xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06014125</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/22/0262</org_study_id>
      <nct_id>NCT06014125</nct_id>
    </id_info>
    <brief_title>Paramedical Tele-education on Moderate Depressive Episodes</brief_title>
    <acronym>TE-DSP</acronym>
    <official_title>Tele-education in Patients With a Moderate Depressive Episode in Primary Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Considering that one out of five people may experience depression during the course of their&#xD;
        life, and that compliance to anti-depression medication is often not optimal.&#xD;
  &#xD;
        Psycho-educational interventions are recommended in international clinical practice&#xD;
        guidelines for the management of depression. They are the first step in the treatment&#xD;
        protocol.&#xD;
  &#xD;
        Psychoeducation in the treatment of depressive episodes has been shown to be an effective&#xD;
        intervention because it reduces depressive symptoms, the risk of relapse or recurrence and&#xD;
        improves adherence to treatment.&#xD;
  &#xD;
        In France, there are only one approved psycho-education programme, but it concerns a&#xD;
        population of patients under psychiatric care.&#xD;
  &#xD;
        No psycho-education programme has yet been carried out or evaluated in France on depressed&#xD;
        patients followed up in primary care by their General Practitioner.&#xD;
  &#xD;
        Recent changes in our healthcare practices, which have required adaptation to the pandemic&#xD;
        context, have led to the development of the use of telemedicine.&#xD;
  &#xD;
        This study aims to evaluate a new and 100% remote educational program adapted to patients&#xD;
        ongoing moderate depression and focused on medication adherence, economic gain and patients&#xD;
        and professional satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In addition to the usual standard care, recruited patients will benefit from either an&#xD;
        individual tele-education programme or standard care following the randomisation.&#xD;
  &#xD;
        The psycho-education programme is based on 3 dimensions: educational (nature of the&#xD;
        information and how it should be delivered), psychological (revelation of the diagnosis and&#xD;
        transmission of information in a personalised way), behavioural and cognitive (restoring the&#xD;
        skills and mobilising the resources of the subject in their daily functioning and in their&#xD;
        relationship with the disease (management of treatment and communication skills in&#xD;
        particular).&#xD;
  &#xD;
        A low number of sessions has been chosen, as it is more appropriate for this population,&#xD;
        whose disorders are not severe and who do not require specialist care. The emphasis was&#xD;
        placed on personalising the information, with one-to-one sessions.&#xD;
  &#xD;
        The tele-education program consists of 5 sessions and is designed to adapt to changes in&#xD;
        depressive symptoms over time. Each session will last an average of 60 minutes. They will be&#xD;
        scheduled every week for 5 weeks.&#xD;
  &#xD;
        The first session is devoted to educational diagnosis, with identification of the patient's&#xD;
        needs and any barriers to treatment, in order to personalise the information to be provided&#xD;
        about the programme.&#xD;
  &#xD;
        The second session will focus on personalised hygienic and dietary measures. This will&#xD;
        involve identifying sleep habits and leisure activities through behavioural analysis, and&#xD;
        then identifying coping strategies with the patient in order to identify habits that can help&#xD;
        combat depression.&#xD;
  &#xD;
        A third session will focus on identifying the symptoms of depression, with a particular focus&#xD;
        on suicidal ideation and the causes of depression. The role of family and friends will also&#xD;
        be discussed.&#xD;
  &#xD;
        A fourth session will be devoted to providing clear information on antidepressants, with&#xD;
        particular attention to the duration of treatment.&#xD;
  &#xD;
        The aim of the final session is to identify what has been learned and to clarify any&#xD;
        questions before drawing up a joint summary of the work done, which will be sent to the&#xD;
        patient's GP with his or her consent.&#xD;
  &#xD;
        The liaison note is drawn up by the nurse with the patient for the general practitioner,&#xD;
        focusing on: the patient's resources, in particular a personalised activity programme, and&#xD;
        the patient's entourage, the areas of weakness identified and the risks identified of&#xD;
        discontinuity in compliance.&#xD;
  &#xD;
        Patients in the control group will receive standard care as usual. An educational booklet on&#xD;
        depression, produced by the Institut National de Prévention et d'Education pour la Santé,&#xD;
        will be sent to them by email after randomisation. It covers the symptoms, treatments and&#xD;
        professionals to be consulted about depression. Patients will be able to consult this guide&#xD;
        whenever they wish, without restriction, throughout the study.&#xD;
  &#xD;
        Patients will usually be monitored by their GP, who may contact and refer them to the DSPP&#xD;
        for psychiatric advice at any time during the study. The GP remains the referent for the&#xD;
        patient's mental health care, with the support of the DSPP.&#xD;
  &#xD;
        All participants in the study (control and experimental groups) may also be monitored by a&#xD;
        psychologist, and will complete questionnaires.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Single-centered randomised controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>medication adherence</measure>
