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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02797691
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Muhammad Irfan, Peshawar Medical College

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.


Condition or disease Intervention/treatment Phase
Depression, Anxiety Other: CaCBT Other: Medication/ Psychotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing and Testing of Culturally Adapted Cognitive Behavior Therapy (CaCBT) for Pashto Speaking Pakistanis and Afghans
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Schwartz Outcome Scale [ Time Frame: 2 Months ]
    At end of therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797691


Locations
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Pakistan
PRIME Foundation/ Lady Reading Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
Sponsors and Collaborators
Peshawar Medical College
Investigators
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Principal Investigator: Muhammad Irfan, MCPS FCPS MS Peshawar Medical College

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Responsible Party: Muhammad Irfan, Head, Department of Mental Health, Psychiatry and Behavioural Sciences, Peshawar Medical College
ClinicalTrials.gov Identifier: NCT02797691     History of Changes
Other Study ID Numbers: CBT Pashtu 1
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Muhammad Irfan, Peshawar Medical College:
Cognitive Behavior Therapy
Depression
Anxiety
Pashto
Pakistani
Afghan

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms