Obsessive - Compulsive DisorderNCT07239401
Feasibility and Efficacy Trial of a Culturally Adapted Guided Self-Help CBT Manual for OCD
A study testing Culturally adapted Guided Self-Help OCD Manual in people with Obsessive - Compulsive Disorder, run by Pakistan Association of Cognitive Therapists.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive - Compulsive Disorder
- What is being tested?
- Culturally adapted Guided Self-Help OCD Manual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current substance use or dependence (diagnosed)
- Significant cognitive impairment (e.g., dementia or intellectual disability)
- OCD with active psychosis
About this study
Official title: 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.
Read the 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
- Being tested
- Culturally adapted Guided Self-Help OCD Manual
- Keywords
- OCD, Obsessive compulsive disorder, Guided self-help, CBT
- Medical subject headings
- Compulsive Personality Disorder, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted Guided Self-Help OCD ManualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive symptoms
As assessed through participants' scores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Measured: 12 weeks
Feasibility and acceptability
Feasibility and acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
Anxiety & depression
As assessed through participants' scores on the Hospital Anxiety and Depression Scale (HADS)
Measured: 12 weeks
Functionality
As assessed through participants' scores on the WHO Disability Assessment Schedule 2 (WHODAS 2)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive - Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Association of Cognitive Therapists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirrat Gul Butt, PhD, Principal investigator, Pakistan Association of Cognitive Therapists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239401
- Sponsor's protocol ID
- RCT_G_OCD_2025
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy Trial of a Culturally Adapted Guided Self-Help CBT Manual for Obsessive-Compulsive Disorder: A Randomised Controlled Study From Pakistan
- ClinicalTrials.gov ID
- NCT07239401
- Acronym / sponsor ID
- RCT_G_OCD_2025
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- OCD, Obsessive compulsive disorder, Guided self-help, CBT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Pakistan Association of Cognitive TherapistsUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted guided self-help OCD | Experimental | Other: Culturally adapted Guided Self-Help OCD ManualParticipants 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) | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Current substance use or dependence (diagnosed)
- Significant cognitive impairment (e.g., dementia or intellectual disability)
- OCD with active psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally adapted Guided Self-Help OCD ManualParticipants 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 |
Primary outcome
Obsessive-compulsive symptoms
Time frame: 12 weeks
As assessed through participants' scores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Feasibility and acceptability
Time frame: 12 weeks
Feasibility and acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants.
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.
2 secondary outcomes
Anxiety & depression
Time frame: 12 weeks
Functionality
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirrat Gul Butt, PhD principal investigator
Pakistan Association of Cognitive Therapists
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted Guided Self-Help OCD Manual in people with Obsessive - Compulsive Disorder, run by Pakistan Association of Cognitive Therapists.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive-compulsive symptoms (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.