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

Primary Purpose

Obsessive Compulsive Disorder, Trichotillomania

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Response inhibition training
Placebo Control Training
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring OCD, Trichotillomania, Response inhibition, Cognitive training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychology Clinic, University of Wisconsin-Milwaukee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Response inhibition training

Placebo Control Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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%.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 7, 2014
Last Updated
August 28, 2018
Sponsor
University of Wisconsin, Milwaukee
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02059980
Brief Title
Developing Effective Response Inhibition Training for Symptom Relief in OCD and Trichotillomania
Official Title
Developing Effective Response Inhibition Training for Symptom Relief in Obsessive-Compulsive and Related Disorders and Trichotillomania
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder, Trichotillomania
Keywords
OCD, Trichotillomania, Response inhibition, Cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Response inhibition training
Arm Type
Experimental
Arm Description
Eight 45-minute sessions of computerized training on response inhibition over a 4 week period
Arm Title
Placebo Control Training
Arm Type
Placebo Comparator
Arm Description
Eight 45-minute sessions of computerized placebo control training over a 4 week period
Intervention Type
Behavioral
Intervention Name(s)
Response inhibition training
Intervention Description
This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control Training
Intervention Description
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 Outcome Measure Information:
Title
Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)
Description
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.
Time Frame
Baseline, Week 4, and Week 8
Title
Stop Signal Reaction Time
Description
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%.
Time Frame
Baseline, Week 4, and Week 8
Secondary Outcome Measure Information:
Title
Clinical Global Impression Severity and Improvement
Description
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.
Time Frame
Baseline, Week 4, and Week 8
Title
Commission Errors on the Go/No-go Task.
Description
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.
Time Frame
Baseline, Week 4, and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Joo Lee, Ph.D.
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychology Clinic, University of Wisconsin-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

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

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