Clinical Research Directory

Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment

The goal of this observational study is to learn if a non-contact facial scan using artificial intelligence (AI) can be used to check health status in adults living in urban areas such as Jakarta. The facial scan uses a method called remote photoplethysmography (rPPG), which measures small changes in blood flow from the face using a camera. The main questions this study aims to answer are: 1. How close are the results from the facial scan to standard medical measurements, such as heart rate, breathing rate, blood pressure, and oxygen levels? 2. Can the facial scan estimate other health indicators, such as blood sugar, lipid profile, HbA1c, and hemoglobin levels? 3. Is there a relationship between the facial scan results and mental health, such as stress, anxiety, and depression? Participants will take part in several simple and mostly non-invasive procedures: 1. Answer questionnaires about their mental health and daily habits 2. Have basic health checks, such as blood pressure, heart rate, and body measurements 3. Provide a blood sample for laboratory testing 4. Complete a facial scan using a camera for about 1 to 3 minutes Researchers will compare the results from the facial scan with standard clinical and laboratory tests to see how well the technology works. This study may help develop a simple and accessible screening tool that can be used for early detection of health risks. It may also support the use of digital health and telemedicine in community and clinical settings.

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.

Aromatherapy for Mental Health Promotion in IVF Patients

The experience of infertility can cause significant emotional instability, especially for patients awaiting In Vitro Fertilization (IVF) treatment, generating anxiety, stress, and depressive symptoms. This study is a randomized clinical trial assessing the effectiveness of aromatherapy in improving mental health and quality of life in women undergoing infertility treatment. 120 participants will be randomized into three groups (Intervention, Placebo, and Control). The intervention involves the inhalation of true lavender essential oil (Lavandula angustifolia) for four weeks.

Transcranial Electrical Stimulation for Comorbid Depression and Chronic Pain

This clinical trial aims to investigate a novel non-pharmacological intervention, transcranial electrical stimulation (tES), for the treatment of comorbid depression and chronic pain. The primary objectives are to optimize neurostimulation parameters through a multicenter randomized controlled design and to elucidate the underlying neural circuit-immune interaction mechanisms of this comorbidity. Participants with comorbid depression and chronic pain will be randomly assigned to receive one of four interventions: (1) anodal tDCS unilateral hemispheric concurrent dual-site stimulation (a-tDCS UHCDS) targeting the left DLPFC and M1; (2) single-target anodal tDCS over the left DLPFC; (3) 40 Hz gamma transcranial alternating current stimulation (tACS); or (4) sham stimulation. The intervention period will last for 2 weeks, followed by a series of post-treatment follow-up assessments. Researchers will compare the changes in depression severity (e.g., assessed by HAMD-17) and pain intensity (e.g., NRS, BPI) across groups to evaluate the efficacy. Secondary outcomes include pain perception, quantitative sensory testing (QST), fMRI, MEG, metabolic markers, neurotransmitter and inflammatory biomarkers. This study aims to provide a precise, individualized therapeutic strategy, reduce reliance on pharmacotherapy, and promote the development of domestic high-end medical devices.

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression

The primary aim of this study is to evaluate the efficacy and tolerability of a combined Virtual Reality (VR)-based mindfulness intervention and pharmacological treatment compared with pharmacological treatment alone in reducing depressive symptoms in patients with Treatment-Resistant Depression (TRD). Secondary questions this study aims to address include: 1. Does the combined intervention lead to changes in inflammatory blood parameters compared with pharmacological treatment alone? 2. Does the addition of a VR-based mindfulness intervention prolong remission of depressive symptoms six months after treatment completion? 3. Is the combined treatment with mindfulness and esketamine well-tolerated, and how does its adverse effect profile compare with esketamine treatment alone? 4. Is there an association between changes in mindfulness trait levels, assessed using the FFMQ-SF, and reductions in depressive symptom severity? Participants will be recruited from a Treatment-Resistant Depression Programme and randomly assigned to receive either VR-based mindfulness intervention in addition to treatment as usual or treatment as usual alone. The mindfulness intervention will last one month and include a total of 8 sessions. All participants will undergo comprehensive assessments at baseline and at predefined follow-up time points to evaluate clinical outcomes, inflammatory markers, tolerability, and remission duration.

