ-9) (data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52)

About This Study

This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e. quetiapine, lithium, lamotrigine, sertraline, or venlafaxine as monotherapy or adjunctive therapy, or bupropion adjunctive therapy). The active placebo is a substance that looks identical to the study medication but contains less therapeutic ingredients, and thus is less capable of producing the transformative and meaningful aspects of psychedelic experience compared to the 25 mg dose. Participants will have a total of 11 study visits over a period of up to 16 weeks, which includes 5 therapy sessions from trained study therapists.

Design

Interventions / Regimen

• Drug: psilocybin (25 mg) — Single-dose psilocybin (25 mg)-assisted therapy (PAT)
• Drug: psilocybin 1mg micro-dose — Single dose active placebo psilocybin-assisted therapy

Primary Outcomes

• Change in depressive symptoms (Baseline to Week 3)