What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacological options like SSRIs and clomipramine, which can cause nausea, headache, insomnia, sexual dysfunction, and weight gain. Cognitive-behavioral therapy (CBT), especially exposure and response prevention (ERP), generally has fewer side effects but may temporarily increase anxiety and distress. Deep brain stimulation (DBS) is an invasive option with risks such as infection, hemorrhage, confusion, and seizures. Response Inhibition Training (RIT), a novel computerized intervention, is being studied for its potential to enhance neural mechanisms of response inhibition with minimal side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, sertraline, and paroxetine, as well as the tricyclic antidepressant clomipramine. These medications help manage symptoms by increasing serotonin levels in the brain. Cognitive-behavioral therapy (CBT), particularly exposure and response prevention (ERP), is also a well-established treatment for OCD. The novel intervention, Response Inhibition Training (RIT), aims to enhance neural mechanisms of response inhibition to improve symptoms of OCD, which is a different approach compared to the pharmacological treatments and CBT.

What other types of research exist?

Promising novel alternatives to Response Inhibition Training for OCD patients include: 1) Deep Brain Stimulation (DBS), which involves implanting electrodes to modulate brain activity and has shown promising results in treatment-refractory cases. 2) Cognitive-Behavioral Therapy (CBT), particularly when combined with DBS, which has been effective in reducing compulsive behaviors. 3) Transcranial Magnetic Stimulation (TMS), an experimental neuromodulation technique that is being explored for severe OCD. These treatments offer potential benefits and are subjects of ongoing research.

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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)

Must not have

Current psychotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 4, week 8 ~ 12

Summary

This trial tests a computer-based training program to help people with OCD, hair-pulling, and skin-picking disorders improve their self-control. The training aims to strengthen brain areas that help stop inappropriate actions, potentially reducing symptoms.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with OCD, TTM, or SPD.

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I have moderate to severe symptoms of OCD, hair-pulling, or skin-picking.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently undergoing psychotherapy.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 4, week 8 ~ 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Change in the Clinical Global Impression Scale

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obsessive-Compulsive Disorder (OCD) include SSRIs, CBT, and emerging therapies like Response Inhibition Training (RIT). SSRIs increase serotonin levels in the brain, helping to alleviate mood and anxiety symptoms. CBT, especially exposure and response prevention (ERP), teaches patients to face their fears and reduce compulsive behaviors by breaking the cycle of avoidance and anxiety. RIT focuses on enhancing neural mechanisms of response inhibition, which is vital for patients who struggle to suppress compulsive actions. Understanding these mechanisms helps patients and healthcare providers select the most effective treatment tailored to individual needs.

Treatment of chronic obsessive-compulsive neurosis by in-vivo exposure. A two-year follow-up and issues in treatment.Combining Drug and Psychological Treatments for Obsessive- Compulsive Disorder: What is the Evidence, When and for Whom.