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

Feasibility and Efficacy Trial of a Culturally Adapted Guided Self-Help CBT Manual for Obsessive-Compulsive Disorder: A Randomised Controlled Study From Pakistan

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obsessive - Compulsive Disorder
• Intervention / Treatment: Other: Culturally adapted Guided Self-Help OCD Manual

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obsessive-compulsive symptoms	As assessed through participants' scores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)	12 weeks
Feasibility and acceptability	Feasibility and acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants.	12 weeks
Clients' satisfaction	The client satisfaction scale will be used. At the end of the intervention, researchers will ask participants to describe their experience. They will be asked to name the sessions they found most or least helpful and to provide suggestions for improving the intervention.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety & depression	As assessed through participants' scores on the Hospital Anxiety and Depression Scale (HADS)	12 weeks
Functionality	As assessed through participants' scores on the WHO Disability Assessment Schedule 2 (WHODAS 2)	12 weeks

Collaborators and Investigators

• Sponsor: Pakistan Association of Cognitive Therapists
• Investigators: Principal Investigator: Mirrat Gul Butt, PhD, Pakistan Association of Cognitive Therapists

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: OCD; CBT; Obsessive compulsive disorder; Guided self-help
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: RCT_G_OCD_2025

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