Response Inhibition Training for Obsessive-Compulsive Disorder
(OCRD Trial)
Recruiting in Palo Alto (17 mi)
Overseen byHanjoo Lee, Ph.D.
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Wisconsin, Milwaukee
Must not be taking: Stimulants, Psychotropics
Disqualifiers: Substance use, Severe ADHD, Psychotic, others
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.
12345Is 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.
678910How 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.
124511Eligibility 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
+2 more
Exclusion Criteria
Current substance use disorder
Active suicidal risk
Use of stimulant medication
+5 more
Trial 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)
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UWM Anxiety Disorders LaboratoryMilwaukee, WI
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Who Is Running the Clinical Trial?
University of Wisconsin, MilwaukeeLead Sponsor
References
[Can the efficacy of behavioral and cognitive therapy for obsessive compulsive disorder be augmented by innovative computerized adjuvant?] [2018]Cognitive behavioral therapy (CBT) is recognized as an effective treatment for obsessive-compulsive disorder (OCD). To maximize its effectiveness, we designed an "experimental" CBT defined by the addition of a computerized psychoeducative tool.
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]Cognitive behavioral therapy (CBT) including exposure and response prevention (ERP) is the most effective and first-line treatment for obsessive-compulsive disorder (OCD). However, a significant number of people leave it or do not respond to it effectively. The present study aimed to examine the efficacy of personalized-computerized inhibitory training (P-CIT) program combined with ERP on treatment outcomes in patients with contamination OCD.
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]Exposure and response prevention (ERP) remains the most empirically supported psychological treatment for obsessive compulsive disorder (OCD). Clinical guidelines recommend the addition of cognitive approaches to ERP although the presumed additive benefits have not been directly tested. The aim of this was to compare a treatment that integrated cognitive therapy with ERP (ERP + CT) to traditional, manualized ERP to test the additive benefits.
Unguided Computer-Assisted Self-Help Interventions Without Human Contact in Patients With Obsessive-Compulsive Disorder: Systematic Review and Meta-analysis. [2022]Computer-assisted treatment may reduce therapist contact and costs and promote client participation. This meta-analysis examined the efficacy and acceptability of an unguided computer-assisted therapy in patients with obsessive-compulsive disorder (OCD) compared with a waiting list or attention placebo.
Correction of inflated responsibility in the treatment of obsessive-compulsive disorder. [2019]This study evaluates the efficacy of a cognitive treatment for obsessive-compulsive disorder (OCD). Four patients with OCD whose major complaints were checking rituals were treated in a multiple baseline across subjects design. Cognitive correction targeted inflated responsibility, without any exposure or response prevention. All subjects reported a clinically significant decrease in interference caused by rituals, a 52-100% reduction in Y-BOCS scores, and a decrease in perceived responsibility. Therapeutic gains were maintained at follow-up (6 and 12 months) for three patients. Results suggest that cognitive therapy targeting inflated responsibility is a promising alternative to exposure-based treatment.
Effectiveness of Response Inhibition Training and Its Long-Term Effects in Healthy Adults: A Systematic Review and Meta-Analysis. [2022]This study aims to evaluate the effectiveness and long-term effects of response inhibition training as a therapeutic approach in healthy adults.
Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. [2022]People with depression often present with concurrent cognitive impairment. Computerized cognitive training (CCT) is a safe and efficacious strategy to maintain or enhance cognitive performance in a range of clinical populations. However, its efficacy in people with depression and how it varies across populations and design factors are currently unclear.
Effect of Cognitive Training Programs Based on Computer Systems on Executive Functions in Children With ADHD: A Systematic Review. [2023]The purpose of this systematic review is to synthesize the existing literature reporting the effects of computerized cognitive trainings on the executive functions of children with ADHD.
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]This study evaluates the efficacy at 12 months of a computer-based cognitive training (CBCT) program, adjunctive to traditional cognitive training (TCT), on the basis of pen-and-paper exercises.
Computer-based cognitive training for ADHD: a review of current evidence. [2018]There has been an increasing interest in and the use of computer-based cognitive training as a treatment of attention-deficit/hyperactivity disorder (ADHD). The authors' review of current evidence, based partly on a stringent meta-analysis of 6 randomized controlled trials (RCTs) published in 2013, and an overview of 8 recently published RCTs highlights the inconsistency of findings between trials and across blinded and nonblinded ADHD measures within trials. Based on this, they conclude that more evidence from well-blinded studies is required before cognitive training can be supported as a frontline treatment of core ADHD symptoms.
Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. [2018]Behaviour therapy with exposure and response prevention (ERP) or cognitive behavioural therapy (CBT) including ERP are considered the psychological treatments of choice for obsessive-compulsive disorder (OCD), but group CBT/ERP has received relatively little research attention in the treatment of OCD. The aim of this study was to provide a meta-analysis of the effectiveness of group CBT/ERP for OCD.