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

NCT ID: NCT02797691

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-07-31

Brief 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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CaCBT plus Treatment As Usual

Receiving "CaCBT intervention" in addition to the Treatment as usual

Group Type: EXPERIMENTAL

CaCBT

Intervention Type: OTHER

Culturally Adapted Cognitive Behaviour Therapy

Medication/ Psychotherapy

Intervention Type: OTHER

Medication/ Psychotherapy used as usual

Treatment As Usual (TAU)

Receiving Treatment as usual

Group Type: ACTIVE_COMPARATOR

Medication/ Psychotherapy

Intervention Type: OTHER

Medication/ Psychotherapy used as usual

Interventions

CaCBT

Culturally Adapted Cognitive Behaviour Therapy

Intervention Type: OTHER

Medication/ Psychotherapy

Medication/ Psychotherapy used as usual

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peshawar Medical College

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Irfan

Head, Department of Mental Health, Psychiatry and Behavioural Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Irfan, MCPS FCPS MS

Role: PRINCIPAL_INVESTIGATOR

Peshawar Medical College

Locations

PRIME Foundation/ Lady Reading Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

Other Identifiers

CBT Pashtu 1

Identifier Type: -

Identifier Source: org_study_id