CClinicalTrials.gg
CompletedNCT02797691Updated Aug 16, 2016

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

An interventional study of CaCBT and Medication/ Psychotherapy in Depression, Anxiety, sponsored by Peshawar Medical College. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-16.

Sponsored by Peshawar Medical College · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depression, Anxiety

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Keywords

  • Cognitive Behavior Therapy
  • Depression
  • Anxiety
  • Pashto
  • Pakistani
  • Afghan
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 40 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Peshawar Medical College is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    CaCBT plus Treatment As Usual

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

    Other: CaCBT · Other: Medication/ Psychotherapy

  • Active comparator
    Treatment As Usual (TAU)

    Receiving Treatment as usual

    Other: Medication/ Psychotherapy

Interventions

  • OtherCaCBT

    Culturally Adapted Cognitive Behaviour Therapy

  • OtherMedication/ Psychotherapy

    Medication/ Psychotherapy used as usual

06

What researchers measure

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 \[after 6 Weekly Sessions (in almost 8 weeks time)\]

    Time frame: 2 Months

Secondary outcomes

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

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

    Time frame: 2 Months

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

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

    Time frame: 2 Months

Other outcomes

  1. Schwartz Outcome Scale

    At end of therapy

    Time frame: 2 Months

07

Study locations

1 site
  • PRIME Foundation/ Lady Reading Hospital
    Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02797691
Lead sponsor
Peshawar Medical College
Responsible party
Muhammad Irfan (Head, Department of Mental Health, Psychiatry and Behavioural Sciences, Peshawar Medical College) — Principal investigator
First posted
Jun 13, 2016
Start date
Jan 2016
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Aug 16, 2016

Study contacts

Muhammad Irfan, MCPS FCPS MS
principal investigator · Peshawar Medical College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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