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NCT Number: NCT07239401

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

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.

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Key information

Conditions

Obsessive - Compulsive Disorder Anxiety Disorders Compulsive Personality Disorder Mental Disorders Obsessive-Compulsive Disorder Personality Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Obsessive-compulsive symptoms

    Time frame: 12 weeks

    As assessed through participants' scores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  2. Feasibility and acceptability

    Time frame: 12 weeks

    Feasibility and acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants.

  3. Clients' satisfaction

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Anxiety & depression

    Time frame: 12 weeks

    As assessed through participants' scores on the Hospital Anxiety and Depression Scale (HADS)

  2. Functionality

    Time frame: 12 weeks

    As assessed through participants' scores on the WHO Disability Assessment Schedule 2 (WHODAS 2)

Sponsors and collaborators

Lead sponsor

Pakistan Association of Cognitive Therapists

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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