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About This Study

TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and Romania

Design

Primary Outcomes

• Depressive symptoms severity (MADRS) (At 24 weeks from treatment)

About This Study

This project will study the effect of the TAG TEAM group CBT program on the mental health of trans and gender diverse adolescents. TAG TEAM was co-designed by researchers and clinicians with a group of trans and gender diverse young people to help trans and gender diverse adolescents understand and cope with minority stress. Minority stress includes experiences like discrimination and rejection. TAG TEAM focuses on learning and practicing skills to support mental health and wellbeing. It also includes group discussions and activities with other trans and gender diverse young people. TAG TEAM groups are run by a psychologist and a trans peer facilitator. A trans peer facilitator is a trans and gender diverse person who is there to share their experience of being trans and to support participants in the group sessions.

Design

Interventions / Regimen

• Behavioral: Trans Adolescent Group ThErapy for Alleviating Minority stress — The intervention, Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM), is a group Cognitive Behavioural Therapy (CBT) program, originally developed using co-design methodology with trans and gender diverse young people. The 6 weekly, 2-hour session TAG TEAM program aims to improve mental health and wellbeing using evidence-based cognitive and behavioural strategies to target minority stressors discrimination and internalised stigma and facilitating community connection and pride. The intervention will be delivered by a psychologist facilitator and peer facilitator, who will both be trained and supervised by clinical psychologists, to groups of 8 participants from the same stratum.

Primary Outcomes

• Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y) (Measured at baseline (week 0) and 6 weeks after enrolment.)

About This Study

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing facility residents and their primary support person. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. The researchers will compare the InSTILL program to minimally enhanced usual care. Participants will be randomly assigned to receive either the InSTILL program or minimally enhanced usual care. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

Design

Interventions / Regimen

• Behavioral: Interventions for Stressful Transitions in Later Life — The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents and their care partners experiencing elevated levels of psychological distress. The intervention is designed to improve life management skills, emotion regulation skills, and dyadic coping skills with the goal of reducing depression symptoms among both dyad members (i.e., resident and care partner).

Primary Outcomes

• Treatment Credibility (peri-intervention)
• Client Satisfaction Questionnaire (immediately after the intervention)
• Feasibility of Recruitment (baseline, pre-intervention)
• Feasibility of Data Collection (1 month follow-up)
• Treatment Adherence (immediately after the intervention)
• Clinician Fidelity (immediately after the intervention)
• Adverse Events (1 month follow-up)
• Treatment Acceptability Survey (immediately after the intervention)

About This Study

The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents. The researchers will pair theatrical improvisation exercises with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a social craft group on reducing elevated levels of anxiety and depression.

Design

Interventions / Regimen

• Behavioral: Improvisation + Wellness — Theatrical improvisation exercises, the theatrical art of performance and storytelling without a script, will be combined with wellness techniques
• Behavioral: Improvisation — Theatrical improvisation exercises (the theatrical art of performance and storytelling without a script) will be completed in this arm. These exercises will be fairly similar to that from the improvisation + wellness but without the wellness techniques.
• Behavioral: Social Craft — Participants assigned to the Social Craft group will engage in arts and crafts projects and activities

Primary Outcomes

• Child Anxiety and Depression (based on Parent Report) (Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group)
• Child Anxiety and Depression (based on youth report) (Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group)
• Cognitive Behavioral Technique (CBT) Skill Knowledge (Baseline, after 9 weeks of the group curriculum, and 3 months post-group)
• Cognitive Behavioral Technique (CBT) Skills Use (Baseline, after 9 weeks of the group curriculum, and 3 months post-group)

About This Study

The R33 will be a randomized controlled trial to replicate changes in the targets (unproductive processing, avoidance, reward deficits) from the R61 phase in a larger sample of 135 participants who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, this study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle Relaxation (PMR). In the R33 phase, the investigators will examine changes in target mechanisms predicting improvements in PTSD and depressive symptoms, as well as feasibility and acceptability. Patients will receive 6 sessions of PATH or PMR (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 3, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.

