Neural Mechanisms of Response Inhibition Training for OCRD

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
University of Wisconsin, Milwaukee
Study ID
NCT05377125
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder
  • Skin-Picking
  • Tricholemmoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Computerized cognitive training — BEHAVIORAL
    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 training — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Dec 22, 2022
Status verified
Jul 2024
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Response Inhibition Training (RIT)
    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.
  • Placebo Comparator: Placebo Training (PLT)
    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.

Primary Outcome Measure

Change in obsessive-compulsive disorder symptom severity over time [ Time Frame: Week 0, Week 4, Week 8 ~ 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UWM Anxiety Disorders LaboratoryMilwaukeeWisconsin53211
Halle Berres, B.A.
[email protected]
262-364-6249
Hanjoo Lee, Ph.D.
[email protected]
414-229-5858
Hanjoo Lee, Ph.D.
Christine Larson, Ph.D.

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