Obsessive-Compulsive DisorderOCRDNCT05377125
Neural Mechanisms of Response Inhibition Training for OCRD
A study testing Computerized cognitive training in people with Obsessive-Compulsive Disorder and Tricholemmoma, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
The impaired ability to suppress an inappropriate but pre-potent response (response inhibition; RI) characterizes several debilitating clinical problems, including obsessive-compulsive and related disorders (OCRD) such as obsessive-compulsive disorder, trichotillomania, and skin picking disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Tricholemmoma, Skin-Picking
- What is being tested?
- Computerized cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 31 Aug 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 60
- moderate level of OCRD symptoms (Yale-Brown Obsessive Compulsive Scale total ≥ 16, Massachusetts General Hospital-Hair pulling Scale total ≥ 12, or Skin Picking Scale-Revised total ≥ 7)
- a primary diagnosis of OCRD (i.e., OCD, TTM, or SPD)
- estimated IQ > 80
- presence of a RI deficits (SSRT ≥ 215ms).
Who cannot join
- Current substance use disorder
- Severe ADHD
- Lifetime diagnosis of psychotic disorder, bipolar disorder, or schizophrenia
- Current psychotherapy
- Change in psychotropic medication status within 8 weeks before the study or during the study
- Use of stimulant medication
- Active suicidal risk
- Contraindications for MRI procedures
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
UWM Anxiety Disorders Laboratory
Milwaukee, Wisconsin, 53211
Halle Berres, B.A., 262-364-6249, ocd-research@uwm.edu
Hanjoo Lee, Ph.D., 414-229-5858, leehj@uwm.edu
About this study
Official title: Neural Mechanisms of Response Inhibition Training for Obsessive-Compulsive Disorder and Related Conditions
The impaired ability to suppress an inappropriate but pre-potent response (response inhibition; RI) characterizes several debilitating clinical problems, including obsessive-compulsive and related disorders (OCRD) such as obsessive-compulsive disorder, trichotillomania, and skin picking disorder. There is a critical need to develop an effective and durable treatment for OCRDs with demonstrable evidence for improving impaired RI. The purpose of our project is to examine the impact of a novel computerized intervention, response inhibition training (RIT), on neural indices of RI, and examine the mechanistic link between engagement of the neural RI targets and change in OCRD symptoms. To this end, this project will conduct a randomized clinical trial for individuals with OCD, trichotillomania, and/or skin picking disorders. Participants will be randomly assigned to 8 to 16 sessions of computerized RIT or a computerized placebo training. Various clinical, behavioral, and brain-imaging data will be acquired to evaluate the training effects at baseline, post-training, and 1-month follow-up periods.
Read the detailed description
Research has documented abnormal inhibition-related brain activity as well as impaired behavioral performance of RI in OCRD. Despite the growing evidence suggesting a RI deficit as a fundamental process in OCRD, no validated treatment exists that can directly alter RI deficits and in turn ameliorate OCRD symptoms. It is vital to develop a highly specific intervention that precisely engages a theoretically and empirically well-grounded target such as RI deficits, to significantly improve the efficacy of our intervention efforts. The overarching goal of this study is to examine whether the computerized cognitive training program can improve the neural indicators of the ability to inhibit inappropriate responses, and produce a clinically meaningful level of reduction in obsessive-compulsive disorder and related symptoms. Our central hypothesis is that cognitive training designed to enhance RI will improve neural indices: fronto-basal ganglia circuitry, especially right inferior frontal cortex of RI among individuals with OCRDs. We also hypothesize that the change in the RI neural circuit will mediate the consequent clinical improvements in OCRD symptomatology.
Phase I (R61) will aim to examine change in neural RI indices via the RIT intervention, Adults diagnosed with OCRD problems (OCD, TTM, or SPD) will be randomly assigned to the RIT or placebo control (PLT) condition. At pre- and post-training, neurobehavioral measures of RI will be taken, including the Stop-Signal Task (SST) assessing SSRT and fMRI task assessing rIFC activation. Each RIT participant will continue with the training within the range of 8 to 16 sessions until the criterion-level change in SSRT is attained (based on the ongoing SSRT estimation), with the PLT group receiving comparable levels of training. We will also collect 1-month follow-up data on functional outcomes in order to obtain information on the effect of the intervention on the OCRD symptom indices.
