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Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression (CaCBT_SH)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Culturally adapted CBT based Self Help
Sponsored by
Pakistan Association of Cognitive Therapists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring culture, depression, cognitive therapy, behaviour therapy,

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All those who fulfil the diagnosis of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (International Classification of Diseases, Research Diagnostic Criteria), scored 8 or more on HADS (Hospital Anxiety and Depression Scale) Depression Sub-scale, are between the ages of 18-60 and either patient or the carer has at least 5 years of education.

Exclusion Criteria:

  • The exclusion criteria include; excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Culturally adapted CBT based Self Help

    Care As Usual

    Arm 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

    Control Group

    Outcomes

    Primary Outcome Measures

    Hospital Anxiety and depression Rating Scale- Depression subscale
    Measurement of depression

    Secondary Outcome Measures

    Hospital Anxiety and Depression Scale, Anxiety subscale
    Measurement of anxiety
    Bradford Somatic Inventory
    Measurement of somatic symptoms
    Brief disability questionnaire
    To measure disability associated with depression

    Full Information

    First Posted
    October 31, 2012
    Last Updated
    June 16, 2013
    Sponsor
    Pakistan Association of Cognitive Therapists
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01725932
    Brief Title
    Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression
    Acronym
    CaCBT_SH
    Official Title
    A Multicentre Randomised Controlled Trial of Culturally Adapted CBT Based Self Help Manual for Depression in Pakistan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pakistan Association of Cognitive Therapists

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    culture, depression, cognitive therapy, behaviour therapy,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    192 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Culturally adapted CBT based Self Help
    Arm Type
    Experimental
    Arm 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 Title
    Care As Usual
    Arm Type
    No Intervention
    Arm Description
    Control Group
    Intervention Type
    Behavioral
    Intervention Name(s)
    Culturally adapted CBT based Self Help
    Intervention 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/)
    Primary Outcome Measure Information:
    Title
    Hospital Anxiety and depression Rating Scale- Depression subscale
    Description
    Measurement of depression
    Time Frame
    Participants will be assessed at baseline and then end of therapy at 12 weeks
    Secondary Outcome Measure Information:
    Title
    Hospital Anxiety and Depression Scale, Anxiety subscale
    Description
    Measurement of anxiety
    Time Frame
    Participants will be assessed at baseline and then end of therapy at 12 weeks
    Title
    Bradford Somatic Inventory
    Description
    Measurement of somatic symptoms
    Time Frame
    Participants will be assessed at baseline and then end of therapy at 12 weeks
    Title
    Brief disability questionnaire
    Description
    To measure disability associated with depression
    Time Frame
    Participants will be assessed at baseline and then end of therapy at 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All those who fulfil the diagnosis of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (International Classification of Diseases, Research Diagnostic Criteria), scored 8 or more on HADS (Hospital Anxiety and Depression Scale) Depression Sub-scale, are between the ages of 18-60 and either patient or the carer has at least 5 years of education. Exclusion Criteria: The exclusion criteria include; excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mehwish Khalid, MSc
    Organizational Affiliation
    PACT
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression

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