Obsessive Compulsive DisorderNCT07011901
Precision Analytic Research Methods in OCD
A study testing Exposure and Response Prevention in people with Obsessive Compulsive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Psychiatric disorders characterized by compulsivity, such as obsessive-compulsive disorder (OCD), result in considerable functional impairment and many individuals do not respond to gold-standard treatments. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Exposure and Response Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2025to 31 Mar 2030
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be:
- between the ages 18-55 years old
- English-speaking
- right-handed
- able to provide consent
Who cannot join
- Individuals diagnosed with OCD will be excluded if:
- they meet diagnostic criteria for certain other psychiatric disorders
- are taking psychiatric medication or have received behavioral treatment for OCD within a certain timeframe
- if it is unsafe for them to participate in research
- Healthy control participants will be excluded if:
- they have a current psychiatric disorder
Show all 10Show fewer
- a lifetime history of certain psychiatric disorders
- are taking psychiatric medication or have in the past
- have a parent or sibling who has been diagnosed with OCD
- if it is unsafe for them to participate in research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Amy Rapp
About this study
Official title: Dissecting Neurocognitive Components of Compulsivity Using Computational Modeling and EEG
Psychiatric disorders characterized by compulsivity, such as obsessive-compulsive disorder (OCD), result in considerable functional impairment and many individuals do not respond to gold-standard treatments. Compulsivity has long been thought to occur due to exaggerated habits and reduced goal-directed control, although more recently, this conceptualization of compulsivity as an imbalance of two cognitive systems has been challenged as overly narrow. This study will recruit 100 individuals (50 adults diagnosed with OCD, 50 healthy controls) and leverage the measurement precision offered by theory-driven computational modeling in combination with electroencephalogram (EEG) to go beyond this binary theory of compulsivity, revealing how more complex interactions of neurocognitive subcomponents contribute to compulsivity-information that could ultimately lead to improved treatment personalization and clinical outcomes.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Exposure and Response Prevention
- Keywords
- Obsessive Compulsive Disorder, Exposure and response prevention, Cognitive Behavioral Therapy, Electroencephalogram
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and Response PreventionBehavioural
Exposure and response prevention (EX/RP) is the gold-standard behavioral treatment for OCD. It involves confronting the content of obsessions (distressing thoughts, images, or impulses) and resisting the urge to engage in compulsions (observable behaviors or mental acts that are repeated to reduce the anxiety/distress associated with compulsions).
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with OCD | Experimental | All participants diagnosed with Obsessive Compulsive Disorder (OCD) who enroll in this study will receive 17 sessions of exposure and response prevention, a specialized cognitive behavioral therapy for OCD, over the course of 10 weeks. Receives: Behavioral: Exposure and Response Prevention |
| Healthy controls | No intervention | Individuals who do not have a current or lifetime psychiatric diagnosis will not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale
A semi-structured clinician-administered instrument used to measure obsessions and compulsions separately over five dimensions (time consumed, distress, interference, degree of resistance, control). The range of scores for the Obsessions and Compulsions subscales is 0-20, and the range for the total score is 0-40. Higher scores indicate greater symptom severity, and a total score greater or equal to 16 is considered indicative of moderately severe OCD
Measured: Week 1, Week 5, Week 10
Secondary outcomes (4)
Obsessive Compulsive Inventory- Revised
An 18-item self-report measure to assess obsessions and compulsions that demonstrates good psychometric properties and has been used in other research as a transdiagnostic measure of compulsivity. The range of scores for the six subscales (Washing; Obsessing; Ordering; Checking; Neutralizing; Hoarding) is 0-12. The range for the total score is 0-60 and does not include the Hoarding subscale. Higher scores indicate greater symptom severity.
Measured: Week 1, Week 5, Week 10
Cambridge-Chicago Compulsivity Trait Scale
A 15-item self-report measure to assess compulsivity transdiagnostically that exhibits high internal consistency and excellent convergent validity with gold-standard measures of compulsive symptoms. The range for the total score is 0-45, with higher scores indicating greater symptom severity
Measured: Week 1, Week 5, Week 10
Self-Report Habit Index
A 12-item self-report measure of the repetition and automaticity of a behavior that exhibits high internal consistency and test-retest reliability. The range for the total score is 12-84, with higher scores indicating greater symptom severity.