Phase II (R33) is identical to Phase I in the overall study procedures. Adults diagnosed with OCRD problems will be assigned to RIT or PLT. Analytic focus will be on the reduction in OCRD symptoms and their potential mediational pathway (rather than the change in the neural RI indices, which is the primary analytic focus in Phase I). Other than these differences, the overall flow and procedures of the study will be identical between Phases I and II.
The key assessments will include the fMRI tasks of the RI processes and clinician-administered measures of OCRD symptoms. There are other self-reported, computerized, and clinician-administered measures that will be administered across various points over the course of the study.
- Conditions
- Obsessive-Compulsive Disorder, Tricholemmoma, Skin-Picking
- Being tested
- Computerized cognitive training, Computerized placebo training
- Keywords
- OCD; Trichotillomania; Excoriation; Response Inhibition
- Medical subject headings
- Obsessive-Compulsive Disorder, Excoriation Disorder, Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive trainingBehavioural
This intervention offers 45-minute computerized training sessions to each participant. This intervention aims to improve the individual's RI capabilities. All participants will receive 8 to 16 sessions after being randomized to this condition.
Computerized placebo trainingBehavioural
This intervention offers 45-minute computerized placebo cognitive training sessions to each participant. This intervention aims to exert no focused training on RI capabilities. All participants will receive 8 to 16 sessions after being randomized to this condition.
| Study group | Role | What they receive |
|---|---|---|
| Response Inhibition Training (RIT) | Experimental | Response Inhibition Training (RIT) is a about 40-level computer game designed to offer systematic practice of RI. Participants use the computer keyboard and mouse to respond to the demands of trials that are designed to offer training on response inhibition abilities, including suppressing pre-potent but irrelevant stimuli and responses. Each training session will last approximately 45 minutes. All participants will be offered a minimum of 8 sessions. Throughout training, we will continually monitor their behavioral RI index (= stop signal reaction time; SSRT) using a stop-signal task. If a participant's Index SSRT fails to reach a criterion-level reduction (i.e., approximately 1 SD) after the standard 8 session intervention, the RIT intervention will be extended up to 16 sessions until the criterion-level improvement in behavioral RI is attained. Receives: Behavioral: Computerized cognitive training |
| Placebo Training (PLT) | Placebo comparator | This training condition is designed to serve as an appropriate control condition for RIT, by providing no active ingredient of RI training components, while maintaining the overall training materials and structure similar. Similar to RIT, PLT uses the same task materials and a similar 40-level game structure. However, PLT will present simple RI-irrelevant visual judgment tasks to avoid changing RI-relate processes. The number of 45-min training sessions will be determined by their counterpart RIT participants through a yoked-control design. Receives: Behavioral: Computerized placebo training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in obsessive-compulsive disorder symptom severity over time
Depending on participant's primary diagnostic condition, Yale-Brown Obsessive Compulsive Scale (YBOCS) will be used as the primary outcome measure for assessing the change in OCD symptoms over time.
The total score ranges between 0 and 40 with higher scores indicating worse outcomes (= more severe symptoms).
Measured: Week 0, Week 4, Week 8 ~ 12
Change in compulsive hair pulling symptom severity over time
Depending on participant's primary diagnostic condition, National Institute of Mental Health - Trichotillomania Symptom Severity Scale (NIMH-TSS) will be used as the primary outcome measure for assessing the change in hair pulling symptoms over time.
The total score ranges between 0 and 25 with higher scores indicating worse outcomes (= more severe symptoms).
Measured: Week 0, Week 4, Week 8 ~ 12
Change in compulsive skin picking symptom severity over time
Depending on participant's primary diagnostic condition, Yale-Brown Obsessive Compulsive Scale modified for Neurotic Excoriation (NE-YBOCS) will be used as the primary outcome measure for assessing the change in skin picking symptoms over time.
The total score ranges between 0 and 40 with higher scores indicating worse outcomes (= more severe symptoms).
Measured: Week 0, Week 4, Week 8 ~ 12
Change in activation in the right inferior frontal cortex (rIFC)
Change in the level of blood-oxygen-level-dependent (BOLD) signal activation in the right inferior frontal cortex (rIFC) will be assessed using the stop-signal task (SST) that will be administered while the participant undergoes a functional magnetic resonance imaging procedure.
Measured: Week 0, Week 4
Secondary outcomes (1)
Change in the Clinical Global Impression Scale
The Clinical Global Impression Scale (CGI-I) is a clinician-administered rating scale on the overall improvement of the participant's condition throughout treatment.
The rating score ranges between 1 and 8 with higher scores indicating worse outcomes (= more severe symptoms).
