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Clinical Trials/NCT02059980
NCT02059980
Completed
Not Applicable

Developing Effective Response Inhibition Training for Symptom Relief in Obsessive-Compulsive and Related Disorders and Trichotillomania

University of Wisconsin, Milwaukee1 site in 1 country45 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive Compulsive Disorder
Sponsor
University of Wisconsin, Milwaukee
Enrollment
45
Locations
1
Primary Endpoint
Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
August 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Han Joo Lee

Assistant Professor

University of Wisconsin, Milwaukee

Eligibility Criteria

Inclusion Criteria

  • Principal diagnosis of obsessive-compulsive disorder or trichotillomania

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: Baseline, Week 4, and Week 8

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.

Stop Signal Reaction Time

Time Frame: Baseline, Week 4, and Week 8

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%.

Secondary Outcomes

  • Commission Errors on the Go/No-go Task.(Baseline, Week 4, and Week 8)
  • Clinical Global Impression Severity and Improvement(Baseline, Week 4, and Week 8)

Study Sites (1)

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