Brief Culturally Adapted Cognitive Behaviour Therapy for Depression

NCT01799551 | Completed DMC

• 1 other identifier: PakistanACT
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is recommended by the national bodies in many countries in the West. Our group has adapted CBT for depression and psychosis in Pakistan for use with local clients. Initial evaluations have found that these therapies are effective. However, due to the financial restraints it would be useful if the investigators find that brief version of the CBT might be applicable and effective in non western cultures. Therefore in this study, the investigators will be testing effectiveness of brief version of culturally adapted CBT for depression in a randomized controlled trial (RCT) in Pakistan.

Conditions

Depression

Keywords

Depression; Culture; CBT; Adaptation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospital Anxiety and Depression Scale, Anxiety subscale

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

• Bradford Somatic Inventory

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

• Brief disability questionnaire

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

Study Arms (2)

Ca CBT

ACTIVE COMPARATOR

Experimental arm will receive brief version of Culturally adapted CBT for depression. This is based on our previous work in which we adapted CBT for depression in Pakistan

Behavioral: Ca CBT

Treatment As Usual

NO INTERVENTION

Patients in this arm will get only Treatment As Usual, which normally includes regular follow up and medicines.

Interventions

Ca CBT BEHAVIORAL

Clients in intervention group will receive a CBT intervention using a manual. Intervention was developed for use in primary and secondary care using a series of qualitative studies (Naeem et al a, 2010, Naeem et al c, 2009, Naeem et al, 2009, Naeem et al, in press) during the last 5 years in Pakistan and has proven to be effective in a pilot study (Naeem et al, 2011). Intervention will consist of 6 sessions and will focus on psycho-education, symptoms management, changing negative thinking, problem solving, improving relationships and communication skills. One person from the family will be involved as a facilitator.

Also known as: Culturally adapted Brief Cognitive Behaviour Therapy

Ca CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All those who fulfil the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on interviews using SCAN Urdu version),
• Are between the ages of 19-60,
• Score 8 or more on HADS, Depression Subscale, and
• Who live within traveling distance of the psychiatry department will be approached

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Association of Cognitive Therapists: lead

Study Sites (1)

Pakistan Association of Cognitive Therapists

Lahore, Pakistan

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Farooq Naeem, MRCPsych,PhD

  Pakistan Association of Cognitive Therapists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Pakistan Association of Cognitive Therapists

Study Record Dates

• First Submitted: February 23, 2013
• First Posted: February 27, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

PA (1)