Lonely in Depression

The goal of this prospective study is to better understand the link between loneliness and depression in the inpatient psychiatric treatment of depression. It aims to answer: Do lonely and not lonely persons benefit the same way from inpatient depression treatment? Is loneliness a clinical relevant factor in inpatient treatment of depression? What are the underlying biopsychosocial mechanisms? Participants will be asked to do some * self-report questionnaires * clinical interview * biosampling (blood, saliva, stool) at three main measurement timepoints (1. begin of inpatient treatment, 2. day of discharge, 3. three months after discharge).

GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression

The goal of this clinical trial is to learn whether the dietary supplement GynMDD, when taken as an add-on to supportive psychotherapy, can improve symptoms of mild to moderate depression in adults aged 18 to 65. The main questions it aims to answer are: Does adding GynMDD to supportive psychotherapy lead to a greater reduction in depressive symptoms (measured by the MADRS scale) compared with supportive psychotherapy plus placebo? Does the supplement also improve digestive well-being and influence gut microbiota profiles over the course of treatment? Researchers will compare patients receiving supportive psychotherapy + GynMDD to those receiving supportive psychotherapy + placebo to see if GynMDD provides additional benefits beyond standard care. Participants will: * Attend regular appointments with their general practitioner * Complete one supportive psychotherapy session per week for 8 weeks * Take a daily dose of GynMDD or placebo * Complete weekly self-assessment questionnaires on mood, digestive symptoms, and any side effects via a mobile app * Provide two stool samples (at the start and end of the study) for microbiota analysis

General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients

In Belgium, many adults who have suffered from depression keep using antidepressants on a daily basis for years afterwards, sometimes longer than guidelines recommend. Yet for some people who have been feeling well for a long time, this is no longer necessary, while the continued use of antidepressants can lead to side effects and causes additional costs for the healthcare system. However, reducing the doses of antidepressants or stopping altogether is not always easy. Some patients are afraid that their depression will return, and GPs and pharmacists often find the subject difficult to broach. This is why the GPS-AD study is investigating a new approach in which GPs and pharmacists work more closely together to provide better support to patients. First, the GP invites patients who have been taking antidepressants for a long time for a consultation. Together, they discuss whether tapering of the medication is reasonable and feasible. If they agree to stop the treatment, the GP draws up a tapering plan tailored to the patient. The pharmacist helps monitor this process, offering advice and support to the patient while the doses are gradually reduced. The study will extend over a period of two years and will take place in GP practices throughout Belgium. The new approach based on closer collaboration between GPs and pharmacists will be compared to the current standard of care, to determine whether it helps more long-term users to stop taking antidepressants without experiencing a recurrence of depressive symptoms. The name of the study, GPS-AD (General Practitioner and Pharmacist Support for Antidepressant Discontinuation), refers to the collaboration between GPs and pharmacists in tapering of antidepressants, and also symbolises the support and guidance (the 'GPS') provided to patients and healthcare providers in assessing whether long-term use of antidepressants is still necessary.

Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth

Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems. Affecting an estimated 60-70% of detained Attention deficit hyperactivity disorderadolescents, it is a major driver of aggression, substance use, school failure, and later recidivism. Despite available treatments, managing emotional dysregulation in custody remains challenging, with youth often enduring high arousal, anger, and anxiety that persist into adulthood. Current popular therapies, including Cognitive Behavioral Therapy (CBT) and Dialectic Behavioral Therapy (DBT), often fall short in detention because they rely on verbal processing, require multiple scheduled sessions, and/or need highly trained staff. Other technologies, like biofeedback and neurostimulation techniques, are still under scrutiny for adolescents, given their higher-than-usual Adverse Events (AEs). This SoundHeal study aims to evaluate a sensory intervention using the Healpod, a distraction-free physical space where a participant sits, delivering sound, music, gentle vibrations, and ambient light. Following this is a brief expressive journaling exercise to compare any before, during and after experience changes from the sensory immersion. This prospective, single-center cohort study hypothesizes that these sessions will improve juveniles' ability to emotionally regulate, improve therapeutic alliance, mental health outcomes and build coping skills that can potentially help in long-term mental health and substance abuse treatment in JIY and beyond.

Electro-acupuncture for SCD With Depression

The goal of this clinical trial is to evaluate the efficacy and safety of electroacupuncture in treating adults with subjective cognitive decline accompanied by depression. The main objectives are to answer the following questions: 1. Can electroacupuncture improve cognitive function and depressive symptoms in individuals with subjective cognitive decline accompanied by depression? 2. Does electroacupuncture alleviate subjective cognitive decline with depression by modulating the amygdala-entorhinal circuit, and if so, what is the specific mechanism involved? Researchers will compare real electroacupuncture therapy with sham electroacupuncture therapy to determine whether real electroacupuncture can effectively improve symptoms in patients with subjective cognitive decline accompanied by depression. Additionally, multimodal magnetic resonance imaging (MRI) technology will be used to assess changes in the amygdala-entorhinal circuit following electroacupuncture intervention. Participants will: 1. Receive either real or sham electroacupuncture treatment once daily, 3-5 times per week, for a total treatment duration of 8 weeks. 2. Undergo cognitive function and depression assessments before and after treatment. 3. Complete multimodal cranial magnetic resonance imaging examinations before and after treatment.

Impact of Nut Consumption on Mental Health in Young Adults

Nuts have a high nutrient density, and numerous studies have reported their cardiometabolic benefits. Although observational studies in adults have indicated a potential link between nut consumption and improved mental health, there is still insufficient evidence from experimental studies to draw firm conclusions about this association.

The Effects of Chiropractic on Adults With Depression

The goal of this clinical trial is to evaluate the feasibility of the study design in preparation for a future clinical trial examining chiropractic care for adults with mild to moderate depression. We aim to determine whether the study procedures function as intended, including the ability to recruit, retain, and engage participants, as well as whether the intervention is implemented as planned. The main questions it aims to answer is: 1. Can sufficient eligible participants be enrolled within the planned timeframe? 2. Is there any retention of participant throughout the study duration and the factors contributing to ongoing participation? 3. Can participants adhere to pre-treatment instructions and protocols before their first check-up? 4. Can participants attend and complete all assessments and chiropractic sessions? 5. Can participants fulfill all required study activities without excessive burden? 6. Can chiropractors strictly follow chiropractic adjustments only, without offering any additional treatments? Researchers will compare adults with depression on the waitlist group to see if chiropractic care effects on adults with depression. Participants will * Perform resting state Electrocardiography (ECG) * Perform resting state Electroencephalography (EEG) * Perform Event-related potential (ERP) à Auditory and visual stimuli tests * Complete Patient Reported Outcomes (PROs) * COMPASS-31 * PROMIS-29 * PROMIS-Cog-8 * Perceived Stress Scale * Depression Short Form 8a * Complete Assessment of Acceptability * Complete Columbia Suicide Severity Rating Scale (C-SSRS) * Receive 6 weeks of chiropractic care treatment

Change in Social Media Use and Well-being Among College Students Receiving a Two-week Exercise or Mindfulness Intervention

The investigators will be randomizing 300 college student participants with high levels of social media use into either a 1) control condition (no intervention), a 2) mindfulness meditation cognitive intervention, or 3) a social media reduction + exercise replacement intervention. Participants complete intervention activities daily for two weeks. The investigators will collect self-report and behavioral measures of social media use and related psychological constructs at three time points: baseline, immediately after the intervention period, and one-week after the intervention period (three weeks from baseline).

