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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01725932
Acronym
CaCBT_SH
Enrollment
192
Registered
2012-11-14
Start date
2012-03-31
Completion date
2012-12-31
Last updated
2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

culture, depression, cognitive therapy, behaviour therapy,

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.

Interventions

BEHAVIORALCulturally 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/)

Sponsors

Pakistan Association of Cognitive Therapists
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety and depression Rating Scale- Depression subscaleParticipants will be assessed at baseline and then end of therapy at 12 weeksMeasurement of depression

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale, Anxiety subscaleParticipants will be assessed at baseline and then end of therapy at 12 weeksMeasurement of anxiety
Bradford Somatic InventoryParticipants will be assessed at baseline and then end of therapy at 12 weeksMeasurement of somatic symptoms
Brief disability questionnaireParticipants will be assessed at baseline and then end of therapy at 12 weeksTo measure disability associated with depression

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026