<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/NCT01731977</url>
  </required_header>
  <id_info>
    <org_study_id>NCU-708</org_study_id>
    <secondary_id>No. 29</secondary_id>
    <nct_id>NCT01731977</nct_id>
  </id_info>
  <brief_title>Strengths-Based Family Psychoeducation for Youth Psychosis</brief_title>
  <official_title>Effectiveness of the Strengths-Based Family Psychoeducation for Youth Psychosis: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nagoya City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aichi Health Promotion Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nagoya City University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The onset of Psychosis forces family members to bear a heavy burden of care. The mental&#xD;
      well-being of the family is so complicated that it is important to relieve their&#xD;
      psychological stresses. Although family psychoeducation has been established as an&#xD;
      evidence-based practice especially for schizophrenia, few studies have primarily intended to&#xD;
      reduce the distress of the family due to the burden of care. MacFarlane's multifamily&#xD;
      psychoeducation is one of the representative models of a group setting, which is based on the&#xD;
      behavioral therapeutic approach. In such psychological interventions, it has been emphasized&#xD;
      to focus on the strengths that a person originally has for coping with difficulties. The&#xD;
      intervention of mainly drawing the strengths from the family might empower them and lighten&#xD;
      their psychological burden.&#xD;
&#xD;
      The first 2-5 years from the onset of psychosis is regarded as the critical period to improve&#xD;
      the prognosis, so the intervention including more recent-onset psychotic patients might be of&#xD;
      use. With regard to a setting of the psychoeducational intervention, a homogeneous group one&#xD;
      can make the program better fitted for their problems. The present study aims to examine if&#xD;
      the strength-based family psychoeducaiton for youth psychosis in a group setting in addition&#xD;
      to the treatment as usual would be more effective for alleviating the psychological&#xD;
      distresses of the family than the treatment as usual alone. Moreover, its impact on the&#xD;
      family of recent-onset psychosis is explored as the subgroup.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psychosis, principally involving schizophrenia, is a severe mental illness that commonly&#xD;
      develops at a young age and often has a chronic course. The onset of Psychosis forces family&#xD;
      members to bear a heavy burden of care. It has been documented over and over again that the&#xD;
      mental well-being of the family is complicated. More than a dozen per cent of the family have&#xD;
      the morbidity corresponding to be depressive and anxiety disorders. It is important to&#xD;
      relieve their psychological stresses.&#xD;
&#xD;
      The concept of the burden of care is so broad and complex that its simple definition is a&#xD;
      challenging issue. It is usually defined as objective impacts on the household and subjective&#xD;
      consequences, which contain physical, economic, emotional and psychological components. The&#xD;
      psychological component involves the stigma against psychiatric disorders. The studies of&#xD;
      intervention to the family having a psychotic member have been mostly conducted for the&#xD;
      primary interest of reducing the rate of relapse and rehospitalization of the psychotic.&#xD;
      Their rationale of the intervention is based on the roles of the family that develop the&#xD;
      illness and cause a relapse (e.g., etiological relationship or expressed emotion). Although&#xD;
      family psychoeducation has been established as an evidence-based practice especially for&#xD;
      schizophrenic patients, few studies have primarily intended to reduce the burden of their&#xD;
      family.&#xD;
&#xD;
      Among various types of family psychoeducation, the group setting is considered as a better&#xD;
      method in terms of the creation of social support networks, limited medical resources and&#xD;
      cost-effectiveness. MacFarlane's multifamily psychoeducation is one of the representative&#xD;
      models of a group setting, which is composed of joining sessions, an educational workshop and&#xD;
      structured problem-solving group sessions. MacFarlane's model is based on the behavioral&#xD;
      therapeutic approach that mainly aims at stopping a vicious cycle. The cycle of schizophrenia&#xD;
      is peculiarly caused by expressed emotion, which is negative one expressed by the family that&#xD;
      lead to a high relapse rate (e.g., hostility or criticism).&#xD;
&#xD;
      In such psychological interventions, it has been emphasized to focus not only on the vicious&#xD;
      cycle but also on strengths. The strengths are defined as the power that a person has&#xD;
      originally for coping with difficulties. The intervention of mainly drawing out the strengths&#xD;
      of the family might empower them to face difficulties voluntarily and lighten their&#xD;
      psychological burden. However, to date, the effectiveness of family psychoeducation based on&#xD;
      the strengths approach has not been confirmed.&#xD;
&#xD;
      The onset of psychosis is generally at a young age. The first 2-5 years from the onset of&#xD;
      psychosis is regarded as the critical period to improve the prognosis, so the intervention&#xD;
      including more recent-onset psychotic patients might be of use. Additionally, the family of a&#xD;
      young patient has been reported to have strong concerns about returning to school, going to&#xD;
