- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05520398
Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure (ERP in Silico)
Cognitive and Neural Networks in Psychiatry (CNNP): Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure (ERP in Silico)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tricia Seow, PhD
- Phone Number: +44-(0)203-1087538
- Email: t.seow@ucl.ac.uk
Study Locations
-
-
-
London, United Kingdom, WC1B 5EH
- Recruiting
- Max Planck UCL Centre for Computational Psychiatry and Ageing Research
-
Contact:
- Karen Hoang, MSc
- Phone Number: +44-(0)203-1087538
- Email: k.hoang@ucl.ac.uk
-
Contact:
- Tricia Seow, PhD
- Phone Number: +44-(0)203-1087538
- Email: t.seow@ucl.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Yale-Brown obsessive compulsive scale (Y-BOCS)
Time Frame: 3 - 9 months
|
The Y-BOCS is a 10-item scale used to assess symptom severity in OCD.
|
3 - 9 months
|
|
Decision making and learning tasks
Time Frame: 3 - 9 months
|
Computer-based behavioural task developed by the investigators to understand decision making in OCD.
|
3 - 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient EX/RP Adherence Scale (PEAS)
Time Frame: 3 - 9 months
|
Self-report assessment for patient's therapy adherence.
|
3 - 9 months
|
|
Short form of Obsessive Beliefs Questionnaire (OBQ)
Time Frame: 3 - 9 months
|
Self-report assessment for obsessive beliefs.
|
3 - 9 months
|
|
Brief Experiential Avoidance Questionnaire (BEAQ)
Time Frame: 3 - 9 months
|
Self-report assessment for experiential avoidance.
|
3 - 9 months
|
|
International Cognitive Ability Resource (ICAR16)
Time Frame: 3 - 9 months
|
Measure to assess cognitive ability.
|
3 - 9 months
|
|
Worry Domains Questionnaire - Short Form (WDQ-SF)
Time Frame: 3 - 9 months
|
Self-report assessment for worry.
|
3 - 9 months
|
|
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Time Frame: 3 - 9 months
|
Self-report assessment for quality of life assessment.
|
3 - 9 months
|
|
Sheehan Disability Scale (SDS)
Time Frame: 3 - 9 months
|
Self-report assessment for functional impairment.
|
3 - 9 months
|
|
State-Trait Anxiety Inventory (STAI)
Time Frame: 3 - 9 months
|
Measure of trait and state anxiety
|
3 - 9 months
|
|
Zung Self-Rating Depression Scale (SDS)
Time Frame: 3 - 9 months
|
Self-report measure of depressive symptomatology.
|
3 - 9 months
|
|
Anxiety Sensitivity Index (ASI-3)
Time Frame: 3 - 9 months
|
Self-report measure for anxiety sensitivity symptomatology.
|
3 - 9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tobias Hauser, PhD, University College, London
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
- 15/0541
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.
Clinical Trials on Obsessive-Compulsive Disorder
-
Shanghai Pudong New Area Mental Health Center,...RecruitingObsessive Compulsive Disorder (OCD) | Obsessive - Compulsive DisorderChina
-
National Institute of Mental Health, Czech RepublicRecruitingObsessive-compulsive DisorderCzechia
-
ASST Fatebenefratelli SaccoFondazione IRCCS San Gerardo dei Tintori; Istittuo ricerca carattere Sceintifico...Enrolling by invitationObsessive - Compulsive DisorderItaly
-
Assiut UniversityNot yet recruitingSubstance Use | Substance Abuse Disorder | Obsessive Compulsive Disorder (OCD) | Obsessive Compulsive Behavior | Obsessive - Compulsive Disorder
-
Shanghai Mental Health CenterNot yet recruitingObsessive - Compulsive DisorderChina
-
Adam FrankRecruitingObsessive - Compulsive DisorderUnited States
-
Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
-
Mehmet Emrah KaradereGoztepe Prof Dr Suleyman Yalcın City HospitalRecruitingOCD | Obsessive - Compulsive DisorderTurkey (Türkiye)
-
Taipei Veterans General Hospital, TaiwanRecruitingObsessive-Compulsive Disorder (OCD)Taiwan
-
VU University of AmsterdamUniversity of Bern; Stockholm University; Thomas More University of Applied SciencesNot yet recruitingObsessive Compulsive Disorder (OCD)Sweden, Belgium, Netherlands, Switzerland