Impact of Therapeutic Exercise Integrated With Psychotherapy and Education in Patients With Depression

The goal of this clinical trial is to evaluate whether a combined approach including therapeutic exercise, psychotherapy, and therapeutic education can improve depressive symptoms and quality of life in adults diagnosed with depression. The main questions it aims to answer are: Does a biobehavioral intervention that integrates exercise, psychotherapy, and education reduce depressive symptoms more effectively than psychotherapy alone? Does this combined approach improve quality of life, physical function, and sleep quality compared with standard psychological therapy? Researchers will compare the intervention group (therapeutic exercise + psychotherapy + education) to the control group (psychotherapy alone) to determine whether the integrated program provides greater improvements in mental health and well-being. Participants will: Complete an initial assessment including demographic data, physical tests, and validated questionnaires. Be randomly assigned to one of the two groups. If in the intervention group, take part in an 8-week telematic program consisting of graded activity, therapeutic exercise, and educational sessions. Undergo post-intervention assessments and a follow-up evaluation 12 weeks after the program ends. This study aims to provide evidence on whether combining therapeutic exercise and education with psychotherapy can enhance treatment outcomes and promote long-term adherence to physical activity in people with depression.

Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression

This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms

Link Between Reduction of Suicide Ideation by Esketamine in Add-On and Initial Levels of Psychological Pain and Anhedonia

This study is looking at how intranasal esketamine (a nasal spray) can help reduce suicidal thoughts in patients with severe depression who are experiencing suicidal thoughts. Suicidal depression is a type of depression where people have active thoughts of suicide, which can be harder to treat with regular antidepressants. In fact, some people continue to have suicidal thoughts even after taking antidepressants. Esketamine has already shown promise in helping reduce suicidal thoughts quickly-often within 24 hours-and these effects can last for up to 25 days. Researchers believe esketamine may work by improving mood-related symptoms like loss of pleasure (called anhedonia) and feelings of hopelessness, which are linked to suicidal thinking. They also think that psychological pain, or emotional distress, might play a role in how well esketamine helps reduce suicidal thoughts. The goal of this study is to better understand how esketamine works to improve suicidal thoughts and whether certain factors (like mood symptoms or emotional pain) can predict which patients will benefit the most from this treatment. This study uses data from two earlier clinical trials, called ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133), that tested intranasal esketamine in patients with depression and suicidal thoughts. All data from these studies are publicly available and can be accessed and analyzed through the YODA (Yale University Open Data Access) platform, a database of clinical trial data that is accessible to external researchers.

Mpata Yathu Trial for Young Women in Zambia

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 are often underserved in traditional healthcare systems. If successful, this model could be expanded to other churches or schools in Zambia and similar settings. The results will inform future large-scale evaluations and could help shape new strategies for addressing GBV, mental health, and HIV among youth in sub-Saharan Africa.

Organizational Strategies and Psychosocial Skills for Maintaining Physical Activity After a Depressive Episode: a 3-month Post-rehabilitation Study.