Design

Interventions / Regimen

• Behavioral: Positive Processes and Transition to Health — See arm/group description for details regarding this intervention
• Behavioral: Progressive Muscle Relaxation — See arm/group description for details regarding this intervention

Primary Outcomes

• Affective Updating Task (Change from baseline score at 6 weeks (immediately post treatment))
• Idiographic Behavioral Approach Task (Change from baseline score at 6 weeks (immediately post treatment))
• Probabilistic Reward Task (Change from baseline score at 6 weeks (immediately post treatment))

About This Study

Major Depressive Disorder (MDD) is a chronic disease characterized by a high prevalence, low cure rate, and significant disability. Globally, depression is recognized as the leading cause of illness and disability among children and adolescents. Bright light therapy (BLT) has been established as an effective treatment for seasonal affective disorder and has demonstrated considerable efficacy in adult patients with MDD. However, its application in adolescent patients with MDD remains largely unexplored. The aim of this clinical trial is to evaluate the clinical efficacy, onset time, safety, and applicability of BLT in adolescents with MDD and to explore the potential neural mechanisms by which BLT enhances emotional and cognitive function in this population. This is a multicenter, randomized, controlled, double-blind study. It will involve adolescents aged 13 to 17 who are either untreated or have been stable on medication for at least one week. Adolescents with MDD will be randomly assigned to one of three groups: a high-intensity bright white light intervention group, a medium-intensity bright white light intervention group, and a placebo control group receiving dim red light. Each group will undergo four weeks of light exposure, six days per week, for 40 minutes daily between 6:30 and 10:00 AM. During the light exposure period, follow-up assessments will be conducted every weekend, and participants will be followed for two weeks after the completion of light exposure.The primary outcome will be the change in total scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17) from baseline to week 4. Secondary outcomes will include response and remission rates, time to onset, maintenance of efficacy, self-reported depressive symptoms, sleep quality, cognitive function, anxiety, irritability, suicidal ideation, non-suicidal self-injury, self-efficacy, and the overall safety profile of BLT. Additionally, the study will include healthy adolescent controls and collect functional Near-Infrared Spectroscopy (fNIRS) from both the adolescent participants with major depressive disorder and the healthy controls at baseline. The fNIRS and MRI data will also be collected from the adolescent participants with MDD at the end of the intervention, in order to investigate the potential neural mechanisms by which light therapy alleviates depressive symptoms in adolescents.

Design

Interventions / Regimen

• Device: Bright light therapy（High light intensity） — In this study, we will utilize the optocoupler-controllable light source, a product jointly developed by the School of Physics at Peking University and Peking University Sixth Hospital, which granted a national patent in China, for the purpose of intervention. Participants randomly assigned to the high light density intervention group will receive bright white light therapy interventions with light intensities of 10000 lux, and the main wavelength of light source is 476.4nm. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.
• Device: Bright light therapy（Low light intensity） — In this study, we will utilize the optocoupler-controllable light source, a product jointly developed by the School of Physics at Peking University and Peking University Sixth Hospital, which granted a national patent in China, for the purpose of intervention. Participants randomly assigned to the low light density intervention group will receive bright white light therapy interventions with light intensities of 5,000 lux,and the main wavelength of light source is 476.4nm. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.
• Device: Dim red light placebo-controlled intervention — In this study, participants randomly assigned to the placebo-controlled group will receive dim red light therapy interventions with light intensities of 100 lux, and the main wavelength of light source is 690.4nm. The placebo-controlled intervention plan is to receive 40 minutes of red light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.

Primary Outcomes

• Hamilton Depression Rating Scale-17(HAMD-17) (baseline，7 days after the intervention begin，14 days after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished)

About This Study

Major depressive disorder (MDD) is characterized by a cognitive triad of negative beliefs about oneself, the future and the world. For example, depressed patients hold persistently negative expectations about the future, despite contradictory evidence, and these strong negative beliefs are thought to play an important role in the maintenance of depressive symptoms and potentially in treatment resistance. Indeed, one out of three patients with major depressive disorder does not respond to conventional, monoaminergic treatments, which has led to the concept of treatment resistant depression (TRD). It is unknown how the brain encodes the strong negative beliefs that are insensitive to positive disconfirming information in TRD patients, and how these neural underpinnings of maladaptive belief updating are altered by antidepressant treatment. The principal objective of this study is to gain insight into the brain mechanisms of belief updating about the future in TRD patients before and after starting ketamine treatment. The results of this study are expected to provide a better understanding of the neurocognitive mechanisms of belief-updating in depressed patients, and how these mechanisms contribute to clinical improvement following ketamine antidepressant treatment.

Design

Interventions / Regimen

• Other: functional magnetic resonance imaging — Patients treated with ketamine antidepressants will be tested with fMRI before or 24h after a single ketamine infusion administered in the clinical setting.