      work and getting married. With regard to a setting of the psychoeducational intervention, a&#xD;
      homogeneous group one can make the program better fitted for their problems and heighten&#xD;
      group cohesiveness.&#xD;
&#xD;
      The present study aims to examine if the strength-based family psychoeducaiton for youth&#xD;
      psychosis in a group setting in addition to the treatment as usual would be more effective&#xD;
      for alleviating the psychological distresses of the family than the treatment as usual alone.&#xD;
      Moreover, its impact on the family of recent-onset psychosis is explored as the subgroup.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the total score of trait anxiety of the Japanese version of the STAI at 14 weeks</measure>
    <time_frame>Baseline, 10 weeks, 14 weeks</time_frame>
    <description>The STAI is a self-report questionnaire to measure the intensity of anxiety. It consists of two categories that are state and trait anxiety. Trait anxiety measures relatively stable responses to anxiety-provoking experiences.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the proportion of the Japanese version of the K6 whose total score is less than nine at 14 weeks.</measure>
    <time_frame>Baseline, 10 weeks, 14 weeks</time_frame>
    <description>The K6 is a self-report questionnaire to measure mental well-being. The range of the score is 0 to 24 and a higher score indicates having poor mental health. The cutoff point is nine. Nine and more scores suggest that 50 percent of the subjects might be depressive or anxiety disorder.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in the total score of the Japanese vesion of the Link's stigma scale</measure>
    <time_frame>Baseline, 10 weeks, 14 weeks</time_frame>
    <description>The Link's stigma scale is a self-report questionnaire to measure the intensity of stigma attached to mental disorders. This scale is intended for general citizens, patients and their family.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in the total score of state anxiety of the Japanese version of the STAI</measure>
    <time_frame>Baseline, 10 weeks, 14 weeks</time_frame>
    <description>State Anxiety measures temporary situational responses to anxiety-provoking experiences.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in the total score of the short version of the Japanese version of the Zarit Burden Interview (J-ZBI-8).</measure>
    <time_frame>Baseline, 10 weeks, 14 weeks</time_frame>
    <description>The J-ZBI-8 is a self-report questionnaire to measure the intensity of family care burden. The 8-items short version was developed from the Zarit Burden Interview that contains twenty-two items.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in the total score of the Japanese version of the family Attitude Scale (FAS).</measure>
    <time_frame>Baseline, 10 weeks, 14 weeks</time_frame>
    <description>The FAS is a self-report questionnaire to measure the intensity of expressed emotion (EE). Hostility, high criticism and low warmth on the Camberwell Family Interview that is the gold standard to masure EE are associated with a higher scores of the FAS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in the total score of the Japanese version of the K6</measure>
    <time_frame>Baseline, 10 weeks, 14 weeks</time_frame>
    <description>The K6 is a self-report questionnaire to measure mental well-being. The range of the score is 0 to 24 and a higher score indicates having poor mental health.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in the score of the Japanese version of the Global Assessment of Functioning (GAF)</measure>
    <time_frame>Baseline, 10 weeks, 14 weeks</time_frame>
    <description>The GAF is an analogous scale that evaluates the current objective symptomatic and functional conditions of patients. The range of the score is 0 to 100 and a higher score indicates having better conditions.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Psychological Stresses</condition>
  <arm_group>
    <arm_group_label>Strengths-based family psychoeducation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family psychoeducation in addition to treatment as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list</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>Strengths-based family psychoeducation</intervention_name>
    <description>Family psychoeducation in a group setting is performed every two weeks for eight weeks.</description>
    <arm_group_label>Strengths-based family psychoeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient&#xD;
&#xD;
               1. whose age is between 15 and 39 years old&#xD;
&#xD;
               2. who currently takes outpatient treatment&#xD;
&#xD;
               3. who fulfills the diagnostic criteria of the DSM-IV-TR for schizophrenia, brief&#xD;
                  psychotic disorder, schizophreniform disorder, schizoaffective disorder or&#xD;
                  delusional disorder&#xD;
&#xD;
               4. who is a native speaker of Japanese&#xD;
&#xD;
          -  The family&#xD;
&#xD;
               1. whose age is between 20 and 74 years old&#xD;
&#xD;
               2. who is classified as one of the four relationships with the patient; parent,&#xD;
                  spouse, sibling and someone who has been living together more than 3 months&#xD;
&#xD;
               3. who is a native speaker of Japanese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient&#xD;
&#xD;
               1. who fulfills the diagnostic criteria of the DSM-IV-TR for mood disorders with&#xD;
                  psychotic features, substance-induced psychotic disorder or psychotic disorder&#xD;
                  due to the general medical condition&#xD;
&#xD;
               2. who has been diagnosed with mental retardation or cluster B personality disorders&#xD;
