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Behavioral Intervention
Response Inhibition Training for Obsessive-Compulsive Disorder (OCRD Trial)
N/A
Recruiting
Led By Hanjoo Lee, Ph.D.
Research Sponsored by University of Wisconsin, Milwaukee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A primary diagnosis of OCRD (i.e., OCD, TTM, or SPD)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 4, week 8 ~ 12
Awards & highlights
OCRD Trial Summary
This trialwill assess a new computerized intervention to improve response inhibition and reduce symptoms of OCD, trichotillomania, and skin picking disorder.
Who is the study for?
This trial is for adults aged 18-60 with moderate to severe obsessive-compulsive or related disorders (OCRD), such as OCD, trichotillomania, or skin picking disorder. Participants should have certain levels of symptoms measured by specific scales and a deficit in response inhibition. They must not have psychotic disorders, bipolar disorder, schizophrenia, high suicide risk, MRI contraindications, substance use issues, severe ADHD or recent changes in psychotropic meds.Check my eligibility
What is being tested?
The study tests a computerized intervention called Response Inhibition Training (RIT) against placebo training to see if it can improve the brain's ability to stop inappropriate responses in people with OCRD. Participants will undergo multiple sessions and be evaluated through clinical assessments and brain imaging before and after training and at a one-month follow-up.See study design
What are the potential side effects?
Since this trial involves computerized cognitive training rather than medication or invasive procedures, side effects are minimal but may include eye strain from screen time or discomfort during MRI scans.
OCRD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with OCD, TTM, or SPD.
Select...
I have moderate to severe symptoms of OCD, hair-pulling, or skin-picking.
Select...
I am between 18 and 60 years old.
OCRD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0, week 4, week 8 ~ 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 4, week 8 ~ 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in activation in the right inferior frontal cortex (rIFC)
Change in compulsive hair pulling symptom severity over time
Change in compulsive skin picking symptom severity over time
+1 moreSecondary outcome measures
Change in the Clinical Global Impression Scale
OCRD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Response Inhibition Training (RIT)Experimental Treatment1 Intervention
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.
Group II: Placebo Training (PLT)Placebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computerized cognitive training
2016
N/A
~480
Find a Location
Who is running the clinical trial?
University of Wisconsin, MilwaukeeLead Sponsor
49 Previous Clinical Trials
6,515 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
121 Patients Enrolled for Obsessive-Compulsive Disorder
Hanjoo Lee, Ph.D.Principal InvestigatorUniversity of Wisconsin, Milwaukee
1 Previous Clinical Trials
54 Total Patients Enrolled
Christine Larson, Ph.D.Principal InvestigatorUniversity of Wisconsin, Milwaukee
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with OCD, hair-pulling disorder, or skin-picking disorder.I have been diagnosed with OCD, TTM, or SPD.You have an IQ score of at least 80.I have moderate to severe symptoms of OCD, hair-pulling, or skin-picking.I have moderate symptoms of OCD, hair-pulling, or skin-picking.I am between 18 and 60 years old.I am currently undergoing psychotherapy.I haven't changed my mental health medication in the last 8 weeks.I am between 18 and 60 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Training (PLT)
- Group 2: Response Inhibition Training (RIT)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are taking part in this investigation?
"That is accurate. As reflected on clinicaltrials.gov, the trial which was initially posted on November 1st 2022 remains open for new enrolments and has been recently updated as of November 2nd 2022. 118 volunteers need to be signed up from one clinic site."
Answered by AI
Are adults aged 35 and up eligible for this medical trial?
"The qualifications for enrolment in this study are that the person must be between 18 to 60 years of age. There is an additional 23 studies designated for minors and 67 trials open to those over 65."
Answered by AI
Is the study actively seeking participants?
"Records on clinicaltrials.gov demonstrate that this study is still open for enrolment, with the listing having been first published on November 1st 2022 and revised as recently as November 2nd 2022."
Answered by AI
Who is the target demographic for this clinical trial?
"To qualify for this trial, individuals must suffer from OCD and be between 18-60 years old. Currently, 118 patients are being actively recruited to the study."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
UWM Anxiety Disorders Laboratory
Why did patients apply to this trial?
I need help. I’m tired off ruining my eyelashes and eyebrows. I constantly pick my face. I have spoke to doctors about it but they brush it off and kind of shrug.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- UWM Anxiety Disorders Laboratory: < 48 hours
Average response time
- < 2 Days
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