Response Inhibition Training for Obsessive-Compulsive Disorder

(OCRD Trial)

Overseen By Hanjoo Lee, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Milwaukee

Must not be taking: Stimulants, Psychotropics

Disqualifiers: Substance use, Severe ADHD, Psychotic, others

Compensation: Varies

Number of Visits: 17

118 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you do not change your psychotropic medication status within 8 weeks before or during the study. If you are on stimulant medication, you may need to stop taking it to participate.

What data supports the effectiveness of the treatment Response Inhibition Training for Obsessive-Compulsive Disorder?

Research suggests that combining computerized cognitive training with traditional therapy methods like exposure and response prevention (ERP) can improve treatment outcomes for obsessive-compulsive disorder (OCD). Additionally, computer-assisted therapy has been shown to be effective and can reduce the need for therapist contact, making it a promising option for OCD treatment. ^{1 2 3 4 5}

Is response inhibition training safe for humans?

Computerized cognitive training, which includes response inhibition training, is considered safe for various conditions, including depression and ADHD, according to existing research. ^{6 7 8 9 10}

How is Response Inhibition Training different from other treatments for OCD?

Response Inhibition Training is unique because it uses computerized cognitive exercises to help improve self-control and reduce compulsive behaviors, offering a potentially more accessible and cost-effective option compared to traditional therapy that requires regular therapist contact. ^{1 2 4 5 11}

Research Team

Hanjoo Lee, Ph.D.

Principal Investigator

University of Wisconsin, Milwaukee

Christine Larson, Ph.D.

Principal Investigator

University of Wisconsin, Milwaukee

Eligibility Criteria

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.

Inclusion Criteria

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

Presence of a RI deficits (SSRT ≥ 215ms)

Estimated IQ > 80

Exclusion Criteria

Current substance use disorder

Active suicidal risk

Use of stimulant medication

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase I

Participants undergo 8 to 16 sessions of computerized Response Inhibition Training (RIT) or placebo training, with neurobehavioral measures taken pre- and post-training.

8-12 weeks

8 to 16 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collected on functional outcomes.

4 weeks

1 visit (in-person or virtual)

Treatment Phase II

Similar to Phase I, participants undergo additional sessions of RIT or placebo training, focusing on reduction in OCRD symptoms.

8-12 weeks

8 to 16 sessions (in-person or virtual)

Treatment Details

Interventions

• Computerized cognitive training
• Computerized placebo training

Trial Overview 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.

Participant Groups

Group I: Response Inhibition Training (RIT) Experimental Treatment 1 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 Group 1 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.

Who Is Running the Clinical Trial?

University of Wisconsin, Milwaukee

Lead Sponsor

Trials

52

Recruited

6,200+

Findings from Research

A randomized trial with 35 patients showed that both standard cognitive behavioral therapy (CBT) and an experimental CBT with a computerized psychoeducative tool led to significant improvements in obsessive-compulsive disorder (OCD) symptoms, with similar reductions in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores (48% vs 45%).

While the computerized tool was well-received by patients and therapists, it did not enhance the overall effectiveness of CBT, indicating that while it may be a useful addition, it does not replace the core therapeutic benefits of standard CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can the efficacy of behavioral and cognitive therapy for obsessive compulsive disorder be augmented by innovative computerized adjuvant?] Morgiève, M., N'Diaye, K., Clair, AH., et al.[2018]

A study involving 30 patients with contamination OCD found that combining personalized-computerized inhibitory training (P-CIT) with exposure and response prevention (ERP) significantly reduced symptom severity and anxiety levels.

The intervention also improved overall quality of life and mental health, suggesting that P-CIT enhances the effectiveness of ERP by improving task control and inhibiting compulsive behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Personalized-Computerized Inhibitory Training program (PCIT) combined with exposure and response prevention on treatment outcomes in patients with contamination obsessive-compulsive disorder. Dehkordi, FJ., Farani, AR., Gharraee, B., et al.[2023]

A study involving 127 participants with OCD found that integrating cognitive therapy with exposure and response prevention (ERP) significantly improved treatment outcomes compared to ERP alone, leading to greater reductions in symptoms and obsessive beliefs.

More patients in the ERP + cognitive therapy group were classified as treatment responders, indicating that combining these approaches can enhance the effectiveness of OCD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the addition of cognitive therapy to exposure and response prevention for obsessive compulsive disorder enhance clinical efficacy? A randomized controlled trial in a community setting. Rector, NA., Richter, MA., Katz, D., et al.[2022]

Unguided computer-assisted self-help therapy for obsessive-compulsive disorder (OCD) was found to be significantly more effective than waiting lists or psychological placebo, with a standardized mean difference of -0.47 based on 11 trials involving 983 participants.