Measured: Week 0, Week 4, Week 8 ~ 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start22 Dec 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of the two training groups in parallel for the duration of the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanjoo Lee, Ph.D., Principal investigator, University of Wisconsin, MilwaukeeChristine Larson, Ph.D., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377125
- Sponsor's protocol ID
- PRO00042324
- Acronym
- OCRD
- Status last verified
- Jul 2026
- First submitted
- 5 May 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Response Inhibition Training for Obsessive-Compulsive Disorder and Related Conditions
- ClinicalTrials.gov ID
- NCT05377125
- Acronym / sponsor ID
- OCRD / PRO00042324
- Conditions
- Obsessive-Compulsive Disorder, Tricholemmoma, Skin-Picking
- Keywords
- OCD; Trichotillomania; Excoriation; Response Inhibition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 May 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 impaired ability to suppress an inappropriate but pre-potent response (response inhibition; RI) characterizes several debilitating clinical problems, including obsessive-compulsive and related disorders (OCRD) such as obsessive-compulsive disorder, trichotillomania, and skin picking disorder. There is a critical need to develop an effective and durable treatment for OCRDs with demonstrable evidence for improving impaired RI. The purpose of our project is to examine the impact of a novel computerized intervention, response inhibition training (RIT), on neural indices of RI, and examine the mechanistic link between engagement of the neural RI targets and change in OCRD symptoms. To this end, this project will conduct a randomized clinical trial for individuals with OCD, trichotillomania, and/or skin picking disorders. Participants will be randomly assigned to 8 to 16 sessions of computerized RIT or a computerized placebo training. Various clinical, behavioral, and brain-imaging data will be acquired to evaluate the training effects at baseline, post-training, and 1-month follow-up periods.
Detailed description
Research has documented abnormal inhibition-related brain activity as well as impaired behavioral performance of RI in OCRD. Despite the growing evidence suggesting a RI deficit as a fundamental process in OCRD, no validated treatment exists that can directly alter RI deficits and in turn ameliorate OCRD symptoms. It is vital to develop a highly specific intervention that precisely engages a theoretically and empirically well-grounded target such as RI deficits, to significantly improve the efficacy of our intervention efforts. The overarching goal of this study is to examine whether the computerized cognitive training program can improve the neural indicators of the ability to inhibit inappropriate responses, and produce a clinically meaningful level of reduction in obsessive-compulsive disorder and related symptoms. Our central hypothesis is that cognitive training designed to enhance RI will improve neural indices: fronto-basal ganglia circuitry, especially right inferior frontal cortex of RI among individuals with OCRDs. We also hypothesize that the change in the RI neural circuit will mediate the consequent clinical improvements in OCRD symptomatology.
Phase I (R61) will aim to examine change in neural RI indices via the RIT intervention, Adults diagnosed with OCRD problems (OCD, TTM, or SPD) will be randomly assigned to the RIT or placebo control (PLT) condition. At pre- and post-training, neurobehavioral measures of RI will be taken, including the Stop-Signal Task (SST) assessing SSRT and fMRI task assessing rIFC activation. Each RIT participant will continue with the training within the range of 8 to 16 sessions until the criterion-level change in SSRT is attained (based on the ongoing SSRT estimation), with the PLT group receiving comparable levels of training. We will also collect 1-month follow-up data on functional outcomes in order to obtain information on the effect of the intervention on the OCRD symptom indices.
Phase II (R33) is identical to Phase I in the overall study procedures. Adults diagnosed with OCRD problems will be assigned to RIT or PLT. Analytic focus will be on the reduction in OCRD symptoms and their potential mediational pathway (rather than the change in the neural RI indices, which is the primary analytic focus in Phase I). Other than these differences, the overall flow and procedures of the study will be identical between Phases I and II.
