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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre Randomised Controlled Trial of Culturally Adapted CBT Based Self Help Manual for Depression in Pakistan

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Culturally adapted CBT based Self Help


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally adapted CBT based Self Help<br>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<br>* 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/)<br>|
| No Intervention: Care As Usual<br>Control Group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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culture, depression, cognitive therapy, behaviour therapy,