<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/NCT01725932</url>
  </required_header>
  <id_info>
    <org_study_id>PACT_SHCBTD_2012</org_study_id>
    <nct_id>NCT01725932</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression</brief_title>
  <acronym>CaCBT_SH</acronym>
  <official_title>A Multicentre Randomised Controlled Trial of Culturally Adapted CBT Based Self Help Manual for Depression in Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pakistan Association of Cognitive Therapists</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pakistan Association of Cognitive Therapists</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression&#xD;
      in West, only limited amount of research has been conducted to find assess its effectiveness&#xD;
      in low and middle income countries. We have developed culturally sensitive CBT during the&#xD;
      last few years in Pakistan. Pakistan has high rates of depression. And there is currently a&#xD;
      need to develop and test evidence based treatments which are culturally sensitive and cost&#xD;
      effective. IN this project we will be assessing the effectiveness of a culturally sensitive&#xD;
      CBT based self help intervention for depression in Pakistan against care as usual, using a&#xD;
      randomized controlled design.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Hospital Anxiety and depression Rating Scale- Depression subscale</measure>
    <time_frame>Participants will be assessed at baseline and then end of therapy at 12 weeks</time_frame>
    <description>Measurement of depression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale, Anxiety subscale</measure>
    <time_frame>Participants will be assessed at baseline and then end of therapy at 12 weeks</time_frame>
    <description>Measurement of anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bradford Somatic Inventory</measure>
    <time_frame>Participants will be assessed at baseline and then end of therapy at 12 weeks</time_frame>
    <description>Measurement of somatic symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief disability questionnaire</measure>
    <time_frame>Participants will be assessed at baseline and then end of therapy at 12 weeks</time_frame>
    <description>To measure disability associated with depression</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Culturally adapted CBT based Self Help</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Culturally sensitive cbt based self help intervention, which consists of 6 regular chapters and 2 additional chapters. The self help intervention involves family to improve compliance with the intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care As Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Culturally adapted CBT based Self Help</intervention_name>
    <description>Intervention was based on our initial work using mixed methods, using mixed methods,in Pakistan. It focused on psycho-education, symptoms management, changing negative thinking, behavioral activation, problem solving, improving relationships and communication skills. One person from the family was involved in all cases. The intervention consists of 7 chapters. Manual can be used by the patient's or carers with at least 5 years of education. A member of the research team called them once every week to remind them of the next chapter and also to discuss any issues o problems that emerged during the previous week. This manual can be downloaded from PACT website (http://www.pactorganization.com/)</description>
    <arm_group_label>Culturally adapted CBT based Self Help</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All those who fulfil the diagnosis of Depressive episode (F32) or Recurrent depressive&#xD;
             disorder (F33 except 33.4 ) using ICD10 RDC (International Classification of Diseases,&#xD;
             Research Diagnostic Criteria), scored 8 or more on HADS (Hospital Anxiety and&#xD;
             Depression Scale) Depression Sub-scale, are between the ages of 18-60 and either&#xD;
             patient or the carer has at least 5 years of education.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria include; excessive use of alcohol or drugs (using ICD 10 RDC&#xD;
             for alcohol or drug abuse or dependence) significant cognitive impairment (for example&#xD;
             learning disability or dementia) and active psychosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehwish Khalid, MSc</last_name>
    <role>Study Director</role>
    <affiliation>PACT</affiliation>
  </overall_official>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>June 16, 2013</last_update_submitted>
  <last_update_submitted_qc>June 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 18, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>culture, depression, cognitive therapy, behaviour therapy,</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>
  </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/NCT01725932
org study id: PACT_SHCBTD_2012
nct id: NCT01725932
lead sponsor: 
has dmc: Yes
While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression
      in West, only limited amount of research has been conducted to find assess its effectiveness
      in low and middle income countries. We have developed culturally sensitive CBT during the
      last few years in Pakistan. Pakistan has high rates of depression. And there is currently a
      need to develop and test evidence based treatments which are culturally sensitive and cost
      effective. IN this project we will be assessing the effectiveness of a culturally sensitive
      CBT based self help intervention for depression in Pakistan against care as usual, using a
      randomized controlled design.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Hospital Anxiety and depression Rating Scale- Depression subscale
time frame: Participants will be assessed at baseline and then end of therapy at 12 weeks
description: Measurement of depression
measure: Hospital Anxiety and Depression Scale, Anxiety subscale
time frame: Participants will be assessed at baseline and then end of therapy at 12 weeks
description: Measurement of anxiety
measure: Bradford Somatic Inventory
time frame: Participants will be assessed at baseline and then end of therapy at 12 weeks
description: Measurement of somatic symptoms
measure: Brief disability questionnaire
time frame: Participants will be assessed at baseline and then end of therapy at 12 weeks
description: To measure disability associated with depression
arm group label: Culturally adapted CBT based Self Help
arm group type: Experimental
description: Culturally sensitive cbt based self help intervention, which consists of 6 regular chapters and 2 additional chapters. The self help intervention involves family to improve compliance with the intervention
arm group label: Care As Usual
arm group type: No Intervention
description: Control Group
intervention type: Behavioral
intervention name: Culturally adapted CBT based Self Help
description: Intervention was based on our initial work using mixed methods, using mixed methods,in Pakistan. It focused on psycho-education, symptoms management, changing negative thinking, behavioral activation, problem solving, improving relationships and communication skills. One person from the family was involved in all cases. The intervention consists of 7 chapters. Manual can be used by the patient's or carers with at least 5 years of education. A member of the research team called them once every week to remind them of the next chapter and also to discuss any issues o problems that emerged during the previous week. This manual can be downloaded from PACT website (http://www.pactorganization.com/)
arm group label: Culturally adapted CBT based Self Help
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mehwish Khalid, MSc
role: Study Director
affiliation: PACT
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder