Clinical Research Directory

Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers

This single-site prospective observational study aims to validate wearable-derived circadian and behavioral rhythm biomarkers using continuous core body temperature and raw accelerometry measurements and to explore longitudinal changes in circadian and rest-activity rhythms in psychiatric inpatients. The study consists of two complementary substudies. Study 1 will enroll 150 outpatients and community participants, including 75 patients with major depressive disorder or bipolar I/II disorder and 75 healthy controls. Participants will simultaneously wear a CALERAResearch core body temperature sensor and a Fitbit Charge 6 for approximately 7 days. Agreement between Fitbit-derived circadian and sleep/activity rhythm features and CALERAResearch-derived core body temperature and raw accelerometry markers will be evaluated. A subset of 50 participants will undergo a second measurement at least 1 month later to assess test-retest reliability. Study 2 will enroll 50 psychiatric inpatients irrespective of final diagnosis. Participants will continuously wear CALERAResearch and Fitbit devices from shortly after admission through the inpatient observation period, with CALERAResearch sensors replaced approximately every 5-7 days. Longitudinal changes in core body temperature rhythms, rest-activity rhythms, and physiological-behavioral rhythm alignment will be examined in relation to changes in psychiatric symptoms.

A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness

Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.

Recovery in Telling Life Stories

This project tests the Recovery In Telling Life Stories (RETELL) intervention, aimed at supporting personal recovery in people with severe mental illness (SMI). While many of those with SMI experience symptom control, their quality of life often remains low due to social loss, negative self-perceptions, and identity-related challenges not addressed by standard treatments. Through a process of narrative repair, the RETELL intervention helps participants explore the personal consequences of mental illness while supporting the enhancement of narratives that strengthen identity and foster well-being. The intervention is delivered across 8-12 sessions and will be assessed for feasibility of both the intervention and study procedures. We will also explore its preliminary impact on recovery, quality of life, symptoms, functioning, self-stigma, and personality, using a multiple single-case A-B-A design. We expect the intervention and study procedures to show acceptable feasibility. We further hypothesize that participants' scores on recovery and well-being will be low at baseline, improve during the intervention, and remain higher after the intervention ends and at 3-month follow-up. This study will provide a foundation for future randomized controlled trials.

Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group

Bipolar disorder is a condition characterized by succession of episodes- manic, hypomanic, and depressive episodes. Major risks factors of relapses are poor compliance, sleep disorder, and toxics consumption. The aims of psychoeducation programs are to increase compliance and knowledge about bipolar disorder. Serious game are supposed, in bipolar disorder, to strengthen the efficacy of psychoeducation programs. Bipolife® is a serious game which purpose is to help bipolar patients to deal with their conditions, through 3 mains messages : to pursue the treatment, to have daily routine and to request the psychiatrist in case of relapse. This is a multicentric randomized controlled study with two harms parallels. After a classic psychoeducation group program, patients are randomized in two groups : interventional group and control group with treatment as usual. The main objective is to evaluate the observance in the two groups. The other objectives are to evaluate daily routine, global functioning, and access to health care. Evaluations are realized at one and four months after inclusion visit. Acceptability and satisfaction about the serious game Bipolife® will be assessed in the interventional group.

Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions

This is a research study looking at whether the way people speak can help predict how well they'll respond to certain mental health treatments. The Main Goal: The researchers want to see if computer analysis of a person's speech patterns can predict whether they'll respond well to two specific treatments: TMS (Transcranial Magnetic Stimulation) and Spravato (a nasal spray medication). They're focusing on people with depression, bipolar disorder, OCD, anxiety, and PTSD. How It Works: 200 people with these conditions will participate in the study.Participants will record themselves speaking for about 12 minutes, responding to six different prompts.They'll do these recordings before treatment starts, daily during treatment, right after treatment ends, and again four weeks later. Doctors will track how well people are doing using various questionnaires and rating scales The researchers will look for connections between speech patterns and treatment success. The study will last 12 months. What Makes Someone a "Treatment Success": The study considers treatment successful if a person's symptoms improve significantly (specifically, a 2-point or greater reduction on a clinical rating scale (called Clinical Global Impression) and stays improved during the follow-up period (4-weeks). Why This Matters: If successful, this research could lead to a simple, non-invasive way to help doctors predict which treatments might work best for different patients. This could help people get the most effective treatment more quickly and help healthcare providers use their resources more efficiently. Safety Consideration The researchers will also check whether doing the speech assessments causes any distress to participants, making sure the evaluation process itself is safe and comfortable.

MonPsy&Moi: A Digital Platform for Collecting Patient-Reported Experience and Outcome Measures in Psychiatry

Mental health disorders, with a 30% annual prevalence rate, are a leading cause of disability and reduced life expectancy. Despite their impact, patient-reported experience measures (PREMs) and outcome measures (PROMs) are underutilized in psychiatry. MonPsy\&Moi®, a digital platform funded by ATIH and DGOS, addresses this gap by providing a user-friendly tool to assess patient experiences and outcomes in real-time, aiming to improve the quality of psychiatric care across France. The study consists of two stages: Stage 1 (No Feedback): MonPsy\&Moi® is deployed across 12 psychiatric facilities, collecting patient data without feedback to clinicians. Objectives include assessing implementation feasibility, validating adaptive questionnaires (PREMIUM), and identifying predictors of patient outcomes, such as relapse and healthcare utilization. Stage 2 (With Feedback): Focuses on patients with severe mental illnesses (schizophrenia, bipolar disorders, and major depressive disorders). This stage evaluates the impact of providing PREMs/PROMs feedback to clinicians on relapse rates, healthcare costs, and overall patient outcomes. MonPsy\&Moi® uses adaptive questionnaires tailored to psychiatric care, covering key domains such as dignity, information, interpersonal relationships, care environment, and treatment. It also evaluates health-related quality of life, including psychological well-being, autonomy, self-esteem, and social relationships. The platform integrates with national healthcare databases (SNDS) to enhance data analysis and predict patient trajectories. The study will involve over 22,000 participants in Stage 1 and 1,100 participants in Stage 2, using a quasi-experimental design to compare feedback and non-feedback strategies. Results aim to demonstrate the feasibility, acceptability, and efficacy of MonPsy\&Moi® in improving mental health outcomes and guiding national psychiatric care policies. By empowering patients and clinicians with actionable insights, MonPsy\&Moi® aspires to set a new standard for patient-centered mental healthcare in real-world settings

Effects of Lurasidone on Left Ventricle Systolic Functions

The goal of our study to learn if lurasidone molecule which is used on patients with schizophrenia or bipolar disorder has any cardiotoxic effect.