Developing and Testing of Culturally Adapted Cognitive Behavior Therapy (CaCBT) for Pashto Speaking Pakistanis and Afghans

CBT for common mental disorders has a strong evidence base in both the USA and the UK. There are wider cultural and linguistic differences between Non Pashtun and Pashtun population of Pakistan and Afghanistan and there is evidence from research to suggest that CBT might need some adaptations when working with clients from non-western background. This study, thus, aims to culturally adapt CBT for common mental disorders for Pashto speaking population in Pakistan and Afghanistan and to test the effectiveness of this adapted CBT through a small scale pilot study.

The study will be carried out using mixed methods; quantitative and qualitative. Qualitative part will consist of structured interview with a minimum of 10-15 patients; carers; and mental health professionals, respectively, using the interview questionnaires. The data will be analysed by systematic content and question analysis which will identify the emerging themes and categories. The data will then be reorganized into wider themes and categories and written for guidelines to culturally adapt therapy manual for common mental disorders.

Quantitative phase will be a RCT involving 40 patients (20 in each arm) to assess the effectiveness of a "CaCBT intervention" for Pashto speaking patients. All those who fulfill the diagnostic criteria of depressive episode or recurrent depressive disorder using ICD 10 RDC, are living near or can easily travel to the psychiatry departments in Peshawar, will be included in the study.

The intervention group of the RCT will receive CaCBT intervention in addition to the treatment as usual (TAU) while the control group receives TAU. The assessment will be carried out at base-line and at the end of therapy (8-12 weeks). Bradford Somatic Inventory (BSI), Hospital Anxiety and Depression Scale (HADS) and Brief Disability Questionnaire (BDQ)/ WHO DAS will be used to measure somatic symptoms, anxiety, depression and disability due to physical and psychological problems, respectively. Schwartz Outcome Scale will be used at follow up to measure the outcome.

Study Overview

• Status: Completed
• Conditions: Depression, Anxiety
• Intervention / Treatment: Other: CaCBT; Other: Medication/ Psychotherapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
      • PRIME Foundation/ Lady Reading Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All those who fulfill the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4) or Anxiety disorder using ICD10 RDC and who live within travelling distance of the psychiatry department in Peshawar will be approached. Those patients, who have agreed to enter the study, will be assessed 2 weeks later, to fill in the baseline measures when they attend their first appointment. Patients will be asked to attend a further appointment at the end of study period and will be assessed again.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CaCBT plus Treatment As Usual; Receiving "CaCBT intervention" in addition to the Treatment as usual	Other: CaCBT; Culturally Adapted Cognitive Behaviour Therapy; Other: Medication/ Psychotherapy; Medication/ Psychotherapy used as usual
Active Comparator: Treatment As Usual (TAU); Receiving Treatment as usual	Other: Medication/ Psychotherapy; Medication/ Psychotherapy used as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score of Hospital Anxiety and Depression Scale (HADS) from baseline to end of therapy	At baseline and after end of therapy [after 6 Weekly Sessions (in almost 8 weeks time)]	2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score of Bradford Somatic Inventory (BSI) from baseline to end of therapy	At baseline and after end of therapy [after 6 Weekly Sessions (in almost 8 weeks time)]	2 Months
Change in score of Brief Disability Questionnaire/ WHO DAS from baseline to end of therapy	At baseline and after end of therapy [after 6 Weekly Sessions (in almost 8 weeks time)]	2 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schwartz Outcome Scale	At end of therapy	2 Months

Collaborators and Investigators

• Sponsor: Peshawar Medical College
• Investigators: Principal Investigator: Muhammad Irfan, MCPS FCPS MS, Peshawar Medical College

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 13, 2016

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Cognitive Behavior Therapy; Pashto; Pakistani; Afghan
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: CBT Pashtu 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No