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

Depression Clinical Trial

— CaCBT_SH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725932
• Other study ID #: PACT_SHCBTD_2012
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: June 16, 2013
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Pakistan Association of Cognitive Therapists
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

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/)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Association of Cognitive Therapists

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Hospital Anxiety and Depression Scale, Anxiety subscale	Measurement of anxiety	Participants will be assessed at baseline and then end of therapy at 12 weeks	No
Secondary	Bradford Somatic Inventory	Measurement of somatic symptoms	Participants will be assessed at baseline and then end of therapy at 12 weeks	No
Secondary	Brief disability questionnaire	To measure disability associated with depression	Participants will be assessed at baseline and then end of therapy at 12 weeks	No