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Completed

NCT Number: NCT02797691

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Infections Inflammation Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Suppuration

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PRIME Foundation/ Lady Reading Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CaCBT

Other

Culturally Adapted Cognitive Behaviour Therapy

Medication/ Psychotherapy

Other

Medication/ Psychotherapy used as usual

Primary outcomes

  1. Change in score of Hospital Anxiety and Depression Scale (HADS) from baseline to end of therapy

    Time frame: 2 Months

    At baseline and after end of therapy [after 6 Weekly Sessions (in almost 8 weeks time)]

Secondary outcomes

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

    Time frame: 2 Months

    At baseline and after end of therapy [after 6 Weekly Sessions (in almost 8 weeks time)]

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

    Time frame: 2 Months

    At baseline and after end of therapy [after 6 Weekly Sessions (in almost 8 weeks time)]

Other outcomes

  1. Schwartz Outcome Scale

    Time frame: 2 Months

    At end of therapy

Sponsors and collaborators

Lead sponsor

Peshawar Medical College

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 13, 2016
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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