DepressionTE-DSPNCT06014125
Paramedical Tele-education on Moderate Depressive Episodes
A study testing psychoeducative program in people with Depression and Depression Moderate, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depression Moderate
- What is being tested?
- psychoeducative program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Toulouse
Toulouse, Occitanie, 31000
MARION LASSERRE, NURSE, 05 61 77 60 41, lasserre.ma@chu-toulouse.fr
SOPHIE PREBOIS, MD, prebois.s@chu-toulouse.fr
About this study
Official title: Tele-education in Patients With a Moderate Depressive Episode in Primary Care
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.
Read more
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.
Read the detailed 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.
- Conditions
- Depression, Depression Moderate
- Being tested
- psychoeducative program
- Keywords
- psychoeducation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducative programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post inclusion
Secondary outcomes (2)
Effectiveness of the tele-education
Effectiveness of the tele-education programme compared with usual care on :
- 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.
Measured: 3 months post inclusion
Effectiveness of the tele-education
Effectiveness of the tele-education programme compared with usual care on :
- 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".
Measured: 3 months post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start25 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centered randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion LASSERRE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014125
- Sponsor's protocol ID
- RC31/22/0262
- Acronym
- TE-DSP
- Status last verified
- May 2026
- First submitted
- 22 Aug 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-education in Patients With a Moderate Depressive Episode in Primary Care
- ClinicalTrials.gov ID
- NCT06014125
- Acronym / sponsor ID
- TE-DSP / RC31/22/0262
- Conditions
- Depression, Depression Moderate
- Keywords
- psychoeducation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centered randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| psychoeducation program group | Experimental | Other: psychoeducative programIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychoeducative programThe 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. | Other | psychoeducation program group |
Primary outcome
medication adherence
Time frame: 6 months post inclusion
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.
2 secondary outcomes
Effectiveness of the tele-education
Time frame: 3 months post inclusion
Effectiveness of the tele-education
Time frame: 3 months post inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marion LASSERRE principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducative program in people with Depression and Depression Moderate, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion LASSERRE, NURSE (05 61 77 60 41, LASSERRE.M@CHU-TOULOUSE.FR), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication adherence (time frame: 6 months post inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.