                  by the doctor in charge&#xD;
&#xD;
          -  The family&#xD;
&#xD;
               1. who has a communication problem for any reason (e.g. psychotic disorders,&#xD;
                  dementia or cluster B personality disorders)&#xD;
&#xD;
               2. who is judged not suitable for participating in this study for any reason by the&#xD;
                  doctor in charge of the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nao Shiraishi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kusunokikai Kusunoki Mental Hospital</name>
      <address>
        <city>Nagoya City</city>
        <state>Aichi Prefecture</state>
        <zip>462-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiseikai Yagoto Hospital</name>
      <address>
        <city>Nagoya City</city>
        <state>Aichi Prefecture</state>
        <zip>468-0073</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyouseikai Minamichita Hospital</name>
      <address>
        <city>Nagoya City</city>
        <state>Aichi Prefecture</state>
        <zip>470-3411</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kenseikai Toyota-nishi Hospital</name>
      <address>
        <city>Toyota City</city>
        <state>Aichi Prefecture</state>
        <zip>470-0344</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>January 2, 2016</last_update_submitted>
  <last_update_submitted_qc>January 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nagoya City University</investigator_affiliation>
    <investigator_full_name>Nao Shiraishi</investigator_full_name>
    <investigator_title>Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences</investigator_title>
  </responsible_party>
  <keyword>Psychotherapy, Psychotic disorders, Caregiver</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</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/NCT01731977
org study id: NCU-708
secondary id: No. 29
nct id: NCT01731977
lead sponsor: 
collaborator: 
has dmc: No
The onset of Psychosis forces family members to bear a heavy burden of care. The mental
      well-being of the family is so complicated that it is important to relieve their
      psychological stresses. Although family psychoeducation has been established as an
      evidence-based practice especially for schizophrenia, few studies have primarily intended to
      reduce the distress of the family due to the burden of care. MacFarlane's multifamily
      psychoeducation is one of the representative models of a group setting, which is based on the
      behavioral therapeutic approach. In such psychological interventions, it has been emphasized
      to focus on the strengths that a person originally has for coping with difficulties. The
      intervention of mainly drawing the strengths from the family might empower them and lighten
      their psychological burden.

      The first 2-5 years from the onset of psychosis is regarded as the critical period to improve
      the prognosis, so the intervention including more recent-onset psychotic patients might be of
      use. With regard to a setting of the psychoeducational intervention, a homogeneous group one
      can make the program better fitted for their problems. The present study aims to examine if
      the strength-based family psychoeducaiton for youth psychosis in a group setting in addition
      to the treatment as usual would be more effective for alleviating the psychological
      distresses of the family than the treatment as usual alone. Moreover, its impact on the
      family of recent-onset psychosis is explored as the subgroup.
Psychosis, principally involving schizophrenia, is a severe mental illness that commonly
      develops at a young age and often has a chronic course. The onset of Psychosis forces family
      members to bear a heavy burden of care. It has been documented over and over again that the
      mental well-being of the family is complicated. More than a dozen per cent of the family have
      the morbidity corresponding to be depressive and anxiety disorders. It is important to
      relieve their psychological stresses.

      The concept of the burden of care is so broad and complex that its simple definition is a
      challenging issue. It is usually defined as objective impacts on the household and subjective
      consequences, which contain physical, economic, emotional and psychological components. The
      psychological component involves the stigma against psychiatric disorders. The studies of
      intervention to the family having a psychotic member have been mostly conducted for the
      primary interest of reducing the rate of relapse and rehospitalization of the psychotic.
      Their rationale of the intervention is based on the roles of the family that develop the
      illness and cause a relapse (e.g., etiological relationship or expressed emotion). Although
      family psychoeducation has been established as an evidence-based practice especially for
      schizophrenic patients, few studies have primarily intended to reduce the burden of their
      family.

      Among various types of family psychoeducation, the group setting is considered as a better
      method in terms of the creation of social support networks, limited medical resources and
      cost-effectiveness. MacFarlane's multifamily psychoeducation is one of the representative
      models of a group setting, which is composed of joining sessions, an educational workshop and
      structured problem-solving group sessions. MacFarlane's model is based on the behavioral
      therapeutic approach that mainly aims at stopping a vicious cycle. The cycle of schizophrenia
      is peculiarly caused by expressed emotion, which is negative one expressed by the family that
      lead to a high relapse rate (e.g., hostility or criticism).

