<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/NCT02210390</url>
  </required_header>
  <id_info>
    <org_study_id>PSY-BPD-03</org_study_id>
    <nct_id>NCT02210390</nct_id>
  </id_info>
  <brief_title>Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan</brief_title>
  <official_title>Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pakistan Institute of Living and Learning</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dow University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abbasi Shaheed Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pakistan Institute of Living and Learning</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim:&#xD;
&#xD;
      To assess the Feasibility RCT of the efficacy of a culturally adapted psychological&#xD;
      intervention for Bipolar disorder in Pakistan&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Randomized Control Trial&#xD;
&#xD;
      Setting:&#xD;
&#xD;
      Psychiatric Departments of different Hospitals in Karachi.&#xD;
&#xD;
      Participants:&#xD;
&#xD;
      A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and&#xD;
      treatment as usual arm.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Culturally Adapted psychological intervention for bipolar disorder&#xD;
&#xD;
      Outcome measure:&#xD;
&#xD;
        -  Acceptance of intervention in terms of attending session and dropouts&#xD;
&#xD;
        -  Knowledge and attitudes towards bipolar disorder&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted&#xD;
      psychological intervention for Bipolar disorder in Pakistan&#xD;
&#xD;
      Primary Objectives :&#xD;
&#xD;
        1. To determine effectiveness of educational intervention in terms of patient Satisfaction&#xD;
           with overall care, knowledge and attitudes to bipolar disorder and medication adherence.&#xD;
&#xD;
        2. To assess feasibility in terms of&#xD;
&#xD;
             -  Recruitment&#xD;
&#xD;
             -  Using instruments that will be used to assess recurrence rate in the main study&#xD;
                (BDI, YMRS and obtaining prospective hospitalisation and medication data)&#xD;
&#xD;
             -  acceptability of a culturally adapted bipolar group education package&#xD;
&#xD;
        3. To allow 'fine tuning' of culturally adapted bipolar group education package (this will&#xD;
           partly be achieved by using the SEMI at study entry)&#xD;
&#xD;
      The Participants will be recruited from psychiatric department of different hospitals.&#xD;
&#xD;
      They will be randomly divided into two groups; intervention group and treatment-as-usual&#xD;
      group. A total of thirty six participants will be recruited in the pilot study and divided&#xD;
      equally into two arms. This will ensure that, even after loss to follow-up, we will have at&#xD;
      least 12 subjects per group for analysis (FDA guidance&#xD;
      http://www.fda.gov/cder/guidance/5356fnl.pdf) .Randomization will be carried out by the on&#xD;
      offsite statistician. This will provide a reliable geographically remote service. For&#xD;
      intervention group twelve sessions of psychoeducation will be provided by trained research&#xD;
      clinician during the period of three months. Patients in the treatment as usual (TAU) group&#xD;
      will be given details of intervention at the end of the study and interested patients will be&#xD;
      offered psychoeducation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Young Mania Rating Scale(YMRS)</measure>
    <time_frame>three months</time_frame>
    <description>The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge and attitudes</measure>
    <time_frame>three months</time_frame>
    <description>Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck's Depression Inventory Scale (BDI)</measure>
    <time_frame>three months</time_frame>
    <description>The BDI is a measure of depression severity and has been used in several previous studies in Pakistan and is validated for use in Urdu.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>three months</time_frame>
    <description>Self-reported Measure of Medication adherence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>three months</time_frame>
    <description>Patient satisfaction with overall care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Explanatory Model Interview</measure>
    <time_frame>three months</time_frame>
    <description>used to elicit beliefs of mental illness</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psycho-education Sessions will be offered weekly basis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who will be randomized to the &quot;treatment as usual&quot; arm will receive routine care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psycho education</intervention_name>
    <description>Psycho-education Sessions will be offered weekly basis</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of DSM IV Bipolar disorder&#xD;
&#xD;
          -  Currently stable (YMRS &lt;8, BDI&lt;12)&#xD;
&#xD;
          -  Age 18 to 65 years.&#xD;
&#xD;
          -  Participants engaged with the mental health services since last 6 months.&#xD;
&#xD;
          -  Able to give written informed consent.&#xD;
&#xD;
          -  Resident of trial catchments area&#xD;
&#xD;
          -  Ability to speak Urdu /Punjabi&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substance or alcohol dependent (i.e., those who fulfill the criteria for dependence&#xD;
             according to DSM IV criteria)&#xD;
&#xD;
          -  Inability to engage fully in the psychotherapy (due to cognitive impairment)&#xD;
&#xD;
          -  Actively suicidal&#xD;
&#xD;
          -  Any major psychiatric illness other than bipolar disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nusrat Husain, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pakistan Institute of Learning and Living, University of Manchester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Imran Chaudhry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Farooq Naeem, MRCPsych</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pakistan Institute of Learning and Living, University of Southampton</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raza Ur Rehman, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dow University of Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ajmal kazm</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pakistan Institute of Living and Learning</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Munir Hamirani, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abbasi Shaheed Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muhammad I Husain, MRCPsych</last_name>
    <role>Principal Investigator</role>
    <affiliation>Camden and Islington NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dow University of Health Sciences</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psycho-education, Bipolar , cultural adaptation, Pakistan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</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/NCT02210390
org study id: PSY-BPD-03
nct id: NCT02210390
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Aim:

