Paramedical Tele-education on Moderate Depressive Episodes

NCT06014125 | Recruiting

• 1 other identifier: RC31/22/0262
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Depression Moderate

Keywords

psychoeducation

Outcome Measures

Primary Outcomes (1)

• medication adherence

  The primary endpoint will be measured by the rate of maintenance on continuous antidepressant medication at 6 months after inclusion in the study. This maintenance rate will be measured using healthcare reimbursement data to reconstruct exposure to antidepressant medication at 6 months following inclusion in the study.

  6 months post inclusion

Secondary Outcomes (2)

• Effectiveness of the tele-education

  3 months post inclusion

• Effectiveness of the tele-education

  3 months post inclusion

Other Outcomes (1)

• Evolution of depressive symptoms

  6 months post inclusion

Study Arms (2)

psychoeducation program group

EXPERIMENTAL

In addition to the usual treatment, the experimental group will receive a tele-education programme on depression in 5 individual remote sessions. During these sessions, the symptoms of the illness will be discussed, as well as health and diet measures, the destigmatisation of the illness, mobilisation of family and friends, the various treatments for depression and, finally, an assessment of what has been learned, which will be sent to the general practitioner with the patient's agreement.

Other: psychoeducative program

control group

NO INTERVENTION

The control group will receive their usual care from their GP. An educational booklet on depression will be provided to patients at the start of the study.

Interventions

psychoeducative program OTHER

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. The second session will focus on personalised hygienic and dietary measures. 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.

psychoeducation program group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting a depressive episode of moderate intensity according to the Diagnostic and Statistical Manual (DSM)-V
• Whose state of health is compatible with follow-up by their GP (possibility of occasional advice from a psychiatrist).
• Have Internet access at home (computer) and are able to use the digital platform.

You may not qualify if:

• Patients who are unable to complete self-questionnaires (language barrier, etc.)
• Who have already undergone a psycho-education or therapeutic patient education programme regarding depression.
• Whose state of health requires follow-up by a psychiatrist

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Chu Toulouse

Toulouse, Occitanie, 31000, France

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Marion LASSERRE

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centered randomised controlled trial

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: January 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)