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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Wisconsin, Milwaukee
Sponsor:
Information provided by (Responsible Party):
Han Joo Lee, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier:
NCT02059980
First received: February 7, 2014
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Obsessive Compulsive Disorder
Trichotillomania
Behavioral: Response inhibition training
Behavioral: Placebo Control Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing Effective Response Inhibition Training for Symptom Relief in Obsessive-Compulsive and Related Disorders and Trichotillomania

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Milwaukee:

Primary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This is a clinician-administered rating scale of OCD symptom severity, most widely used in treatment outcome research for OCD.

  • National Institute of Mental Health (NIMH) - Trichotillomania Symptom Severity Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This is a clinician-administered rating scale for assessing the severity of hair pulling symptoms, widely used in clinical trial research for trichotillomania.


Secondary Outcome Measures:
  • Clinical Global Impression Severity and Improvement [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This is a clinician-administered rating scale widely used to assess the overall severity and improvement of the target condition in treatment outcome research.


Estimated Enrollment: 40
Study Start Date: August 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Response inhibition training
Eight 45-minute sessions of computerized training on response inhibition over a 4 week period
Behavioral: Response inhibition training
This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance
Placebo Comparator: Placebo Control Training
Eight 45-minute sessions of computerized placebo control training over a 4 week period
Behavioral: Placebo Control Training
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Current depression or other severe anxiety disorders
  • Current psychotherapy
  • Current psychoactive medications
  • Current suicidality
  • Estimated intellectual functioning < 80
  • Lack of response inhibition deficits on a stop-signal task
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059980

Contacts
Contact: Han Joo Lee, Ph.D. 414-229-5858 leehj@uwm.edu

Locations
United States, Wisconsin
Psychology Clinic, University of Wisconsin-Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Han Joo Lee, Ph.D.    414-229-5858    leehj@uwm.edu   
Principal Investigator: Han Joo Lee, Ph.D.         
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Investigators
Principal Investigator: Han Joo Lee, Ph.D. University of Wisconsin, Milwaukee
  More Information

No publications provided

Responsible Party: Han Joo Lee, Assistant Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT02059980     History of Changes
Other Study ID Numbers: R21-RIT_OC-LEE, R21 MH094537
Study First Received: February 7, 2014
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Milwaukee:
OCD
Trichotillomania
Response inhibition
Cognitive training

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Trichotillomania
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Impulse Control Disorders
Personality Disorders

ClinicalTrials.gov processed this record on August 19, 2014