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

Obsessive Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059980
• Other study ID #: R21-RIT_OC-LEE
• Secondary ID: R21MH094537
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2018
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder
• Trichotillomania

Intervention

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 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.

Locations

Country	Name	City	State
United States	Psychology Clinic, University of Wisconsin-Milwaukee	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)	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.	Baseline, Week 4, and Week 8
Primary	Stop Signal Reaction Time	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%.	Baseline, Week 4, and Week 8
Secondary	Clinical Global Impression Severity and Improvement	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.	Baseline, Week 4, and Week 8
Secondary	Commission Errors on the Go/No-go Task.	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.	Baseline, Week 4, and Week 8