- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03182075
Computerized Training for Individuals Diagnosed With Obsessive-Compulsive and Related Disorders (EmRT)
March 13, 2024 updated by: Carolyn Rodriguez, Stanford University
Emotional Reactivity Training for Obsessive-Compulsive and Related Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Training
OCD and hoarding disorder participants will receive active emotional reactivity training (14 sessions) via computer.
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OCD and hoarding disorder participants will receive 14 sessions of training via computer within 3 weeks.
|
Sham Comparator: Passive Training
OCD and hoarding disorder participants will receive passive computerized training (14 sessions) via computer.
|
OCD and hoarding disorder participants will receive 14 sessions of training via computer within 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale-Brown Obsessive Compulsive Scale (for participants diagnosed with OCD)
Time Frame: up to 2 months
|
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.
|
up to 2 months
|
Savings Inventory Revised Scale (for participants diagnosed with hoarding disorder)
Time Frame: up to 2 months
|
The SI-R is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.
|
up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2018
Primary Completion (Actual)
November 12, 2018
Study Completion (Actual)
November 12, 2018
Study Registration Dates
First Submitted
June 7, 2017
First Submitted That Met QC Criteria
June 7, 2017
First Posted (Actual)
June 9, 2017
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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