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

• ClinicalTrials.gov Identifier: NCT02059980
• Recruitment Status: Completed
• First Posted: February 11, 2014
• Results First Posted: September 26, 2018
• Last Update Posted: September 26, 2018
• Sponsor: University of Wisconsin, Milwaukee
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Han Joo Lee, University of Wisconsin, Milwaukee

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	Phase
Obsessive Compulsive Disorder; Trichotillomania	Behavioral: Response inhibition training; Behavioral: Placebo Control Training	Not Applicable

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
• Actual Primary Completion Date: August 2017
• Actual Study Completion Date: August 2017

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. 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 Outcome Measures :

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.

Eligibility Criteria

• 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

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

  Study Documents (Full-Text)

Documents provided by Han Joo Lee, University of Wisconsin, Milwaukee:

Study Protocol and Statistical Analysis Plan  [PDF] July 1, 2018

More Information

• Responsible Party: Han Joo Lee, Assistant Professor, University of Wisconsin, Milwaukee
• ClinicalTrials.gov Identifier: NCT02059980
• Other Study ID Numbers: R21-RIT_OC-LEE; R21MH094537 ( U.S. NIH Grant/Contract )
• First Posted: February 11, 2014
• Results First Posted: September 26, 2018
• Last Update Posted: September 26, 2018
• Last Verified: August 2018

Keywords provided by Han Joo Lee, University of Wisconsin, Milwaukee:

OCD; Trichotillomania; Response inhibition; Cognitive training

Additional relevant MeSH terms:

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