<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/NCT02202694</url>
  </required_header>
  <id_info>
    <org_study_id>CBT-PSY-01</org_study_id>
    <nct_id>NCT02202694</nct_id>
  </id_info>
  <brief_title>Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan</brief_title>
  <official_title>Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim:&#xD;
&#xD;
      To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in&#xD;
      Pakistan.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Randomized Control Trial&#xD;
&#xD;
      Setting:&#xD;
&#xD;
      Psychiatry Departments of General Hospitals in Karachi.&#xD;
&#xD;
      Participants:&#xD;
&#xD;
      A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a&#xD;
      psychological intervention or treatment as usual arm.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Culturally Adapted Cognitive Behavioral Therapy (CBT)&#xD;
&#xD;
      Outcome measure:&#xD;
&#xD;
      Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to test the feasibility of culturally adaptive CBT for Psychosis&#xD;
      in Pakistan&#xD;
&#xD;
      Primary :&#xD;
&#xD;
      -To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in&#xD;
      Pakistan.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        -  To assess fidelity of culturally-adapted CBT for psychosis.&#xD;
&#xD;
        -  To further modify CaCBTp in accordance with findings of feasibility study&#xD;
&#xD;
      The Participants will be recruited from psychiatric department of different hospitals.They&#xD;
      will be randomly divided into two groups; intervention group and treatment-as-usual group. A&#xD;
      total of thirtysix participants will be recruited in the feasibility study and divided&#xD;
      equally into two arms. This will ensure that, even after loss to follow-up, the investigators&#xD;
      will have at 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 CaCBTp will be delivered by trained research clinician&#xD;
      for a period of three months. Participants in the treatment as usual (TAU) group will be&#xD;
      given details of intervention at the end of the study and interested Participants will be&#xD;
      offered CaCBTp.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Positive and Negative syndrome scale (PANSS)</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychotic Symptom Rating Scales (PSYRATS)</measure>
    <time_frame>Baseline ,3 months &amp; 6 months</time_frame>
    <description>The PSYRATS consists of 17 items that focus on auditory hallucinations and delusions experienced over the past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insight rating scale</measure>
    <time_frame>Baseline ,3 months &amp; 6 months</time_frame>
    <description>Assesses Improvement in insight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calgary Depression Scale for Schizophrenia</measure>
    <time_frame>Baseline ,3 months &amp; 6 months</time_frame>
    <description>This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Explanatory Model Interview</measure>
    <time_frame>Baseline ,3 months &amp; 6 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>Psychosis</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Culturally Adapted Cognitive Behavior Therapy</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>Culturally Adapted Cognitive behavior therapy</intervention_name>
    <description>This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Psychosocial intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Psychosis established by clinician using ICD10 criteria.&#xD;
&#xD;
          2. Individuals aged between 18-65.&#xD;
&#xD;
          3. Should not have learning disability.&#xD;
&#xD;
          4. Resident of Karachi.&#xD;
&#xD;
          5. Participant is able to give informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe illness which may affect capacity or markedly affect their ability to&#xD;
             participate in interview, e.g. very thought disordered or distressed by symptoms.&#xD;
&#xD;
          2. Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence&#xD;
             according to ICD10 RDC).&#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 Kazmi</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>
  <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>July 2014</verification_date>
  <study_first_submitted>April 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CBT, Psychosis, cultural adaptation, Pakistan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</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/NCT02202694
org study id: CBT-PSY-01
nct id: NCT02202694
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Aim:

      To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in
      Pakistan.

      Design:

      Randomized Control Trial

      Setting:

      Psychiatry Departments of General Hospitals in Karachi.

      Participants:

      A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a
      psychological intervention or treatment as usual arm.

      Intervention:

      Culturally Adapted Cognitive Behavioral Therapy (CBT)

      Outcome measure:

      Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)
The purpose of the study is to test the feasibility of culturally adaptive CBT for Psychosis
      in Pakistan

      Primary :

      -To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in
      Pakistan.

      Secondary:

        -  To assess fidelity of culturally-adapted CBT for psychosis.

        -  To further modify CaCBTp in accordance with findings of feasibility study

      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 thirtysix participants will be recruited in the feasibility study and divided
      equally into two arms. This will ensure that, even after loss to follow-up, the investigators
      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 CaCBTp will be delivered by trained research clinician
      for a period of three months. Participants in the treatment as usual (TAU) group will be
      given details of intervention at the end of the study and interested Participants will be
      offered CaCBTp.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Positive and Negative syndrome scale (PANSS)
time frame: up to 6 months
description: The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
measure: Psychotic Symptom Rating Scales (PSYRATS)
time frame: Baseline ,3 months & 6 months
description: The PSYRATS consists of 17 items that focus on auditory hallucinations and delusions experienced over the past week.
measure: Insight rating scale
time frame: Baseline ,3 months & 6 months
description: Assesses Improvement in insight
measure: Calgary Depression Scale for Schizophrenia
time frame: Baseline ,3 months & 6 months
description: This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia.
measure: Short Explanatory Model Interview
time frame: Baseline ,3 months & 6 months
description: used to elicit beliefs of mental illness
arm group label: Intervention
arm group type: Experimental
description: Culturally Adapted Cognitive Behavior Therapy
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: Culturally Adapted Cognitive behavior therapy
description: This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
arm group label: Intervention
other name: Psychosocial 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 Kazmi
role: Principal Investigator
affiliation: Pakistan Institute of Living and Learning
last name: Munir Hamirani, FCPS
role: Principal Investigator
affiliation: Abbasi Shaheed Hospital
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Psychotic Disorders
mesh term: Mental Disorders