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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pakistan Association of Cognitive Therapists
ClinicalTrials.gov Identifier:
NCT01725932
First received: October 31, 2012
Last updated: June 16, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Depression
Behavioral: Culturally adapted CBT based Self Help

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Randomised Controlled Trial of Culturally Adapted CBT Based Self Help Manual for Depression in Pakistan

Resource links provided by NLM:


Further study details as provided by Pakistan Association of Cognitive Therapists:

Primary Outcome Measures:
  • Hospital Anxiety and depression Rating Scale- Depression subscale [ Time Frame: Participants will be assessed at baseline and then end of therapy at 12 weeks ] [ Designated as safety issue: No ]
    Measurement of depression


Secondary Outcome Measures:
  • Hospital Anxiety and Depression Scale, Anxiety subscale [ Time Frame: Participants will be assessed at baseline and then end of therapy at 12 weeks ] [ Designated as safety issue: No ]
    Measurement of anxiety

  • Bradford Somatic Inventory [ Time Frame: Participants will be assessed at baseline and then end of therapy at 12 weeks ] [ Designated as safety issue: No ]
    Measurement of somatic symptoms

  • Brief disability questionnaire [ Time Frame: Participants will be assessed at baseline and then end of therapy at 12 weeks ] [ Designated as safety issue: No ]
    To measure disability associated with depression


Enrollment: 192
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Culturally adapted CBT based Self Help
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
Behavioral: Culturally adapted CBT based Self Help
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/)
No Intervention: Care As Usual
Control Group

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725932

Sponsors and Collaborators
Pakistan Association of Cognitive Therapists
Investigators
Study Director: Mehwish Khalid, MSc PACT
  More Information

No publications provided

Responsible Party: Pakistan Association of Cognitive Therapists
ClinicalTrials.gov Identifier: NCT01725932     History of Changes
Other Study ID Numbers: PACT_SHCBTD_2012
Study First Received: October 31, 2012
Last Updated: June 16, 2013
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Pakistan Association of Cognitive Therapists:
culture, depression, cognitive therapy, behaviour therapy,

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014