Clinical Research Directory

Remote Medical Monitoring of Patients With Depression

The goal of this clinical trial is to learn if ThIA Suivi, a digital tool for remote monitoring of patients, can improve the care of adults with depression who are followed by a psychiatrist. The main question it aims to answer is: \* Does using ThIA Suivi in addition to usual psychiatric care increase the proportion of patients whose depression symptoms have clearly improved after 3 months, compared with usual care alone? (Improvement is measured with a questionnaire on depression symptoms, the PHQ-9, and is defined as a drop of at least 5 points from the starting score.) Researchers will compare patients who use ThIA Suivi with patients who receive usual care only, to see if ThIA Suivi leads to a greater improvement in symptoms. The researchers' hypothesis is that patients using ThIA Suivi will do better. \[ Participants will: * Continue to be followed by their psychiatrist as usual. * Use ThIA Suivi or will receive usual care only * Complete questionnaires about their symptoms at 3 months, 6 months and 12 months. * Be followed for 12 months. Why is this study needed? Depression is a common mental health condition. It causes lasting sadness, loss of interest in everyday activities, and low energy. About 280 million people worldwide live with depression. It affects daily life, work, and relationships, and it can come back: more than half of people who have one episode will have another. Depression is often treated with antidepressant medication. However, after 8 weeks of treatment, only about 1 in 3 people fully recovers. Side effects can appear before the benefits, which can make it hard to keep taking the medication. Close follow-up after treatment starts is therefore important. In practice, the first follow-up visit often happens late (a median of 27 days after the prescription in France). In addition, psychiatrists are not evenly spread across France, and most first antidepressant prescriptions are written by general practitioners. Digital tools may help patients and health professionals stay in contact between visits. In France, however, no remote monitoring tool for mental health is currently reimbursed by the national health insurance. ThIA Suivi was developed by ThIA Santé Mentale to fill this gap. It is meant to be used within a care pathway supervised by health professionals. The researchers hope that it will improve patients' care, help them stay on track with treatment, and reduce the risk of the depression coming back.

Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study

The goal of this feasibility study is to learn if the randomised controlled trial evaluating the Remote-delivery Balance in Everyday Life (rBEL) programme for adults younger than 55 years who have experienced a myocardial infarction (MI), is feasible. The objective is to examine the feasibility of the rBEL programme and the associated study procedures before a controlled evaluation of the programme. This is an uncontrolled, single-arm, pre-post treatment designed study. Participants of the target population will take part of the six session over 13 week programme. Feasibility will be evaluated against predefined feasibility criteria regarding study procedures and programme acceptability.

Drumming Groups for Parents of Autistic Children

This project aims to encourage a sense of belonging, community, and emotional support for parents of autistic children through a group drumming (music therapy) intervention.

Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence

The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI/AN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and/or PTSD symptoms (primary outcomes). Previous research with non-AI/AN women finds that ESD reduces depression and PTSD symptoms, but no research has examined ESD among AI/AN survivors despite calls from our tribal partners to implement ESD with AI/AN adult women survivors. The investigators have assembled an interdisciplinary expert team and Elders/Traditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.

Depressive Tendency and Counseling Outcomes in Thymoma-Associated MG

This study aimed to examine whether baseline depressive tendency independently predicts post-counseling clinical outcomes in patients with thymoma-associated MG. This single-group pre-post exploratory pilot study enrolled patients with thymoma-associated MG who received eight sessions of Gestalt-oriented psychological counseling. Depressive tendency was defined as a baseline Patient Health Question-naire-9 (PHQ-9) score ≥10. Clinical outcomes, including the Myasthenia Gravis Activities of Daily Living scale (MG-ADL), Myasthenia Gravis Quality of Life 15-item scale (MG-QoL15), and mental BMI (mBMI), were assessed before and after the intervention. Multivariable regression analyses were performed to evaluate whether baseline clinical severity independently predicted post-intervention outcomes after sequential adjustment for baseline scores, age, and sex.

Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression

This observational study investigates the use of Esketamine Intranasal Spray in patients with Treatment-Resistant Depression in Real-World Settings. The study aims to evaluate the clinical outcomes, including efficacy and safety, of esketamine treatment. It also explores predictors of treatment response, focusing on biological pathways such as genetics, neuroimaging, and psychophysical measures. Additionally, the study examines how esketamine impacts patients' life functioning, including social and occupational aspects. The goal is to better understand who benefits most from esketamine and how it affects daily life, to improve personalized care for patients with difficult-to-treat depression.

"Erectile Function After PCI in MI and Non-MI Patients"

The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.

Effectiveness of the DMHI and OPS Platform in Improving Participant QOL: a Randomised Controlled Trial.

RCT to evaluate the efficacy of a digital mental health intervention platform with open peer support in improving participant quality of life.

Evaluation of Dalia Solution For Depressed Patient

The goal of this superiority clinical investigation, prospective, multicenter, controlled, randomized, open-label is to evaluate the clinical impact of the Dalia medical telemonitoring device on the management of depressive patients. The main question it aims to answer is: the percentage of patients with clinically significant improvement at 3 months. A clinically significant improvement is defined as a decrease of at least 5 points from the initial PHQ-9 score AND/OR a PHQ-9 score lower than 15. The threshold of 5 points is the Minimal Clinically Important Difference (MCID) of the PHQ-9 scale