      To assess the Feasibility RCT of the efficacy of a culturally adapted psychological
      intervention for Bipolar disorder in Pakistan

      Design:

      Randomized Control Trial

      Setting:

      Psychiatric Departments of different Hospitals in Karachi.

      Participants:

      A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and
      treatment as usual arm.

      Intervention:

      Culturally Adapted psychological intervention for bipolar disorder

      Outcome measure:

        -  Acceptance of intervention in terms of attending session and dropouts

        -  Knowledge and attitudes towards bipolar disorder
The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted
      psychological intervention for Bipolar disorder in Pakistan

      Primary Objectives :

        1. To determine effectiveness of educational intervention in terms of patient Satisfaction
           with overall care, knowledge and attitudes to bipolar disorder and medication adherence.

        2. To assess feasibility in terms of

             -  Recruitment

             -  Using instruments that will be used to assess recurrence rate in the main study
                (BDI, YMRS and obtaining prospective hospitalisation and medication data)

             -  acceptability of a culturally adapted bipolar group education package

        3. To allow 'fine tuning' of culturally adapted bipolar group education package (this will
           partly be achieved by using the SEMI at study entry)

      The Participants will be recruited from psychiatric department of different hospitals.

      They will be randomly divided into two groups; intervention group and treatment-as-usual
      group. A total of thirty six participants will be recruited in the pilot study and divided
      equally into two arms. This will ensure that, even after loss to follow-up, we will have at
      least 12 subjects per group for analysis (FDA guidance
      http://www.fda.gov/cder/guidance/5356fnl.pdf) .Randomization will be carried out by the on
      offsite statistician. This will provide a reliable geographically remote service. For
      intervention group twelve sessions of psychoeducation will be provided by trained research
      clinician during the period of three months. Patients in the treatment as usual (TAU) group
      will be given details of intervention at the end of the study and interested patients will be
      offered psychoeducation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Young Mania Rating Scale(YMRS)
time frame: three months
description: The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms
measure: Knowledge and attitudes
time frame: three months
description: Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
measure: Beck's Depression Inventory Scale (BDI)
time frame: three months
description: The BDI is a measure of depression severity and has been used in several previous studies in Pakistan and is validated for use in Urdu.
measure: Medication adherence
time frame: three months
description: Self-reported Measure of Medication adherence
measure: Visual Analogue Scale
time frame: three months
description: Patient satisfaction with overall care
measure: Short Explanatory Model Interview
time frame: three months
description: used to elicit beliefs of mental illness
arm group label: Intervention
arm group type: Experimental
description: Psycho-education Sessions will be offered weekly basis
arm group label: Control
arm group type: No Intervention
description: Patients who will be randomized to the "treatment as usual" arm will receive routine care
intervention type: Behavioral
intervention name: Psycho education
description: Psycho-education Sessions will be offered weekly basis
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nusrat Husain, MD
role: Principal Investigator
affiliation: Pakistan Institute of Learning and Living, University of Manchester
last name: Imran Chaudhry, MD
role: Principal Investigator
affiliation: University of Manchester
last name: Farooq Naeem, MRCPsych
role: Principal Investigator
affiliation: Pakistan Institute of Learning and Living, University of Southampton
last name: Raza Ur Rehman, FCPS
role: Principal Investigator
affiliation: Dow University of Health Sciences
last name: Ajmal kazm
role: Principal Investigator
affiliation: Pakistan Institute of Living and Learning
last name: Munir Hamirani, FCPS
role: Principal Investigator
affiliation: Abbasi Shaheed Hospital
last name: Muhammad I Husain, MRCPsych
role: Principal Investigator
affiliation: Camden and Islington NHS Foundation Trust
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Bipolar Disorder