However, this therapy had a higher dropout rate compared to the waiting list or placebo, indicating that while it is effective, it may not be as well accepted by all users, and the overall quality of evidence was low due to high risk of bias in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unguided Computer-Assisted Self-Help Interventions Without Human Contact in Patients With Obsessive-Compulsive Disorder: Systematic Review and Meta-analysis. Imai, H., Tajika, A., Narita, H., et al.[2022]

A cognitive treatment targeting inflated responsibility in four patients with obsessive-compulsive disorder (OCD) led to a significant reduction in ritual interference, with Y-BOCS scores decreasing by 52-100%.

Therapeutic benefits were maintained for three patients at follow-ups conducted 6 and 12 months after treatment, indicating that this cognitive approach could be a viable alternative to traditional exposure-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction of inflated responsibility in the treatment of obsessive-compulsive disorder. Ladouceur, R., Léger, E., Rhéaume, J., et al.[2019]

Response inhibition training significantly improves cognitive function in healthy adults, with a strong effect observed particularly with Go/No-Go (GNG) training and the combination of GNG and Stop-Signal Task (SST) training, based on a meta-analysis of 10 trials involving 490 participants.

While the immediate benefits of response inhibition training are clear, its long-term effects on cognitive function are less significant, although the combination of GNG and SST training does show some lasting improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Response Inhibition Training and Its Long-Term Effects in Healthy Adults: A Systematic Review and Meta-Analysis. Li, W., Shang, Y., Zhuang, W., et al.[2022]

This study aims to systematically review and analyze the efficacy of computerized cognitive training (CCT) in improving cognitive performance in adults with depression, focusing on randomized controlled trials.

The research will explore how CCT affects not only cognitive outcomes but also mood and daily functioning, making it the first comprehensive analysis of its kind in this specific clinical population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. Lampit, A., Launder, NH., Minkov, R., et al.[2022]

Computerized cognitive training programs have shown some positive effects on executive functions like working memory and attention in children with ADHD, based on a systematic review of 20 studies.

However, the results are inconsistent, with significant variability in training methods and measurement tools used, leading to high risks of bias and mixed outcomes across the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Cognitive Training Programs Based on Computer Systems on Executive Functions in Children With ADHD: A Systematic Review. Robledo-Castro, C., Lerma-Castaño, PR., Bonilla-Santos, G.[2023]

A study involving 60 patients with mild cognitive impairment and mild Alzheimer's disease found that adding a computer-based cognitive training (CBCT) program to traditional cognitive training (TCT) significantly reduced anxiety symptoms and improved decision-making after 12 months.

While the CBCT + TCT group showed benefits in anxiety and decision-making, there were no significant changes in basic cognitive functions, suggesting that patients already receiving TCT may have reached a performance ceiling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an adjunctive computer-based cognitive training program in amnestic mild cognitive impairment and Alzheimer's disease: a single-blind, randomized clinical trial. Gaitán, A., Garolera, M., Cerulla, N., et al.[2022]

A review of 14 randomized controlled trials (6 from 2013 and 8 recent studies) on computer-based cognitive training for ADHD shows inconsistent results, indicating that the effectiveness of this treatment is not yet clear.

The authors emphasize the need for more well-blinded studies to determine if cognitive training can be considered a primary treatment option for ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training for ADHD: a review of current evidence. Sonuga-Barke, E., Brandeis, D., Holtmann, M., et al.[2018]

A meta-analysis of 13 trials showed that group cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is an effective treatment for obsessive-compulsive disorder (OCD), with a strong pre-post effect size of 1.18.

Group CBT/ERP outperformed waiting list controls and achieved better results than pharmacological treatments in some studies, indicating its efficacy as a psychological intervention for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. Jónsson, H., Hougaard, E.[2018]

References

1. France pubmed.ncbi.nlm.nih.gov

[Can the efficacy of behavioral and cognitive therapy for obsessive compulsive disorder be augmented by innovative computerized adjuvant?] [2018]

2. India pubmed.ncbi.nlm.nih.gov

Efficacy of Personalized-Computerized Inhibitory Training program (PCIT) combined with exposure and response prevention on treatment outcomes in patients with contamination obsessive-compulsive disorder. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Does the addition of cognitive therapy to exposure and response prevention for obsessive compulsive disorder enhance clinical efficacy? A randomized controlled trial in a community setting. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Unguided Computer-Assisted Self-Help Interventions Without Human Contact in Patients With Obsessive-Compulsive Disorder: Systematic Review and Meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Correction of inflated responsibility in the treatment of obsessive-compulsive disorder. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Response Inhibition Training and Its Long-Term Effects in Healthy Adults: A Systematic Review and Meta-Analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Cognitive Training Programs Based on Computer Systems on Executive Functions in Children With ADHD: A Systematic Review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of an adjunctive computer-based cognitive training program in amnestic mild cognitive impairment and Alzheimer's disease: a single-blind, randomized clinical trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training for ADHD: a review of current evidence. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. [2018]