Depression Clinical Trial
— TE-DSPOfficial title:
Tele-education in Patients With a Moderate Depressive Episode in Primary Care
Verified date | January 2024 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Presenting a depressive episode of moderate intensity according to the Diagnostic and Statistical Manual (DSM)-V - With a prescription for an antidepressant started less than 2 months before inclusion in the trial. - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Toulouse | Toulouse | Occitanie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evolution of depressive symptoms | Evolution of PHQ-9 depressive symptoms:
This will be carried out by comparing the differences in scores on the PHQ-9 scale at inclusion and at 6 months. The Patient Health Questionnaire-9 (PHQ-9) is a validated tool for assessing the severity of depressive disorder. The PHQ9 is a self-report screening tool. It contributes to the overall assessment of the patient and to monitoring his or her progress. The PHQ9 has been widely used and validated in primary care. It comprises nine items and respondents are asked to rate their experience of nine common symptoms of depression over the past two weeks. It is a 4-point rating scale where 0 indicates "not at all" and 3 "always". No depression: score from 0 to 4, Mild depression: score from 5 to 9, Moderate depression: score from 10 to 14, Moderately severe depression: score from 15 to 19 Severe depression: score from 20 to 27. |
6 months post inclusion | |
Primary | 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 | Effectiveness of the tele-education | Effectiveness of the tele-education programme compared with usual care on :
1) Changes in feelings of self-efficacy using a scale of feelings of self-efficacy at inclusion and at 3 months: The investigators will use the General Self-Efficacy Scale (GSE). Each statement is scored from 1 to 4: "not at all true", "barely true", "moderately true" and "totally true". The scale contains ten items. This self-questionnaire will be completed by the patient via the digital platform at inclusion and 3 months post inclusion. |
3 months post inclusion | |
Secondary | Effectiveness of the tele-education | Effectiveness of the tele-education programme compared with usual care on :
2) Changes in barriers to treatment using the Barriers to Care Evaluation (BACE) scale at inclusion and 3 months: The BACE-V3 scale is a self-administered questionnaire on barriers to access to care. It presents patients with possible barriers that may have prevented, delayed or discouraged them from seeking or pursuing professional care for a mental health problem. The help provided by a professional may be that of the GP, health staff (nurse, social worker, etc.), a psychiatrist, a counsellor, a psychologist or a psychotherapist. Patients are offered 4 response options for each of the 30 items, marked from 0 to 3: "not at all"; "a little"; "moderately"; "a lot". |
3 months post inclusion |
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