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

NCT07239401 | Not Yet Recruiting

• 1 other identifier: RCT_G_OCD_2025
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obsessive - Compulsive Disorder

Keywords

OCD; Obsessive compulsive disorder; Guided self-help; CBT

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Anxiety & depression

  12 weeks

• Functionality

  12 weeks

Study Arms (2)

Culturally adapted guided self-help OCD

EXPERIMENTAL

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

Treatment as Usual (TAU)

NO INTERVENTION

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.

Interventions

Culturally adapted Guided Self-Help OCD Manual 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.

Culturally adapted guided self-help OCD

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pakistan Association of Cognitive Therapists: lead

MeSH Terms

Conditions

Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Anxiety Disorders

Study Officials

• Mirrat Gul Butt, PhD

  Pakistan Association of Cognitive Therapists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a rater-blind, randomised controlled trial (RCT) comparing a guided self-help CBT intervention plus Treatment as Usual (TAU) with TAU alone. Participants will be randomly assigned (1:1 allocation) to either group. Assessments will occur at baseline and 12 weeks post-intervention.

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: November 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share