Feasibility and Efficacy Trial of a Culturally Adapted Guided Self-Help CBT Manual for OCD

NCT ID: NCT07239401

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-02-28

Brief Summary

This randomised controlled trial (RCT) aims to assess the feasibility, acceptability, and preliminary efficacy of a culturally adapted, guided self-help cognitive behaviour therapy (CBT) manual specifically designed for individuals with OCD in Pakistan.

Detailed Description

Obsessive-Compulsive Disorder (OCD) is a chronic and debilitating mental health condition characterised by persistent, intrusive thoughts (obsessions) and repetitive behaviours or mental acts (compulsions). These symptoms are often distressing, time-consuming, and cause significant functional impairment and reduction in quality of life. Cognitive and behavioural therapies, particularly the Exposure and Response Prevention (ERP), have consistently demonstrated efficacy as a first-line treatment for OCD. However, access to trained therapists remains limited in low- and middle-income countries (LMICs), including Pakistan.

Self-help interventions rooted in CBT principles, especially when culturally adapted, represent a promising, scalable, and cost-effective alternative to conventional therapy. Previous research in Pakistan has shown the feasibility and acceptability of culturally adapted CBT (CaCBT) in treating depression and OCD within primary care and outpatient settings (Naeem et al., 2011; Aslam et al., 2015).

This randomised controlled trial (RCT) aims to assess the feasibility, acceptability, and preliminary efficacy of a culturally adapted, guided self-help CBT manual specifically designed for individuals with OCD in Pakistan.

Conditions

Obsessive - Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Culturally adapted guided self-help OCD

Participants will receive a culturally adapted guided self-help OCD manual based on culturally adapted CBT principles, designed to be used over ten weeks. The manual includes: Psychoeducation, Exposure and Response Prevention (ERP), Thought distraction techniques, Mood tracking and thought diaries, Identifying and modifying cognitive distortions, Problem-solving and communication strategies, and Relaxation and well-being exercises. Participants will receive the self-help manual at the time of initial assessment and intake, and then will be provided with telephone support. Psychology graduates working as guides will provide weekly telephone support. Intervention will be provided flexibly over 12 weeks. The second contact will be made at the time of final assessment on the 12th week.

Group Type: EXPERIMENTAL

Culturally adapted Guided Self-Help OCD Manual

Intervention Type: OTHER

Participants will receive a culturally adapted guided self-help OCD manual based on culturally adapted CBT principles, designed to be used over ten weeks. The manual includes: Psychoeducation, Exposure and Response Prevention (ERP), Thought distraction techniques, Mood tracking and thought diaries, Identifying and modifying cognitive distortions, Problem-solving and communication strategies, and Relaxation and well-being exercises. Participants will receive the self-help manual at the time of initial assessment and intake, and then will be provided with telephone support. Psychology graduates working as guides will provide weekly telephone support. Intervention will be provided flexibly over 12 weeks. The second contact will be made at the time of final assessment on the 12th week.

Treatment as Usual (TAU)

Participants in the control group will receive standard outpatient care, which typically includes medication and brief consultation with psychiatrists or general practitioners. No formal psychological intervention will be offered during the study period. Pre-post assessment will be conducted over a 12-week span.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Culturally adapted Guided Self-Help OCD Manual

Participants will receive a culturally adapted guided self-help OCD manual based on culturally adapted CBT principles, designed to be used over ten weeks. The manual includes: Psychoeducation, Exposure and Response Prevention (ERP), Thought distraction techniques, Mood tracking and thought diaries, Identifying and modifying cognitive distortions, Problem-solving and communication strategies, and Relaxation and well-being exercises. Participants will receive the self-help manual at the time of initial assessment and intake, and then will be provided with telephone support. Psychology graduates working as guides will provide weekly telephone support. Intervention will be provided flexibly over 12 weeks. The second contact will be made at the time of final assessment on the 12th week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Clinical diagnosis of OCD (with or without comorbid depression)
• Minimum 5 years of formal education
• Residing within commuting distance of the participating sites
• Ability to read and write Urdu
• Provision of informed written consent

Exclusion Criteria

• Current substance use or dependence (diagnosed)
• Significant cognitive impairment (e.g., dementia or intellectual disability)
• OCD with active psychosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Association of Cognitive Therapists

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirrat Gul Butt, PhD

Role: PRINCIPAL_INVESTIGATOR

Pakistan Association of Cognitive Therapists

Other Identifiers

RCT_G_OCD_2025

Identifier Type: -

Identifier Source: org_study_id