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

October 16, 2024 updated by: Pakistan Association of Cognitive Therapists
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Pakistan Association of Cognitive Therapists
        • Contact:
        • Principal Investigator:
          • Farooq Naeem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: culturally adapted CaCBT manual
Behavioral: Culturally 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.
Experimental: standard CBT manual
Behavioral: Standard CBT Manual
The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability measures
Time Frame: 12 weeks
Feasibility and acceptability and Client's satisfaction will be measured through standardized measures of anxiety and depression
12 weeks
Clinical Measures
Time Frame: 12 weeks
Depression and Anxiety, measured by Hosptal and Anxiety Scale (HADS)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Association of Cognitive Therapists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2024

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACTMN24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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