<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/NCT03000985</url>
  </required_header>
  <id_info>
    <org_study_id>PHRIP PSY EDUC 2013</org_study_id>
    <nct_id>NCT03000985</nct_id>
  </id_info>
  <brief_title>Evaluation of a Psychoeducation Program for Families Caregivers of Schizophrenic Patients : Randomized Study in Two Arms</brief_title>
  <acronym>PSYEDUC</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Charles Perrens, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Charles Perrens, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The involvement of family members is crucial and improves the prognosis of psychiatric&#xD;
      patients and reinforces therapeutic adherence and reduces the frequency of relapses. For&#xD;
      schizophrenia, the scientific literature clearly shows that it's in the interest of the&#xD;
      patient to offer to his family a psychoeducational program.&#xD;
&#xD;
      Therapeutic education programs are now part of the recommendations of good clinical practice&#xD;
      and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the&#xD;
      hospital and relating to patients, health and territories.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives We conducted a randomized study in two groups to evaluate the impact of a&#xD;
      psychoeducational program for caregivers.&#xD;
&#xD;
      Methods 60 patients with a DSM-V diagnosis of schizophrenia and their families' caregivers&#xD;
      are recruited. Families' caregivers are randomly assigned to receive either a 6 session&#xD;
      psychoeducation program, or no psychoeducation.&#xD;
&#xD;
      Baseline evaluations:&#xD;
&#xD;
      Patients: symptomatology (PANSS), medication adherence (MARS); Families' Caregivers: Quality&#xD;
      of Life (S-CGQoL), Burden (Zarit), knowledge of disease (KAST), therapeutic alliance (4PAS&#xD;
      caregivers), depression (CES-D), medication adherence (CRS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Actual">December 2020</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relapse</measure>
    <time_frame>baseline (pre-treatment) to six months post-baseline</time_frame>
    <description>Reduction in the rate of relapse (hospitalization) in patients whose family participated in the psychoeducation group compared to patients without psychoeducation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medication adherence (caregiver perception)</measure>
    <time_frame>baseline (pre-treatment) to six months post-baseline.</time_frame>
    <description>Change from baseline (pre-treatment) to 6 months post-baseline in caregiver-report of medication adherence using respectively the Compliance Rating Scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>baseline (pre-treatment) to six months post-baseline</time_frame>
    <description>Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of quality of life using the Schizophrenia Caregiver Quality of Life questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burden</measure>
    <time_frame>baseline (pre-treatment) to six months post-baseline</time_frame>
    <description>Change from baseline (pre-treatment) at 6 months post-baseline in family-report of burden using the Zarit Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Mental Disorder</condition>
  <condition>Educational Problems</condition>
  <condition>Family Relations</condition>
  <condition>Relapse</condition>
  <condition>Medication Adherence</condition>
  <condition>Psychiatric Disorder</condition>
  <condition>Psychiatric Hospitalization</condition>
  <arm_group>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 session of a psychoeducation program with the family. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <description>6 session psychoeducation program with the family caregiver of schizophrenics patients.</description>
    <arm_group_label>Psychoeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of schizophrenia, based on ICD-10 (F20 to F29)&#xD;
&#xD;
          -  Receive in-patient treatment at hospital (or medical center linked to Charles Perrens&#xD;
             Hospital)&#xD;
&#xD;
          -  Be the caregiver or parent of the patient&#xD;
&#xD;
          -  Patient informed of the diagnosis of his disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental retardation or other diagnoses that could affect the ability to answer&#xD;
             questionnaires, after the acute schizophrenia psychosis is controlled&#xD;
&#xD;
          -  Suicidal ideation&#xD;
&#xD;
          -  Non-comprehension of the French language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Charles PERRENS</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David MISDRAHI, M.D</last_name>
      <phone>003356563449</phone>
      <email>dmisdrahi@ch-perrens.fr</email>
    </contact>
    <contact_backup>
      <last_name>Arnaud TESSIER, M.Sc</last_name>
      <phone>003356563449</phone>
      <email>atessier@ch-perrens.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Misdrahi D, Petit M, Blanc O, Bayle F, Llorca PM. The influence of therapeutic alliance and insight on medication adherence in schizophrenia. Nord J Psychiatry. 2012 Feb;66(1):49-54. doi: 10.3109/08039488.2011.598556. Epub 2011 Aug 10.</citation>
    <PMID>21830849</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>psychoeducation program</keyword>
  <keyword>family caregiver</keyword>
  <keyword>relapse</keyword>
  <keyword>medication adherence</keyword>
  <keyword>burden</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03000985
org study id: PHRIP PSY EDUC 2013
nct id: NCT03000985
lead sponsor: 
has dmc: No
The involvement of family members is crucial and improves the prognosis of psychiatric
      patients and reinforces therapeutic adherence and reduces the frequency of relapses. For
      schizophrenia, the scientific literature clearly shows that it's in the interest of the
      patient to offer to his family a psychoeducational program.

      Therapeutic education programs are now part of the recommendations of good clinical practice
      and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the
      hospital and relating to patients, health and territories.
Objectives We conducted a randomized study in two groups to evaluate the impact of a
      psychoeducational program for caregivers.

      Methods 60 patients with a DSM-V diagnosis of schizophrenia and their families' caregivers
      are recruited. Families' caregivers are randomly assigned to receive either a 6 session
      psychoeducation program, or no psychoeducation.

      Baseline evaluations:

      Patients: symptomatology (PANSS), medication adherence (MARS); Families' Caregivers: Quality
      of Life (S-CGQoL), Burden (Zarit), knowledge of disease (KAST), therapeutic alliance (4PAS
      caregivers), depression (CES-D), medication adherence (CRS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Relapse
time frame: baseline (pre-treatment) to six months post-baseline
description: Reduction in the rate of relapse (hospitalization) in patients whose family participated in the psychoeducation group compared to patients without psychoeducation.
measure: Medication adherence (caregiver perception)
time frame: baseline (pre-treatment) to six months post-baseline.
description: Change from baseline (pre-treatment) to 6 months post-baseline in caregiver-report of medication adherence using respectively the Compliance Rating Scale.
measure: Quality of Life
time frame: baseline (pre-treatment) to six months post-baseline
description: Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of quality of life using the Schizophrenia Caregiver Quality of Life questionnaire.
measure: Burden
time frame: baseline (pre-treatment) to six months post-baseline
description: Change from baseline (pre-treatment) at 6 months post-baseline in family-report of burden using the Zarit Questionnaire.
arm group label: Psychoeducation
arm group type: Experimental
description: 6 session of a psychoeducation program with the family. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
arm group label: Control
arm group type: No Intervention
description: Treatment as usual
intervention type: Behavioral
intervention name: Psychoeducation
description: 6 session psychoeducation program with the family caregiver of schizophrenics patients.
arm group label: Psychoeducation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
citation: Misdrahi D, Petit M, Blanc O, Bayle F, Llorca PM. The influence of therapeutic alliance and insight on medication adherence in schizophrenia. Nord J Psychiatry. 2012 Feb;66(1):49-54. doi: 10.3109/08039488.2011.598556. Epub 2011 Aug 10.
PMID: 21830849
responsible party type: Sponsor
mesh term: Recurrence
mesh term: Schizophrenia
mesh term: Mental Disorders
mesh term: Problem Behavior