<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/NCT01734291</url>
  </required_header>
  <id_info>
    <org_study_id>NCUPsychiatricNursing001</org_study_id>
    <secondary_id>ID24593499</secondary_id>
    <nct_id>NCT01734291</nct_id>
  </id_info>
  <brief_title>Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression</brief_title>
  <official_title>Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nagoya City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nagoya City University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the effectiveness of brief multifamily&#xD;
      psychoeducation to relieve the psychological distress of families of patients with chronic&#xD;
      major depression and to improve their family functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Major depressive disorder (MDD) is a long-lasting illness with significant effects on the&#xD;
      patient's family, social life, and work life. Treatment failure results in a low recovery&#xD;
      rate and frequent relapses.&#xD;
&#xD;
      Relatives of patients with MDD are fraught with heavy psychosocial burden and show increased&#xD;
      rates of depression and anxiety. Among relatives of patients with MDD, the patient's behavior&#xD;
      and mood disturbance and relative's emotional distress were associated with the relatives'&#xD;
      burden.&#xD;
&#xD;
      Family psychoeducation is recognized as part of the optimal treatment for patients with&#xD;
      psychotic disorder. This intervention has been shown to reduce the rates of relapse and&#xD;
      hospitalization among individuals with psychotic disorders and is recognized as an&#xD;
      evidenced-based treatment for psychotic disorder. Several randomized controlled trials have&#xD;
      found that family psychoeducation is effective in enhancing the course of bipolar disorder.&#xD;
      However, there are few studies on psychoeducation of families of patients with MDD.&#xD;
&#xD;
      The purpose of this study is to examine the effectiveness of brief multifamily&#xD;
      psychoeducation to relieve the psychological distress of families of patients with chronic&#xD;
      major depression and to improve their family functioning, in a randomized controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">October 9, 2016</completion_date>
  <primary_completion_date type="Actual">June 20, 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of total score of K6 of family members</measure>
    <time_frame>The base line, 8, 16 and 32</time_frame>
    <description>The K6 questionnaire is a six-item self-report questionnaire that was developed to screen for DSM-IV depressive and anxiety disorder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of total score of Family Attitude Scale(FAS) of family members</measure>
    <time_frame>The base line, 8, 16 and 32</time_frame>
    <description>The Family Attitude Scale(FAS) is a 30-item self report inventory and measures families' Expressed Emotion(EE).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Family psychoeducation plus TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family psychoeducational therapy in addition to treatment as usual for the patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual(TAU)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treatment as usual administered by physician and counseling administered by nurse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family psychoeducation</intervention_name>
    <description>Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians</description>
    <arm_group_label>Family psychoeducation plus TAU</arm_group_label>
    <arm_group_label>Treatment as usual(TAU)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meets the criteria for Major Depressive Disorder (MDD) according to DSM-IV.&#xD;
&#xD;
          2. Receives antidepressant therapy.&#xD;
&#xD;
          3. The patient had the first episode of MDD more than one year ago.&#xD;
&#xD;
          4. Currently fulfills the diagnostic threshold for major depressive episode or partial&#xD;
             remission.&#xD;
&#xD;
          5. The patient and their family member(s) are aged between 18 and 85 years.&#xD;
&#xD;
          6. The patient has lived with his/her family at the time of participating in this study&#xD;
             and is expected to live with his/her family during the investigation period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who undergo electroconvulsive therapy (ECT) during the investigation period.&#xD;
&#xD;
          2. Patients who are at serious suicidal risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fujika Katsuki, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nagoya City University, School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fujika Katsuki</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>467-8601</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <reference>
    <citation>Katsuki F, Takeuchi H, Watanabe N, Shiraishi N, Maeda T, Kubota Y, Suzuki M, Yamada A, Akechi T. Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial. Trials. 2014 Aug 12;15:320. doi: 10.1186/1745-6215-15-320.</citation>
    <PMID>25118129</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>April 3, 2017</last_update_submitted>
  <last_update_submitted_qc>April 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nagoya City University</investigator_affiliation>
    <investigator_full_name>Fujika Katsuki</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Family psychoeducation</keyword>
  <keyword>Major depressive disorder</keyword>
  <keyword>Family burden</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>
    <mesh_term>Depressive Disorder, Major</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/NCT01734291
org study id: NCUPsychiatricNursing001
secondary id: ID24593499
nct id: NCT01734291
lead sponsor: 
has dmc: No
The purpose of this study is to examine the effectiveness of brief multifamily
      psychoeducation to relieve the psychological distress of families of patients with chronic
      major depression and to improve their family functioning.
Major depressive disorder (MDD) is a long-lasting illness with significant effects on the
      patient's family, social life, and work life. Treatment failure results in a low recovery
      rate and frequent relapses.

      Relatives of patients with MDD are fraught with heavy psychosocial burden and show increased
      rates of depression and anxiety. Among relatives of patients with MDD, the patient's behavior
      and mood disturbance and relative's emotional distress were associated with the relatives'
      burden.

      Family psychoeducation is recognized as part of the optimal treatment for patients with
      psychotic disorder. This intervention has been shown to reduce the rates of relapse and
      hospitalization among individuals with psychotic disorders and is recognized as an
      evidenced-based treatment for psychotic disorder. Several randomized controlled trials have
      found that family psychoeducation is effective in enhancing the course of bipolar disorder.
      However, there are few studies on psychoeducation of families of patients with MDD.

      The purpose of this study is to examine the effectiveness of brief multifamily
      psychoeducation to relieve the psychological distress of families of patients with chronic
      major depression and to improve their family functioning, in a randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change of total score of K6 of family members
time frame: The base line, 8, 16 and 32
description: The K6 questionnaire is a six-item self-report questionnaire that was developed to screen for DSM-IV depressive and anxiety disorder.
measure: The change of total score of Family Attitude Scale(FAS) of family members
time frame: The base line, 8, 16 and 32
description: The Family Attitude Scale(FAS) is a 30-item self report inventory and measures families' Expressed Emotion(EE).
arm group label: Family psychoeducation plus TAU
arm group type: Active Comparator
description: Family psychoeducational therapy in addition to treatment as usual for the patients.
arm group label: Treatment as usual(TAU)
arm group type: Placebo Comparator
description: Treatment as usual administered by physician and counseling administered by nurse.
intervention type: Behavioral
intervention name: Family psychoeducation
description: Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians
arm group label: Family psychoeducation plus TAU
arm group label: Treatment as usual(TAU)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Fujika Katsuki, Dr
role: Principal Investigator
affiliation: Nagoya City University, School of Nursing
facility: 
country: Japan
citation: Katsuki F, Takeuchi H, Watanabe N, Shiraishi N, Maeda T, Kubota Y, Suzuki M, Yamada A, Akechi T. Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial. Trials. 2014 Aug 12;15:320. doi: 10.1186/1745-6215-15-320.
PMID: 25118129
responsible party type: Principal Investigator
investigator affiliation: Nagoya City University
investigator full name: Fujika Katsuki
investigator title: Associate Professor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major