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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06646900
Enrollment
200
Registered
2024-10-17
Start date
2024-11-20
Completion date
2024-12-31
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Brief 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.

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.

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

Sponsors

Pakistan Association of Cognitive Therapists
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This will be a randomized controlled trial to evaluate the feasibility and acceptability of delivering a new intervention. Participants who meet the inclusion criteria will be randomly allocated to intervention or control groups in a 1:1 ratio.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and acceptability measures12 weeksFeasibility and acceptability and Client's satisfaction will be measured through standardized measures of anxiety and depression
Clinical Measures12 weeksDepression and Anxiety, measured by Hosptal and Anxiety Scale (HADS)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026