      In such psychological interventions, it has been emphasized to focus not only on the vicious
      cycle but also on strengths. The strengths are defined as the power that a person has
      originally for coping with difficulties. The intervention of mainly drawing out the strengths
      of the family might empower them to face difficulties voluntarily and lighten their
      psychological burden. However, to date, the effectiveness of family psychoeducation based on
      the strengths approach has not been confirmed.

      The onset of psychosis is generally at a young age. The first 2-5 years from the onset of
      psychosis is regarded as the critical period to improve the prognosis, so the intervention
      including more recent-onset psychotic patients might be of use. Additionally, the family of a
      young patient has been reported to have strong concerns about returning to school, going to
      work and getting married. With regard to a setting of the psychoeducational intervention, a
      homogeneous group one can make the program better fitted for their problems and heighten
      group cohesiveness.

      The present study aims to examine if the strength-based family psychoeducaiton for youth
      psychosis in a group setting in addition to the treatment as usual would be more effective
      for alleviating the psychological distresses of the family than the treatment as usual alone.
      Moreover, its impact on the family of recent-onset psychosis is explored as the subgroup.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline in the total score of trait anxiety of the Japanese version of the STAI at 14 weeks
time frame: Baseline, 10 weeks, 14 weeks
description: The STAI is a self-report questionnaire to measure the intensity of anxiety. It consists of two categories that are state and trait anxiety. Trait anxiety measures relatively stable responses to anxiety-provoking experiences.
measure: Change from baseline in the proportion of the Japanese version of the K6 whose total score is less than nine at 14 weeks.
time frame: Baseline, 10 weeks, 14 weeks
description: The K6 is a self-report questionnaire to measure mental well-being. The range of the score is 0 to 24 and a higher score indicates having poor mental health. The cutoff point is nine. Nine and more scores suggest that 50 percent of the subjects might be depressive or anxiety disorder.
measure: Change from baseline in the total score of the Japanese vesion of the Link's stigma scale
time frame: Baseline, 10 weeks, 14 weeks
description: The Link's stigma scale is a self-report questionnaire to measure the intensity of stigma attached to mental disorders. This scale is intended for general citizens, patients and their family.
measure: Change from baseline in the total score of state anxiety of the Japanese version of the STAI
time frame: Baseline, 10 weeks, 14 weeks
description: State Anxiety measures temporary situational responses to anxiety-provoking experiences.
measure: Change from baseline in the total score of the short version of the Japanese version of the Zarit Burden Interview (J-ZBI-8).
time frame: Baseline, 10 weeks, 14 weeks
description: The J-ZBI-8 is a self-report questionnaire to measure the intensity of family care burden. The 8-items short version was developed from the Zarit Burden Interview that contains twenty-two items.
measure: Change from baseline in the total score of the Japanese version of the family Attitude Scale (FAS).
time frame: Baseline, 10 weeks, 14 weeks
description: The FAS is a self-report questionnaire to measure the intensity of expressed emotion (EE). Hostility, high criticism and low warmth on the Camberwell Family Interview that is the gold standard to masure EE are associated with a higher scores of the FAS.
measure: Change from baseline in the total score of the Japanese version of the K6
time frame: Baseline, 10 weeks, 14 weeks
description: The K6 is a self-report questionnaire to measure mental well-being. The range of the score is 0 to 24 and a higher score indicates having poor mental health.
measure: Change from baseline in the score of the Japanese version of the Global Assessment of Functioning (GAF)
time frame: Baseline, 10 weeks, 14 weeks
description: The GAF is an analogous scale that evaluates the current objective symptomatic and functional conditions of patients. The range of the score is 0 to 100 and a higher score indicates having better conditions.
arm group label: Strengths-based family psychoeducation
arm group type: Experimental
description: Family psychoeducation in addition to treatment as usual
arm group label: Waiting list
arm group type: No Intervention
description: Treatment as usual
intervention type: Behavioral
intervention name: Strengths-based family psychoeducation
description: Family psychoeducation in a group setting is performed every two weeks for eight weeks.
arm group label: Strengths-based family psychoeducation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 74 Years
healthy volunteers: No
last name: Nao Shiraishi, MD
role: Principal Investigator
affiliation: Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Nagoya City University
investigator full name: Nao Shiraishi
investigator title: Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
mesh term: Stress, Psychological