The key assessments will include the fMRI tasks of the RI processes and clinician-administered measures of OCRD symptoms. There are other self-reported, computerized, and clinician-administered measures that will be administered across various points over the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of the two training groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Response Inhibition Training (RIT) | Experimental | Behavioral: Computerized cognitive trainingResponse Inhibition Training (RIT) is a about 40-level computer game designed to offer systematic practice of RI. Participants use the computer keyboard and mouse to respond to the demands of trials that are designed to offer training on response inhibition abilities, including suppressing pre-potent but irrelevant stimuli and responses. Each training session will last approximately 45 minutes. All participants will be offered a minimum of 8 sessions. Throughout training, we will continually monitor their behavioral RI index (= stop signal reaction time; SSRT) using a stop-signal task. If a participant's Index SSRT fails to reach a criterion-level reduction (i.e., approximately 1 SD) after the standard 8 session intervention, the RIT intervention will be extended up to 16 sessions until the criterion-level improvement in behavioral RI is attained. |
| Placebo Training (PLT) | Placebo comparator | Behavioral: Computerized placebo trainingThis training condition is designed to serve as an appropriate control condition for RIT, by providing no active ingredient of RI training components, while maintaining the overall training materials and structure similar. Similar to RIT, PLT uses the same task materials and a similar 40-level game structure. However, PLT will present simple RI-irrelevant visual judgment tasks to avoid changing RI-relate processes. The number of 45-min training sessions will be determined by their counterpart RIT participants through a yoked-control design. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age between 18 and 60
- moderate level of OCRD symptoms (Yale-Brown Obsessive Compulsive Scale total ≥ 16, Massachusetts General Hospital-Hair pulling Scale total ≥ 12, or Skin Picking Scale-Revised total ≥ 7)
- a primary diagnosis of OCRD (i.e., OCD, TTM, or SPD)
- estimated IQ > 80
- presence of a RI deficits (SSRT ≥ 215ms).
Key exclusion criteria (8 listed)
- Current substance use disorder
- Severe ADHD
- Lifetime diagnosis of psychotic disorder, bipolar disorder, or schizophrenia
- Current psychotherapy
- Change in psychotropic medication status within 8 weeks before the study or during the study
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 |
|---|---|---|
| Computerized cognitive trainingThis intervention offers 45-minute computerized training sessions to each participant. This intervention aims to improve the individual's RI capabilities. All participants will receive 8 to 16 sessions after being randomized to this condition. | Behavioural | Response Inhibition Training (RIT) |
| Computerized placebo trainingThis intervention offers 45-minute computerized placebo cognitive training sessions to each participant. This intervention aims to exert no focused training on RI capabilities. All participants will receive 8 to 16 sessions after being randomized to this condition. | Behavioural | Placebo Training (PLT) |
Primary outcome
Change in obsessive-compulsive disorder symptom severity over time
Time frame: Week 0, Week 4, Week 8 ~ 12
Depending on participant's primary diagnostic condition, Yale-Brown Obsessive Compulsive Scale (YBOCS) will be used as the primary outcome measure for assessing the change in OCD symptoms over time. The total score ranges between 0 and 40 with higher scores indicating worse outcomes (= more severe symptoms).
Change in compulsive hair pulling symptom severity over time
Time frame: Week 0, Week 4, Week 8 ~ 12
Depending on participant's primary diagnostic condition, National Institute of Mental Health - Trichotillomania Symptom Severity Scale (NIMH-TSS) will be used as the primary outcome measure for assessing the change in hair pulling symptoms over time. The total score ranges between 0 and 25 with higher scores indicating worse outcomes (= more severe symptoms).
Change in compulsive skin picking symptom severity over time
Time frame: Week 0, Week 4, Week 8 ~ 12
Depending on participant's primary diagnostic condition, Yale-Brown Obsessive Compulsive Scale modified for Neurotic Excoriation (NE-YBOCS) will be used as the primary outcome measure for assessing the change in skin picking symptoms over time. The total score ranges between 0 and 40 with higher scores indicating worse outcomes (= more severe symptoms).
Change in activation in the right inferior frontal cortex (rIFC)
Time frame: Week 0, Week 4
Change in the level of blood-oxygen-level-dependent (BOLD) signal activation in the right inferior frontal cortex (rIFC) will be assessed using the stop-signal task (SST) that will be administered while the participant undergoes a functional magnetic resonance imaging procedure.
1 secondary outcome
Change in the Clinical Global Impression Scale
Time frame: Week 0, Week 4, Week 8 ~ 12
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Hanjoo Lee, Ph.D. principal investigator
University of Wisconsin, Milwaukee
Christine Larson, Ph.D. principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive training in people with Obsessive-Compulsive Disorder and Tricholemmoma, run by University of Wisconsin, Milwaukee 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 8 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 10 Aug 2026. 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. Some participants in this study may receive a placebo. 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 Hanjoo Lee, Ph.D. (414-229-5858, leehj@uwm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in obsessive-compulsive disorder symptom severity over time (time frame: Week 0, Week 4, Week 8 ~ 12). The study lists 4 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 10 Aug 2026.