      <time_frame>6 months post inclusion</time_frame>
      <description>The primary endpoint will be measured by the rate of maintenance on continuous antidepressant medication at 6 months after inclusion in the study.&#xD;
  This maintenance rate will be measured using healthcare reimbursement data to reconstruct exposure to antidepressant medication at 6 months following inclusion in the study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effectiveness of the tele-education</measure>
      <time_frame>3 months post inclusion</time_frame>
      <description>Effectiveness of the tele-education programme compared with usual care on :&#xD;
  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: &quot;not at all true&quot;, &quot;barely true&quot;, &quot;moderately true&quot; and &quot;totally true&quot;. 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness of the tele-education</measure>
      <time_frame>3 months post inclusion</time_frame>
      <description>Effectiveness of the tele-education programme compared with usual care on :&#xD;
  2) Changes in barriers to treatment using the 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: &quot;not at all&quot;; &quot;a little&quot;; &quot;moderately&quot;; &quot;a lot&quot;.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Evolution of depressive symptoms</measure>
      <time_frame>6 months post inclusion</time_frame>
      <description>Evolution of PHQ-9 depressive symptoms:&#xD;
  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.&#xD;
  It comprises nine items and respondents are asked to rate their experience of nine common symptoms of depression over the past two weeks.&#xD;
  It is a 4-point rating scale where 0 indicates &quot;not at all&quot; and 3 &quot;always&quot;.&#xD;
  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.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">220</enrollment>
    <condition>Depression</condition>
    <condition>Depression Moderate</condition>
    <arm_group>
      <arm_group_label>psychoeducation program group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>psychoeducative program</intervention_name>
      <description>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.&#xD;
  The first session is devoted to educational diagnosis, with identification of the patient's needs and any barriers to treatment.&#xD;
  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.&#xD;
  A fourth session will be devoted to providing clear information on antidepressants, with particular attention to the duration of treatment.&#xD;
  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.</description>
      <arm_group_label>psychoeducation program group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presenting a depressive episode of moderate intensity according to the DSM-V&#xD;
  &#xD;
            -  With a prescription for an antidepressant started less than 2 months before inclusion&#xD;
               in the trial.&#xD;
  &#xD;
            -  Whose state of health is compatible with follow-up by their GP (possibility of&#xD;
               occasional advice from a psychiatrist).&#xD;
  &#xD;
            -  Have Internet access at home (computer) and are able to use the digital platform.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are unable to complete self-questionnaires (language barrier, etc.)&#xD;
  &#xD;
            -  Who have already undergone a psycho-education or therapeutic patient education&#xD;
               programme regarding depression.&#xD;
  &#xD;
            -  Whose state of health requires follow-up by a psychiatrist&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marion LASSERRE</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Chu Toulouse</name>
        <address>
          <city>Toulouse</city>
          <state>Occitanie</state>
          <zip>31000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>MARION LASSERRE, NURSE</last_name>
        <phone>05 61 77 60 41</phone>
        <email>lasserre.ma@chu-toulouse.fr</email>
      </contact>
      <contact_backup>
        <last_name>SOPHIE PREBOIS, MD</last_name>
        <email>prebois.s@chu-toulouse.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>psychoeducation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06014125
  org study id: RC31/22/0262
  nct id: NCT06014125
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Single-centered randomised controlled trial
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: medication adherence
  time frame: 6 months post inclusion
  description: 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.
  measure: Effectiveness of the tele-education
  time frame: 3 months post inclusion
  description: 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.
  measure: Effectiveness of the tele-education
  time frame: 3 months post inclusion
  description: Effectiveness of the tele-education programme compared with usual care on :
  2) Changes in barriers to treatment using the 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".
  measure: Evolution of depressive symptoms
  time frame: 6 months post inclusion
  description: 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.
  arm group label: psychoeducation program group
  arm group type: Experimental
  description: 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.
  arm group label: control group
  arm group type: No Intervention
  description: 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.
  intervention type: Other
  intervention name: psychoeducative program
  description: 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.
  arm group label: psychoeducation program group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marion LASSERRE
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  facility: 
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: No