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

NCT06646900 | Recruiting

• 1 other identifier: PACTMN24
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• Feasibility and acceptability measures

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

  12 weeks

• Clinical Measures

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

  12 weeks

Study Arms (2)

culturally adapted CaCBT manual

EXPERIMENTAL

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

standard CBT manual

EXPERIMENTAL

Behavioral: Standard CBT Manual

Interventions

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

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.

culturally adapted CaCBT manual

Standard CBT Manual BEHAVIORAL

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

standard CBT manual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 to 65 years
• years of education
• Symptoms of depression and anxiety

You may not qualify if:

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

Sponsors & Collaborators

• Pakistan Association of Cognitive Therapists: lead

Study Sites (1)

Pakistan Association of Cognitive Therapists

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: October 17, 2024
• Study Start: November 20, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 31, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)