Paramedical Tele-education on Moderate Depressive Episodes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
psychoeducative program
Other interventionThe 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: psychoeducation program groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
6 months post inclusionSecondary outcomes
1
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.
Time frame
3 months post inclusion2
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".
Time frame
3 months post inclusionOther outcomes
1
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.
Time frame
6 months post inclusionSponsors and contacts
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Source ClinicalTrials.gov