Clinical Trials Logo

Clinical Trial Summary

Considering that one out of five people may experience depression during the course of their life, and that compliance to anti-depression medication is often not optimal. Psycho-educational interventions are recommended in international clinical practice guidelines for the management of depression. They are the first step in the treatment protocol. Psychoeducation in the treatment of depressive episodes has been shown to be an effective intervention because it reduces depressive symptoms, the risk of relapse or recurrence and improves adherence to treatment. In France, there are only one approved psycho-education programme, but it concerns a population of patients under psychiatric care. No psycho-education programme has yet been carried out or evaluated in France on depressed patients followed up in primary care by their General Practitioner. Recent changes in our healthcare practices, which have required adaptation to the pandemic context, have led to the development of the use of telemedicine. This study aims to evaluate a new and 100% remote educational program adapted to patients ongoing moderate depression and focused on medication adherence, economic gain and patients and professional satisfaction.


Clinical Trial Description

In addition to the usual standard care, recruited patients will benefit from either an individual tele-education programme or standard care following the randomisation. The psycho-education programme is based on 3 dimensions: educational (nature of the information and how it should be delivered), psychological (revelation of the diagnosis and transmission of information in a personalised way), behavioural and cognitive (restoring the skills and mobilising the resources of the subject in their daily functioning and in their relationship with the disease (management of treatment and communication skills in particular). A low number of sessions has been chosen, as it is more appropriate for this population, whose disorders are not severe and who do not require specialist care. The emphasis was placed on personalising the information, with one-to-one sessions. The tele-education program consists of 5 sessions and is designed to adapt to changes in depressive symptoms over time. Each session will last an average of 60 minutes. They will be scheduled every week for 5 weeks. The first session is devoted to educational diagnosis, with identification of the patient's needs and any barriers to treatment, in order to personalise the information to be provided about the programme. The second session will focus on personalised hygienic and dietary measures. This will involve identifying sleep habits and leisure activities through behavioural analysis, and then identifying coping strategies with the patient in order to identify habits that can help combat depression. A third session will focus on identifying the symptoms of depression, with a particular focus on suicidal ideation and the causes of depression. The role of family and friends will also be discussed. A fourth session will be devoted to providing clear information on antidepressants, with particular attention to the duration of treatment. The aim of the final session is to identify what has been learned and to clarify any questions before drawing up a joint summary of the work done, which will be sent to the patient's GP with his or her consent. The liaison note is drawn up by the nurse with the patient for the general practitioner, focusing on: the patient's resources, in particular a personalised activity programme, and the patient's entourage, the areas of weakness identified and the risks identified of discontinuity in compliance. Patients in the control group will receive standard care as usual. An educational booklet on depression, produced by the Institut National de Prévention et d'Education pour la Santé, will be sent to them by email after randomisation. It covers the symptoms, treatments and professionals to be consulted about depression. Patients will be able to consult this guide whenever they wish, without restriction, throughout the study. Patients will usually be monitored by their General Practioner (GP), who may contact and refer them to the DSPP for psychiatric advice at any time during the study. The GP remains the referent for the patient's mental health care, with the support of the DSPP. All participants in the study (control and experimental groups) may also be monitored by a psychologist, and will complete questionnaires. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06014125
Study type Interventional
Source University Hospital, Toulouse
Contact
Status Recruiting
Phase N/A
Start date January 25, 2024
Completion date December 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A