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

Obsessive-Compulsive Disorder Clinical Trial

— ERP in Silico  

Official title:

Cognitive and Neural Networks in Psychiatry (CNNP): Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure (ERP in Silico)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520398
• Other study ID #: 15/0541
• Status: Recruiting
• Start date: November 10, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: University College, London
• Contact: Karen Hoang, MSc
• Phone: +44-(0)203-1087538
• Email: k.hoang[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Locations

Country	Name	City	State
United Kingdom	Max Planck UCL Centre for Computational Psychiatry and Ageing Research	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown obsessive compulsive scale (Y-BOCS)	The Y-BOCS is a 10-item scale used to assess symptom severity in OCD.	3 - 9 months
Primary	Decision making and learning tasks	Computer-based behavioural task developed by the investigators to understand decision making in OCD.	3 - 9 months
Secondary	Patient EX/RP Adherence Scale (PEAS)	Self-report assessment for patient's therapy adherence.	3 - 9 months
Secondary	Short form of Obsessive Beliefs Questionnaire (OBQ)	Self-report assessment for obsessive beliefs.	3 - 9 months
Secondary	Brief Experiential Avoidance Questionnaire (BEAQ)	Self-report assessment for experiential avoidance.	3 - 9 months
Secondary	International Cognitive Ability Resource (ICAR16)	Measure to assess cognitive ability.	3 - 9 months
Secondary	Worry Domains Questionnaire - Short Form (WDQ-SF)	Self-report assessment for worry.	3 - 9 months
Secondary	The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)	Self-report assessment for quality of life assessment.	3 - 9 months
Secondary	Sheehan Disability Scale (SDS)	Self-report assessment for functional impairment.	3 - 9 months
Secondary	State-Trait Anxiety Inventory (STAI)	Measure of trait and state anxiety	3 - 9 months
Secondary	Zung Self-Rating Depression Scale (SDS)	Self-report measure of depressive symptomatology.	3 - 9 months
Secondary	Anxiety Sensitivity Index (ASI-3)	Self-report measure for anxiety sensitivity symptomatology.	3 - 9 months