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RecruitingNCT06646900Updated Oct 17, 2024

Feasibility and Acceptability Trial of a Culturally Adapted Manual Versus Standard CBT Manual: A Randomized Control Trial

An interventional study of Culturally adapted CBT (CaCBT) based guided self-help manual and Standard CBT Manual in Anxiety and Depression, sponsored by Pakistan Association of Cognitive Therapists. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Pakistan Association of Cognitive Therapists · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This randomized controlled trial (RCT) will compare the efficacy and feasibility and acceptability of a culturally adapted CBT manual with a standard CBT manual, focusing on addressing cultural factors in therapy delivery.

Read the detailed description

Randomized Controlled Trial (RCT): Participants will be randomly assigned to either the culturally adapted CBT manual group or the standard CBT manual group. A culturally adapted manual will integrate cultural values, norms, and idioms of suffering into CBT techniques, ensuring relevance and acceptance within the target cultural group. The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations.

02

Conditions studied

  • Anxiety
  • Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's planned enrollment of 200 is above the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Pakistan Association of Cognitive Therapists is the lead sponsor of 13 studies on the registry; 9 are open to participants now.

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

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Who can participate

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

Inclusion criteria

  1. Individuals aged 18 to 65 years
  2. 5 years of education
  3. Symptoms of depression and anxiety

Exclusion criteria

Exclusion Criteria:

  1. Substance use disorder according to DSM-5 criteria as determined by primary care clinician
  2. Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician
  3. Active psychosis as determined by their primary care clinician
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    culturally adapted CaCBT manual

    Behavioral: Culturally adapted CBT (CaCBT) based guided self-help manual

  • Experimental
    standard CBT manual

    Behavioral: Standard CBT Manual

Interventions

  • BehavioralCulturally adapted CBT (CaCBT) based guided self-help manual

    The intervention consists of seven modules including cognitive restructuring, problem solving, behavioural activation and conflict management. Three additional modules focus on interpersonal relationships, mental health wellbeing and self-care. Each module is delivered over one week. The intervention uses culturally appropriate stories, drawings, examples from local folklore and religious context to describe the concepts of CBT.

  • BehavioralStandard CBT Manual

    The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations

06

What researchers measure

Primary outcomes

  1. Feasibility and acceptability measures

    Feasibility and acceptability and Client's satisfaction will be measured through standardized measures of anxiety and depression

    Time frame: 12 weeks

  2. Clinical Measures

    Depression and Anxiety, measured by Hosptal and Anxiety Scale (HADS)

    Time frame: 12 weeks

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Study locations

1 of 1 sites recruiting
  • Pakistan Association of Cognitive Therapists
    Lahore, Punjab 54000, Pakistan
    Recruiting
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 Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06646900
Lead sponsor
Pakistan Association of Cognitive Therapists
Responsible party
Sponsor
First posted
Oct 17, 2024
Start date
Nov 20, 2024 (estimated)
Primary completion
Dec 10, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 17, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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