With nearly 280 million people affected worldwide (2022), the management of depression represents a major public health issue. The study titled "Organizational Strategies and Psychosocial Skills to Maintain Physical Activity after a Depressive Episode: A 3-Month Post-Rehabilitation Study" (AP\&Depression) fits within this context. Physical activity (PA) is now recognized as an effective complementary therapy to pharmacological and psychotherapeutic treatments, helping to regulate mood and reduce depressive symptoms. However, despite these proven benefits, individuals who have experienced a depressive episode often struggle to maintain regular physical activity once they leave the hospital setting. This study aims to identify the mechanisms that influence the continuation of PA after hospitalization by exploring organizational strategies, psychosocial skills, and individual determinants involved in this process. Depression is a debilitating illness characterized by persistent sadness, loss of interest, chronic fatigue, and impaired cognitive and physical abilities (DSM-5, 2013). Among the aggravating factors, sedentary behavior plays a key role, whereas PA is associated with a significant reduction in the risk of relapse. Yet, 67.8% of individuals with depression do not meet the recommended 150 minutes of weekly PA, and this figure rises to 85.7% when activity is measured objectively. This situation is explained by several barriers: lack of motivation, low self-efficacy, fluctuating mood disorders, social isolation, and limited access to exercise facilities. Conversely, certain factors facilitate the resumption of PA after a depressive episode, including structured support, the establishment of routines, social support, and therapeutic education. The study relies on a qualitative methodology using semi-structured interviews conducted with 15 patients who stayed at the Rehabilitation Center of the Clinique des Portes de l'Eure. Participants are selected according to the following criteria: aged over 18, medically diagnosed with a depressive episode, underwent rehabilitation, and completed an initial assessment at the Maison Sport Santé. They will be interviewed three months after discharge to explore their PA practices. Data will be analyzed using NVivo software, following the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. The analysis of transcripts will help identify the organizational strategies implemented, the psychosocial skills involved, and the individual determinants influencing the maintenance of regular PA. The expected results should highlight that patients adopt various strategies to maintain PA after hospitalization. Session planning, the gradual integration of PA into daily life, and the anticipation of obstacles are major levers for establishing a sustainable routine. In addition, psychosocial skills, such as stress management and interaction with a support network, emerge as essential elements for maintaining regular physical activity. However, several obstacles may be identified, including persistent fatigue, mood fluctuations, lack of organization, and social isolation. These findings underscore the importance of personalized support after rehabilitation, particularly through mechanisms such as Patient Therapeutic Education (PTE) or individualized follow-up in Maisons Sport Santé. The aim of this study is to shed light on the mechanisms that enable individuals who have experienced a depressive episode to autonomously maintain physical activity after hospitalization. This research seeks to provide concrete recommendations for improving support during and after hospitalization to enhance adherence to PA. The study's conclusions could contribute to the development of new therapeutic approaches aimed at improving patients' quality of life.

Effects of Mindfulness and Self-regulation Training on Anxiety, Depression, PTSD, and Leadership

The goal of this study is to measure the effects of Mindfulness-based Mind Fitness Training (MMFT) on anxiety, depression, post-traumatic stress disorder, sleep quality, and leadership.

Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression Disorder

The goal of this clinical trial is to learn if Five-Elements Music Therapy works to treat depression disorder. It will also learn about the mechanism of action of Five-Elements Music Therapy of Traditional Chinese Medicine (TCM) for depression disorder. The main questions it aims to answer is: Can Five-Elements Music Therapy, primarily using Gong-mode and Zhi-mode tones, improve Hamilton Depression Rating Scale (HAMD) scale scores in patients with depression disorder by regulating prefrontal cortex function? Researchers will compare customized five-element music 1 (featuring Gong-mode and Zhi-mode as the predominant tones) to customized five-element music 2 (featuring Shang-mode and Yu-mode as the predominant tones, with identical rhythm and pitch to music 1), while simultaneously observing electroencephalogram (EEG), eye movement, and pulse diagnostic data from a healthy control group, to see if customized five-element music 1 featuring Gong-mode and Zhi-mode as the predominant tones can significantly improve depressive states in patients with depressive disorder. Participants will: 1. Undergo Five-Element Music 1 or Five-Element Music 2 therapy twice daily for 4 weeks (28 days), with each session consisting of 30 minutes of music listening followed by 10 minutes of rest. 2. Concurrently receive antidepressant therapy with fluoxetine hydrochloride. 3. Undergo relevant examinations once every two weeks and record their levels of depression and anxiety (Hamilton Depression Rating Scale (HAMD) \& Hamilton Anxiety Rating Scale (HAMA)). 4. Undergo and record their post-intervention electroencephalogram (EEG), eye movement, and pulse characteristics after the 4-week period.