- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232823
Brief Culturally Adapted CBT for OCD
Brief Culturally Adapted Cognitive Behaviour Therapy (CaCBT) for Obsessive-Compulsive Disorder: A Randomised Controlled Trial From Pakistan
Study Overview
Status
Intervention / Treatment
Detailed Description
The presence of obsessions and compulsions characterises obsessive-compulsive disorder (OCD). Obsessions are intrusive, unwanted thoughts, images, or impulses that are distressing and difficult to control. These obsessive thoughts cause significant emotional discomfort. Conversely, compulsions are repetitive behaviours or mental acts performed in response to an obsession or according to rigid rules. These actions are intended to reduce anxiety or prevent a feared event, even though they may not logically connect to the feared outcome. The individual often experiences temporary relief from distress through these ritualistic responses despite their lack of practical relevance to the obsessive fears.
Cognitive Behaviour Therapy (CBT) is widely recognised as a treatment option in both the US and UK National Treatment Guidelines (National Institute for Health and Care Excellence, 2009; American Psychiatric Association, 1993). There is strong evidence supporting CBT's effectiveness in treating, preventing relapse, and managing depression and anxiety (Embling, 2002; Fava et al., 1998; Paykel et al., 1999; Thase, 1997).
However, despite this evidence, there has been limited progress in assessing CBT's effectiveness in low and middle-income countries. CBT may require adaptation in non-Western cultures, as it involves exploring and modifying automatic thoughts and core beliefs (Padesky and Greenberger, 1995).
Preliminary research suggests that treatment manuals based on fundamental CBT principles are effective (Husain et al., 2013; Rahman et al., 2008; Sumathipala et al., 2008; Araya et al., 2003). In Pakistan, an adapted version of CBT for depression was conducted, demonstrating its effectiveness in primary care settings (Naeem et al., 2011). Similarly, a pilot study was conducted on brief culturally adapted cognitive behaviour therapy for obsessive-compulsive disorder (Aslam et al. 2015).
This study aims to conduct a randomised controlled trial using brief culturally adapted cognitive behaviour therapy for obsessive-compulsive disorder in Pakistan, as limited research is available on this aspect. Conducting this trial can provide valuable data on the effectiveness of culturally adapted CBT in the Pakistani cultural setting, informing both local and international practices.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Aslam
- Phone Number: +92 301 7170139
- Email: Muhammadaslam139@gmail.com
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Professional Association of Cognitive Therapy
-
Principal Investigator:
- Farooq Naeem
-
Contact:
- Muhammad Aslam, MSCP
- Phone Number: +92 301 7170139
- Email: Muhammadaslam139@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged 18 years or above
- Participants with at least an elementary level of reading and writing
- Clinical diagnosis of Obsessive Compulsive Disorder, either alone or comorbid with depression or anxiety
Exclusion Criteria:
- Participants with excessive use of alcohol or drugs (using ICD-10 RDC for alcohol or drug abuse or dependence)
- Those with significant cognitive impairment (for example, intellectual disability or dementia)
- Or those with OCD comorbid active psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief culturally adapted CBT (CaCBT) group
Participants in this group will receive the Culturally Adapted CBT (CaCBT) manual along with treatment as usual (which typically involves medication prescriptions and regular hospital visits).
The manual will focus on psychoeducation, symptom management, Exposure and Response prevention (ERP), thought distraction techniques, relaxation exercises, detection of mood and thoughts, cognitive errors, changing negative thinking, behavioural activation, problem solving, improving relationships and communication skills, Thought diaries and progress diary.
|
The intervention will focus on psychoeducation, symptom management, Exposure and Response prevention (ERP), thought distraction techniques, relaxation exercises, detection of mood and thoughts, cognitive errors, changing negative thinking, behavioural activation, problem solving, improving relationships and communication skills, Thought diaries and progress diary.
|
|
No Intervention: Treatment as usual group
Participants in this group will receive only treatment as usual (TAU), which typically involves medication prescriptions and regular hospital visits.
Research psychologists delivering the intervention will not be involved with participants allocated to TAU.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of brief culturally adapted cognitive behaviour therapy (CaCBT) for OCD
Time Frame: 6 weeks
|
By comparing pre- and post-treatment OCD scores measured through the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).
|
6 weeks
|
|
Acceptability of the brief culturally adapted cognitive behaviour therapy (CaCBT) for OCD
Time Frame: 6 weeks
|
Feedback will be taken from both patients and their family members, who will be trained as co-therapists, to evaluate their satisfaction with the therapy.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in depression and anxiety associated with OCD
Time Frame: 6 weeks
|
By comparing pre- and post-treatment depression and anxiety scores measured through the Hospital Anxiety and Depression Scale (HADS).
|
6 weeks
|
|
Reduction in functioning decline associated with OCD
Time Frame: 6 weeks
|
By comparing pre- and post-treatment scores on the Brief Disability Questionnaire (BDQ).
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Farooq Naeem, Professional Association of Cognitive Therapy
- Principal Investigator: Muhammad Aslam, Professional Association of Cognitive Therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CaCBTOCD24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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