Obsessive-Compulsive DisorderERP in SilicoNCT05520398
Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure
An observational study of Obsessive-Compulsive Disorder, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2021to 31 Dec 2025
- Phase
- Observational
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients diagnosed with obsessive-compulsive disorder (OCD)
Who may be able to join
- Diagnosis of obsessive-compulsive disorder (OCD)
- Fluent in written and spoken English
- Normal/corrected to normal vision
- Expecting to start OCD therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Max Planck UCL Centre for Computational Psychiatry and Ageing Research
London, WC1B 5EH
Karen Hoang, MSc, +44-(0)203-1087538, k.hoang@ucl.ac.uk
Tricia Seow, PhD, +44-(0)203-1087538, t.seow@ucl.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Medical subject headings
- Obsessive-Compulsive Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown obsessive compulsive scale (Y-BOCS)
The Y-BOCS is a 10-item scale used to assess symptom severity in OCD.
Measured: 3 - 9 months
Decision making and learning tasks
Computer-based behavioural task developed by the investigators to understand decision making in OCD.
Measured: 3 - 9 months
Secondary outcomes (10)
Patient EX/RP Adherence Scale (PEAS)
Self-report assessment for patient's therapy adherence.
Measured: 3 - 9 months
Short form of Obsessive Beliefs Questionnaire (OBQ)
Self-report assessment for obsessive beliefs.
Measured: 3 - 9 months
Brief Experiential Avoidance Questionnaire (BEAQ)
Self-report assessment for experiential avoidance.
Measured: 3 - 9 months
International Cognitive Ability Resource (ICAR16)
Measure to assess cognitive ability.
Measured: 3 - 9 months
Worry Domains Questionnaire - Short Form (WDQ-SF)
Self-report assessment for worry.
Measured: 3 - 9 months
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Self-report assessment for quality of life assessment.
Measured: 3 - 9 months
Sheehan Disability Scale (SDS)
Self-report assessment for functional impairment.
Measured: 3 - 9 months
State-Trait Anxiety Inventory (STAI)
Measure of trait and state anxiety
Measured: 3 - 9 months
Zung Self-Rating Depression Scale (SDS)
Self-report measure of depressive symptomatology.
Measured: 3 - 9 months
Anxiety Sensitivity Index (ASI-3)
Self-report measure for anxiety sensitivity symptomatology.
Measured: 3 - 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start10 Nov 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Hauser, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520398
- Sponsor's protocol ID
- 15/0541
- Acronym
- ERP in Silico
- Status last verified
- Dec 2024
- First submitted
- 26 Aug 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Neural Networks in Psychiatry (CNNP): Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure (ERP in Silico)
- ClinicalTrials.gov ID
- NCT05520398
- Acronym / sponsor ID
- ERP in Silico / 15/0541
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Aug 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with obsessive-compulsive disorder (OCD)
Key inclusion criteria (4 listed)
- Diagnosis of obsessive-compulsive disorder (OCD)
- Fluent in written and spoken English
- Normal/corrected to normal vision
- Expecting to start OCD therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Decision making and learning tasks
Time frame: 3 - 9 months
Computer-based behavioural task developed by the investigators to understand decision making in OCD.
10 secondary outcomes
Patient EX/RP Adherence Scale (PEAS)
Time frame: 3 - 9 months
Short form of Obsessive Beliefs Questionnaire (OBQ)
Time frame: 3 - 9 months
Brief Experiential Avoidance Questionnaire (BEAQ)
Time frame: 3 - 9 months
International Cognitive Ability Resource (ICAR16)
Time frame: 3 - 9 months
Worry Domains Questionnaire - Short Form (WDQ-SF)
Time frame: 3 - 9 months
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Time frame: 3 - 9 months
Sheehan Disability Scale (SDS)
Time frame: 3 - 9 months
State-Trait Anxiety Inventory (STAI)
Time frame: 3 - 9 months
Zung Self-Rating Depression Scale (SDS)
Time frame: 3 - 9 months
Anxiety Sensitivity Index (ASI-3)
Time frame: 3 - 9 months
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 19 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Tobias Hauser, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by University College, London at 1 site in United Kingdom.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Tricia Seow, PhD (+44-(0)203-1087538, t.seow@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown obsessive compulsive scale (Y-BOCS) (time frame: 3 - 9 months). The study lists 2 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 19 Dec 2024.