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NCT Number: NCT02059980

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

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Obsessive-Compulsive Disorder Trichotillomania

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychology Clinic, University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

  2. 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

  1. Clinical Global Impression Severity and Improvement

    Time frame: Baseline, Week 4, and Week 8

    The Clinical Global Impression Severity and Improvement (CGI) is a clinician-administered rating scale widely used to assess the overall severity of the target condition in treatment outcome research. The CGI is assessed on a 7-point scale, with the severity scale from 1 (Normal, not at all ill) through to 7 (Among the most severely ill patients). Thus, the higher CGI severity rating score indicate a greater level of overall illness.

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

    Time frame: Baseline, Week 4, and Week 8

    The number of commission errors on the go/no-go task is a commonly used measure of response inhibition. In this task, participants are asked to withhold their responses on no-go trials. If they fail to withhold their response in a no-go trial (i.e., pressing the response key to the no-go signal), this response counts toward the total number of commission errors. Therefore, a greater number of commission errors on this task reflects a greater level of inhibitory control deficit.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Milwaukee

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2014
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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