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

NCT02797691 | Completed

• 1 other identifier: CBT Pashtu 1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Cognitive Behavior Therapy; Depression; Anxiety; Pashto; Pakistani; Afghan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in score of Bradford Somatic Inventory (BSI) from baseline to end of therapy

  2 Months

• Change in score of Brief Disability Questionnaire/ WHO DAS from baseline to end of therapy

  2 Months

Other Outcomes (1)

• Schwartz Outcome Scale

  2 Months

Study Arms (2)

CaCBT plus Treatment As Usual

EXPERIMENTAL

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

Other: CaCBT; Other: Medication/ Psychotherapy

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Receiving Treatment as usual

Other: Medication/ Psychotherapy

Interventions

CaCBT OTHER

Culturally Adapted Cognitive Behaviour Therapy

CaCBT plus Treatment As Usual

Medication/ Psychotherapy OTHER

Medication/ Psychotherapy used as usual

CaCBT plus Treatment As Usual; Treatment As Usual (TAU)

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 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.

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

• Peshawar Medical College: lead

Study Sites (1)

PRIME Foundation/ Lady Reading Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Suppuration

Interventions

Dosage Forms; Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Behavioral Disciplines and Activities

Study Officials

• Muhammad Irfan, MCPS FCPS MS

  Peshawar Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department of Mental Health, Psychiatry and Behavioural Sciences

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 13, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)