Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure

Recruiting

• Conditions: Obsessive-Compulsive Disorder

• Registration Number: NCT05520398
• Lead Sponsor: University College, London

Brief Summary

The aim of this study is to understand why patients with obsessive-compulsive disorder (OCD) fail in therapy.

To understand the neural mechanisms involved in exposure therapy that support success and clinical improvement in order to improve therapy outcomes for OCD patients.

Detailed Description

A course of therapy is recommended for individuals with obsessive-compulsive disorder (OCD). It is usually a type of cognitive behavioural therapy (CBT) with exposure and response prevention (ERP).

In this study the investigators assess patients pre-therapy and post-therapy evaluating symptom severity (measured by the Y-BOCS) and decision-making (measured by online questionnaires and computer-based behavioural tasks).

To examine how decisions are formed in patients undergoing OCD CBT, how behaviour changes after a non-pharmacological therapy module and how it is associated to the alleviation of OCD symptoms.

The study, which will recruit 90 patients, is based at University College London - Wellcome Centre for Human Neuroimaging. This study is a part of the Cognitive and Neural Networks in Psychiatry (CNNP) study.

Study Timeline

• Study Start: 2021-11-10
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Diagnosis of obsessive-compulsive disorder (OCD)
• Fluent in written and spoken English
• Normal/corrected to normal vision
• Expecting to start OCD therapy

Exclusion Criteria

• Autism spectrum disorder, psychosis, schizophrenia, addiction, substance abuse, bipolar, hoarding, or Tourette disorder
• Hearing conditions: tinnitus, ear inflammation, hearing sensitivity, hearing loss, requires hearing aids
• Colour blindness
• Severe learning disabilities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Yale-Brown obsessive compulsive scale (Y-BOCS)	3 - 9 months	The Y-BOCS is a 10-item scale used to assess symptom severity in OCD.
Decision making and learning tasks	3 - 9 months	Computer-based behavioural task developed by the investigators to understand decision making in OCD.

Secondary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI)	3 - 9 months	Measure of trait and state anxiety
Zung Self-Rating Depression Scale (SDS)	3 - 9 months	Self-report measure of depressive symptomatology.
Patient EX/RP Adherence Scale (PEAS)	3 - 9 months	Self-report assessment for patient's therapy adherence.
International Cognitive Ability Resource (ICAR16)	3 - 9 months	Measure to assess cognitive ability.
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)	3 - 9 months	Self-report assessment for quality of life assessment.
Sheehan Disability Scale (SDS)	3 - 9 months	Self-report assessment for functional impairment.
Brief Experiential Avoidance Questionnaire (BEAQ)	3 - 9 months	Self-report assessment for experiential avoidance.
Short form of Obsessive Beliefs Questionnaire (OBQ)	3 - 9 months	Self-report assessment for obsessive beliefs.
Worry Domains Questionnaire - Short Form (WDQ-SF)	3 - 9 months	Self-report assessment for worry.
Anxiety Sensitivity Index (ASI-3)	3 - 9 months	Self-report measure for anxiety sensitivity symptomatology.

Trial Locations

Locations (1)

Max Planck UCL Centre for Computational Psychiatry and Ageing Research; 🇬🇧 London, United Kingdom