Back to resultsComputerized Training for Individuals Diagnosed With Obsessive-Compulsive and Related Disorders (EmRT)
Primary Purpose
Obsessive Compulsive Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Training
Sponsored by
About this trial
This is an interventional supportive care trial for Obsessive Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, OCD, Obsessive Personality Disorder, Compulsive Behavior, Personality Disorders, Mental Disorders, Anxiety Disorders, Impulsive Behavior, Cognition, Emotion, Emotional Regulation
Eligibility Criteria
Inclusion Criteria:
- age 18 years old and older
- primary diagnosis of OCD
- sufficient severity of OCD symptoms
- Stable on psychotropic or other medication
- capacity to provide informed consent
Exclusion criteria:
- psychiatric or medical conditions that make participation unsafe
- concurrent use of any medications that might increase the risk of participation
- concurrent Cognitive-Behavioral therapy for OCD
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active Training
Passive Training
Arm Description
OCD participants will receive active emotional reactivity training (14 sessions) via computer.
OCD participants will receive passive computerized training (14 sessions) via computer.
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale (for participants diagnosed with OCD)
Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.
Savings Inventory Revised Scale (for participants diagnosed with hoarding disorder)
The SI-R is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03182075
Brief Title
Computerized Training for Individuals Diagnosed With Obsessive-Compulsive and Related Disorders
Acronym
EmRT
Official Title
Emotional Reactivity Training for Obsessive-Compulsive and Related Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to build on our understanding of aberrant emotional processing in OCD. The proposed project tests whether a computerized training aimed to alter emotional processes, can relieve repetitive thoughts and behaviors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, OCD, Obsessive Personality Disorder, Compulsive Behavior, Personality Disorders, Mental Disorders, Anxiety Disorders, Impulsive Behavior, Cognition, Emotion, Emotional Regulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Training
Arm Type
Experimental
Arm Description
OCD participants will receive active emotional reactivity training (14 sessions) via computer.
Arm Title
Passive Training
Arm Type
Sham Comparator
Arm Description
OCD participants will receive passive computerized training (14 sessions) via computer.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Training
Intervention Description
OCD participants will receive 14 sessions of training via computer within 3 weeks.
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (for participants diagnosed with OCD)
Description
Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.
Time Frame
up to 2 months
Title
Savings Inventory Revised Scale (for participants diagnosed with hoarding disorder)
Description
The SI-R is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 years old and older
primary diagnosis of OCD
sufficient severity of OCD symptoms
Stable on psychotropic or other medication
capacity to provide informed consent
Exclusion criteria:
psychiatric or medical conditions that make participation unsafe
concurrent use of any medications that might increase the risk of participation
concurrent Cognitive-Behavioral therapy for OCD
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://rodriguezlab.stanford.edu
Description
Rodriguez Lab Website
Learn more about this trial
Computerized Training for Individuals Diagnosed With Obsessive-Compulsive and Related Disorders
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