Developing Effective Response Inhibition Training for Symptom Relief in OCD and Trichotillomania

NCT02059980 | Completed Results

• 2 other identifiers: R21-RIT_OC-LEER21MH094537
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Obsessive-compulsive disorder (OCD) and its related disorders (e.g., trichotillomania) are characterized by the marked difficulty in inhibiting unwanted or inappropriate responses. There is compelling evidence that poor response inhibition is a core cognitive feature of OCD and its related disorders, but no effective intervention exists that directly attempts to address this problematic cognitive deficiency. This study will examine the feasibility and clinical utility of a computerized cognitive training program designed to improve response inhibition among individuals diagnosed with OCD or trichotillomania.This training program offers systematic practice of response inhibition in the form of a 40-level computer game. Individuals with these conditions will be randomized to either 8 sessions of (a) computerized response inhibition training (RIT) or (b) placebo computer training (PLT). We hypothesize that RIT will outperform PLT in improving response inhibition capabilities and reducing relevant clinical symptoms. In sum, this project is expected to generate important knowledge to guide the development of effective computer-based treatment approaches that may help reduce critical problems of existing treatments such as suboptimal patient retention and treatment under-utilization, thereby improving overall treatment response rates among individuals suffering from OCD and related conditions.

Conditions

Obsessive Compulsive Disorder; Trichotillomania

Keywords

OCD; Trichotillomania; Response inhibition; Cognitive training

Outcome Measures

Primary Outcomes (2)

• Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)

  This is a clinician-administered rating scale of OCD symptom severity, most widely used in treatment outcome research for OCD, and a clinician-administered rating scale of hair pulling symptoms, widely used in clinical trial research for trichotillomania. Given the inclusion of two different diagnostic conditions, the primary outcome for the current study is the z score of the symptom rating severity obtained from the two rating scales, with higher values indicating greater symptom severity.

  Baseline, Week 4, and Week 8

• Stop Signal Reaction Time

  Stop Signal Reaction Time (SSRT; time taken to complete the inhibitory process) is estimated using the tracking algorithm on the computerized stop-signal task, which adjusts the stop signal delay automatically (by 50ms) to maintain the rate of successful inhibition on stop-signal trials at 50%.

  Baseline, Week 4, and Week 8

Secondary Outcomes (2)

• Clinical Global Impression Severity and Improvement

  Baseline, Week 4, and Week 8

• Commission Errors on the Go/No-go Task.

  Baseline, Week 4, and Week 8

Study Arms (2)

Response inhibition training

EXPERIMENTAL

Eight 45-minute sessions of computerized training on response inhibition over a 4 week period

Behavioral: Response inhibition training

Placebo Control Training

PLACEBO COMPARATOR

Eight 45-minute sessions of computerized placebo control training over a 4 week period

Behavioral: Placebo Control Training

Interventions

Response inhibition training BEHAVIORAL

This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance

Response inhibition training

Placebo Control Training BEHAVIORAL

This placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities.

Placebo Control Training

Eligibility Criteria

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

You may qualify if:

• Principal diagnosis of obsessive-compulsive disorder or trichotillomania

You may not qualify if:

• Current substance use problems
• Current/Past Psychotic disorder, bipolar disorder, or schizophrenia
• Attention deficit/hyperactivity disorder or tic disorder
• Severe depressive symptoms
• Current psychotherapy
• Current suicidality
• Estimated intellectual functioning \< 80
• Lack of response inhibition deficits on a stop-signal task

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Psychology Clinic, University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Trichotillomania

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Results Point of Contact

• Title: Dr. Han Joo Lee
• Organization: University of Wisconsin-Milwaukee

leehj@uwm.edu

414-229-5858

Study Officials

• Han Joo Lee, Ph.D.

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-08

Locations

US (1)