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

NCT ID: NCT02059980

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-08-31

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.

Conditions

Obsessive Compulsive Disorder; Trichotillomania

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Response inhibition training

Eight 45-minute sessions of computerized training on response inhibition over a 4 week period

Group Type: EXPERIMENTAL

Response inhibition training

Intervention Type: 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

Eight 45-minute sessions of computerized placebo control training over a 4 week period

Group Type: PLACEBO_COMPARATOR

Placebo Control Training

Intervention Type: 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.

Interventions

Response inhibition training

This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: lead

Responsible Party

Han Joo Lee

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Han Joo Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Milwaukee

Locations

Psychology Clinic, University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21MH094537

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21-RIT_OC-LEE

Identifier Type: -

Identifier Source: org_study_id