Neural Mechanisms of Response Inhibition Training for OCRD

NCT05377125 | Recruiting DMC

• 1 other identifier: PRO00042324
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder; Tricholemmoma; Skin-Picking

Keywords

OCD; Trichotillomania; Excoriation; Response Inhibition

Outcome Measures

Primary Outcomes (4)

• Change in obsessive-compulsive disorder symptom severity over time

  Depending on participant's primary diagnostic condition, Yale-Brown Obsessive Compulsive Scale (YBOCS) will be used as the primary outcome measure for assessing the change in OCD symptoms over time. The total score ranges between 0 and 40 with higher scores indicating worse outcomes (= more severe symptoms).

  Week 0, Week 4, Week 8 ~ 12

• Change in compulsive hair pulling symptom severity over time

  Depending on participant's primary diagnostic condition, National Institute of Mental Health - Trichotillomania Symptom Severity Scale (NIMH-TSS) will be used as the primary outcome measure for assessing the change in hair pulling symptoms over time. The total score ranges between 0 and 25 with higher scores indicating worse outcomes (= more severe symptoms).

  Week 0, Week 4, Week 8 ~ 12

• Change in compulsive skin picking symptom severity over time

  Depending on participant's primary diagnostic condition, Yale-Brown Obsessive Compulsive Scale modified for Neurotic Excoriation (NE-YBOCS) will be used as the primary outcome measure for assessing the change in skin picking symptoms over time. The total score ranges between 0 and 40 with higher scores indicating worse outcomes (= more severe symptoms).

  Week 0, Week 4, Week 8 ~ 12

• Change in activation in the right inferior frontal cortex (rIFC)

  Change in the level of blood-oxygen-level-dependent (BOLD) signal activation in the right inferior frontal cortex (rIFC) will be assessed using the stop-signal task (SST) that will be administered while the participant undergoes a functional magnetic resonance imaging procedure.

  Week 0, Week 4

Secondary Outcomes (1)

• Change in the Clinical Global Impression Scale

  Week 0, Week 4, Week 8 ~ 12

Study Arms (2)

Response Inhibition Training (RIT)

EXPERIMENTAL

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.

Behavioral: Computerized cognitive training

Placebo Training (PLT)

PLACEBO COMPARATOR

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.

Behavioral: Computerized placebo training

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.

Response Inhibition Training (RIT)

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.

Placebo Training (PLT)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 60
• 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)
• a primary diagnosis of OCRD (i.e., OCD, TTM, or SPD)
• estimated IQ \> 80
• presence of a RI deficits (SSRT ≥ 215ms).

You may not qualify if:

• Current substance use disorder
• Severe ADHD
• Lifetime diagnosis of psychotic disorder, bipolar disorder, or schizophrenia
• Current psychotherapy
• Change in psychotropic medication status within 8 weeks before the study or during the study
• Use of stimulant medication
• Active suicidal risk
• Contraindications for MRI procedures

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead

Study Sites (1)

UWM Anxiety Disorders Laboratory

Milwaukee, Wisconsin, 53211, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Excoriation Disorder; Trichotillomania

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disruptive, Impulse Control, and Conduct Disorders

Study Officials

• Hanjoo Lee, Ph.D.

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

• Christine Larson, Ph.D.

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanjoo Lee, Ph.D.

CONTACT

414-229-5858; leehj@uwm.edu

Christine Larson, Ph.D.

CONTACT

414-229-4996; larsoncl@uwm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed which of the two training conditions they are assigned to. Independent outcome (IE) evaluator will remain blinded to the assigned condition of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of the two training groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 17, 2022
• Study Start: December 22, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)