Primary Outcomes

• Blood oxygenation level dependant (BOLD) signal (7 days)

About This Study

The purpose of this 8-week, double-blind, placebo-controlled, study is to explore new treatment options for people with depression who have high inflammation and anhedonia. Seventy male and female participants with depression, between 25-55 years of age, with higher levels of inflammation and anhedonia will be randomized to receive L-DOPA or matched placebo over 8 weeks. Participants will complete lab tests, medical and psychiatric assessments, motivation and motor tasks, and MRI scans as part of the study. The total length of participation is approximately 10 to 12 weeks.

Design

Interventions / Regimen

• Drug: Carbidopa Levodopa — Patients will receive between one and three tablets per day of 150 mg L-DOPA (administered with 37.5 mg carbidopa) to achieve doses ranging from 150 to 450 mg/day.
• Drug: Placebo — A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive between one and three placebo tablets per day matching the Carbidopa Levodopa tablet.

Primary Outcomes

• Change in depressive symptom severity measured by Hamilton Depression Rating Scale (HAM-D) (Baseline, weeks 1-4 post-intervention, weeks 5-8 post-intervention)

About This Study

The present study will assess the effects of a four-week digitally delivered intervention on physical activity and depressive symptoms among adults experiencing at least moderate depressive symptoms. The main questions this research aims to answer are: * Does a digitally-delivered intervention increase physical activity levels? * Does a digitally-delivered intervention reduce symptoms of depression? Researchers will compare an intervention promoting physical activity to a passive control (does not receive the intervention) group to see if the intervention reduces depressive symptoms and increases physical activity levels. Participants will: * Visit the laboratory at two separate time points before group assignment, separated by one week of physical activity monitoring * Be randomly assigned to complete four weeks of a digital intervention prompting engagement in physical activity or have their mental health symptoms monitored over four weeks (i.e., passive control group) * Visit the laboratory at two separate time points after the intervention, separated by one week of physical activity monitoring

Design

Interventions / Regimen

• Behavioral: Digital Physical Activity — The Pathverse mobile application platform will be downloaded on each participant's smartphone. Participants will be guided on how to download and use the application, as well as how to interact with the application during the intervention period. Participants will choose approximately five types of physical activity they enjoy before the intervention and will be prompted to complete these physical activities throughout the intervention. Participants will also self-report the duration and type of physical activity performed each day of the intervention.

Primary Outcomes

• Depressive Symptoms (pre-intervention, at the two-week time point during the intervention, and immediately after the intervention)
• Moderate-to-vigorous physical activity (pre-intervention and immediately after the intervention)

About This Study

The goal of this observational study is to create a single macro registry system with data collection on common clinical features, grouping the different rare diseases (RD). Moreover, the specific goals are to generate an alert system for possible cases of RD with data from the electronic medical record, to describe the occurrence of RD in the evaluated population, to characterize the population, to describe patterns of diagnosis and treatment of RD present at the time, and to explore patient-reported outcomes.

Design

Primary Outcomes

• Overall Survival Rate (From date of enrollment/ diagnosis until the date of death/ last follow up, assessed up to 5 years.)
• Mortality Rate (From date of enrollment/ diagnosis until the date of death, assessed up to 5 years.)
• Time to First Treatment (From date of diagnosis until the initiation of first treatment, assessed up to 12 months.)
• Demographic and Epidemiologic Profile (At baseline, assessed at the time of enrollment.)
• Clinical Characteristics and Disease Progression (From date of enrollment until the end of the study, assessed up to 5 years.)
• Treatment Modalities Received (From the initiation of first treatment until the last recorded intervention, assessed up to 5 years.)
• Treatment Response (From the initiation of treatment until documented disease progression or treatment cessation, assessed up to 5 years.)
• Incidence of Treatment-Related Adverse Events (From the initiation of treatment until 12 months after the last dose, assessed up to 5 years.)

About This Study

Hypertensive disorders of pregnancy are associated with endothelial dysfunction and increased maternal and fetal morbidity. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their relationship with blood pressure and endothelial function during pregnancy remains incompletely understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive pregnant women and pregnant women with hypertensive disorders of pregnancy. The study will also investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and circulating biomarkers of endothelial activation. The findings may improve understanding of endothelial injury during pregnancy and support the development of non-invasive biomarkers for early detection and monitoring of hypertensive disorders of pregnancy.

Design

Primary Outcomes

• Plasma endothelial extracellular vesicle concentration (Baseline)

About This Study

Registry Data from PH-patients in Switzerland, who have given consent to records for research purposes.

Design

Primary Outcomes

• 6-minute walking distance (within the study duration e.g. up to 10 years)