Back to resultsPersonalized Computerized Inhibitory Control Training for OCD
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Computer Program
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Cognitive Behavioral Therapy
Eligibility Criteria
Inclusion Criteria:
- Principal diagnosis of OCD (assessed by SCID).
- Clinically significant OCD symptoms (Y-BOCS score of at least 16).
- Have a history of completing a trial of at least 1 EX/RP sessions.
- Have access to a computer or laptop.
Exclusion Criteria:
- Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
- Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
- Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
- Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
- Active suicidality warranting immediate clinical care.
Sites / Locations
- New York State Psychiactic Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT + Personalized Computer Program
Arm Description
Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program
Outcomes
Primary Outcome Measures
Obsessive-compulsive symptoms measured after 3 weeks of treatment
measured by Yale Brown Obsessive Compulsive Scale (YBOCS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02378896
First Posted
February 27, 2015
Last Updated
January 25, 2018
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT02378896
Brief Title
Personalized Computerized Inhibitory Control Training for OCD
Official Title
Personalized Computerized Inhibitory Control Training for OCD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.
Detailed Description
This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Cognitive Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT + Personalized Computer Program
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program
Intervention Type
Behavioral
Intervention Name(s)
Personalized Computer Program
Intervention Description
Training with a personalized computerized inhibitory training program
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy
Primary Outcome Measure Information:
Title
Obsessive-compulsive symptoms measured after 3 weeks of treatment
Description
measured by Yale Brown Obsessive Compulsive Scale (YBOCS)
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Principal diagnosis of OCD (assessed by SCID).
Clinically significant OCD symptoms (Y-BOCS score of at least 16).
Have a history of completing a trial of at least 1 EX/RP sessions.
Have access to a computer or laptop.
Exclusion Criteria:
Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
Active suicidality warranting immediate clinical care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen B Simpson, M.D., PhD
Organizational Affiliation
New York State Psychiactic Institute, Anxiety Disorders Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiactic Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
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Personalized Computerized Inhibitory Control Training for OCD
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