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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Culturally adapted CBT based Self Help

• Registration Number: NCT01725932
• Lead Sponsor: Pakistan Association of Cognitive Therapists

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-14
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-16
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culturally adapted CBT based Self Help	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

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and depression Rating Scale- Depression subscale	Participants will be assessed at baseline and then end of therapy at 12 weeks	Measurement of depression

Secondary Outcome Measures

Name	Time	Method
Bradford Somatic Inventory	Participants will be assessed at baseline and then end of therapy at 12 weeks	Measurement of somatic symptoms
Hospital Anxiety and Depression Scale, Anxiety subscale	Participants will be assessed at baseline and then end of therapy at 12 weeks	Measurement of anxiety
Brief disability questionnaire	Participants will be assessed at baseline and then end of therapy at 12 weeks	To measure disability associated with depression