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Completed

NCT Number: NCT01725932

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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/)

Primary outcomes

  1. Hospital Anxiety and depression Rating Scale- Depression subscale

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

    Measurement of depression

Secondary outcomes

  1. Hospital Anxiety and Depression Scale, Anxiety subscale

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

    Measurement of anxiety

  2. Bradford Somatic Inventory

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

    Measurement of somatic symptoms

  3. Brief disability questionnaire

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

    To measure disability associated with depression

Sponsors and collaborators

Lead sponsor

Pakistan Association of Cognitive Therapists

Other

Registry information

Official study title

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

Acronym: CaCBT_SH

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 14, 2012
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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