Measured: Week 1, Week 5, Week 10
Dimensional Obsessive- Compulsive Scale
A 20-item self-report measure that assesses four of the most consistently replicated thematic dimensions of OCD symptoms (i.e., contamination, harm, symmetry, repugnant content). The DOCS demonstrates good to excellent internal consistency, validity, and sensitivity. The range of scores for the four subscales (Contamination; Harm; Unacceptable Thoughts; Symmetry) is 0-20, and the range for the total score is 0-80. Higher scores indicate greater symptom severity.
Measured: Week 1, Week 5, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start9 Jul 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (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 Icahn School of Medicine at Mount SinaiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amy Rapp, Icahn School of Medicine at Mount Sinai
- Investigators
- Amy Rapp, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011901
- Sponsor's protocol ID
- STUDY-24-01125
- Other IDs
- K23MH133997
- Status last verified
- Oct 2025
- First submitted
- 2 Jun 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting Neurocognitive Components of Compulsivity Using Computational Modeling and EEG
- ClinicalTrials.gov ID
- NCT07011901
- Acronym / sponsor ID
- STUDY-24-01125
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Exposure and response prevention, Cognitive Behavioral Therapy, Electroencephalogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 10 Jun 2025 (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.
Psychiatric disorders characterized by compulsivity, such as obsessive-compulsive disorder (OCD), result in considerable functional impairment and many individuals do not respond to gold-standard treatments. Compulsivity has long been thought to occur due to exaggerated habits and reduced goal-directed control, although more recently, this conceptualization of compulsivity as an imbalance of two cognitive systems has been challenged as overly narrow. This study will recruit 100 individuals (50 adults diagnosed with OCD, 50 healthy controls) and leverage the measurement precision offered by theory-driven computational modeling in combination with electroencephalogram (EEG) to go beyond this binary theory of compulsivity, revealing how more complex interactions of neurocognitive subcomponents contribute to compulsivity-information that could ultimately lead to improved treatment personalization and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with OCD | Experimental | Behavioral: Exposure and Response PreventionAll participants diagnosed with Obsessive Compulsive Disorder (OCD) who enroll in this study will receive 17 sessions of exposure and response prevention, a specialized cognitive behavioral therapy for OCD, over the course of 10 weeks. |
| Healthy controls | No intervention | –Individuals who do not have a current or lifetime psychiatric diagnosis will not receive any treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- between the ages 18-55 years old
- English-speaking
- right-handed
- able to provide consent
Key exclusion criteria (10 listed)
- they meet diagnostic criteria for certain other psychiatric disorders
- are taking psychiatric medication or have received behavioral treatment for OCD within a certain timeframe
- if it is unsafe for them to participate in research
- they have a current psychiatric disorder
- a lifetime history of certain psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure and Response PreventionExposure and response prevention (EX/RP) is the gold-standard behavioral treatment for OCD. It involves confronting the content of obsessions (distressing thoughts, images, or impulses) and resisting the urge to engage in compulsions (observable behaviors or mental acts that are repeated to reduce the anxiety/distress associated with compulsions). | Behavioural | Participants diagnosed with OCD |
Primary outcome
Yale Brown Obsessive Compulsive Scale
Time frame: Week 1, Week 5, Week 10
A semi-structured clinician-administered instrument used to measure obsessions and compulsions separately over five dimensions (time consumed, distress, interference, degree of resistance, control). The range of scores for the Obsessions and Compulsions subscales is 0-20, and the range for the total score is 0-40. Higher scores indicate greater symptom severity, and a total score greater or equal to 16 is considered indicative of moderately severe OCD
4 secondary outcomes
Obsessive Compulsive Inventory- Revised
Time frame: Week 1, Week 5, Week 10
Cambridge-Chicago Compulsivity Trait Scale
Time frame: Week 1, Week 5, Week 10
Self-Report Habit Index
Time frame: Week 1, Week 5, Week 10
Dimensional Obsessive- Compulsive Scale
Time frame: Week 1, Week 5, Week 10
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 23 Oct 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Obsessive Compulsive Disorder
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Treatment-refractory Obsessive-compulsive Disorder (trOCD)
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tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
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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.
Amy Rapp, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and Response Prevention in people with Obsessive Compulsive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 5 inclusion and 10 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 23 Oct 2025. 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 States. 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 Amy Rapp, Ph.D. (212-241-5288, OCDResearch@mssm.edu), 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 (time frame: Week 1, Week 5, Week 10). 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 23 Oct 2025.