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

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ClinicalTrials.gov Identifier: NCT02059980
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obsessive Compulsive Disorder Trichotillomania Behavioral: Response inhibition training Behavioral: Placebo Control Training

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing Effective Response Inhibition Training for Symptom Relief in Obsessive-Compulsive and Related Disorders and Trichotillomania
Study Start Date : August 2014
Primary Completion Date : August 2017
Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Baseline ]
    This is a clinician-administered rating scale of OCD symptom severity, most widely used in treatment outcome research for OCD.

  2. National Institute of Mental Health (NIMH) - Trichotillomania Symptom Severity Scale [ Time Frame: Baseline ]
    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 :
  1. Clinical Global Impression Severity and Improvement [ Time Frame: Baseline ]
    This is a clinician-administered rating scale widely used to assess the overall severity and improvement of the target condition in treatment outcome research.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
  • Severe depressive symptoms
  • Current psychotherapy
  • Current suicidality
  • Estimated intellectual functioning < 80
  • Lack of response inhibition deficits on a stop-signal task
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059980


Locations
United States, Wisconsin
Psychology Clinic, University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
University of Wisconsin, Milwaukee
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Han Joo Lee, Ph.D. University of Wisconsin, Milwaukee
More Information

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
R21MH094537 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

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

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