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

NCT01725932 | Completed DMC

• 1 other identifier: PACT_SHCBTD_2012
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Keywords

culture, depression, cognitive therapy, behaviour therapy,

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and depression Rating Scale- Depression subscale

  Measurement of depression

  Participants will be assessed at baseline and then end of therapy at 12 weeks

Secondary Outcomes (3)

• Hospital Anxiety and Depression Scale, Anxiety subscale

  Participants will be assessed at baseline and then end of therapy at 12 weeks

• Bradford Somatic Inventory

  Participants will be assessed at baseline and then end of therapy at 12 weeks

• Brief disability questionnaire

  Participants will be assessed at baseline and then end of therapy at 12 weeks

Study Arms (2)

Culturally adapted CBT based Self Help

EXPERIMENTAL

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

Care As Usual

NO INTERVENTION

Control Group

Interventions

Culturally adapted CBT based Self Help BEHAVIORAL

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/)

Culturally adapted CBT based Self Help

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Association of Cognitive Therapists: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mehwish Khalid, MSc

  PACT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 14, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 18, 2013

Record last verified: 2013-06