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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797691
• Other study ID #: CBT Pashtu 1
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: August 15, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Peshawar Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Other:
• CaCBT
Culturally Adapted Cognitive Behaviour Therapy
• Medication/ Psychotherapy
Medication/ Psychotherapy used as usual

Locations

Country	Name	City	State
Pakistan	PRIME Foundation/ Lady Reading Hospital	Peshawar	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Peshawar Medical College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Schwartz Outcome Scale	At end of therapy	2 Months	No
Primary	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	No
Secondary	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	No
Secondary	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	No