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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07239401
Enrollment
108
Registered
2025-11-20
Start date
2025-11-30
Completion date
2026-02-28
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive - Compulsive Disorder

Keywords

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

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.

Interventions

OTHERCulturally 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.

Sponsors

Pakistan Association of Cognitive Therapists
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Obsessive-compulsive symptoms12 weeksAs assessed through participants' scores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Feasibility and acceptability12 weeksFeasibility and acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants.
Clients' satisfaction12 weeksThe 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

MeasureTime frameDescription
Anxiety & depression12 weeksAs assessed through participants' scores on the Hospital Anxiety and Depression Scale (HADS)
Functionality12 weeksAs assessed through participants' scores on the WHO Disability Assessment Schedule 2 (WHODAS 2)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026