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Computerized Training for Individuals Diagnosed With Obsessive-Compulsive and Related Disorders (EmRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182075
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Carolyn Rodriguez, Stanford University

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.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Behavioral: Computerized Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Emotional Reactivity Training for Obsessive-Compulsive and Related Disorders
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Training
OCD participants will receive active emotional reactivity training (14 sessions) via computer.
Behavioral: Computerized Training
OCD participants will receive 14 sessions of training via computer within 3 weeks.

Sham Comparator: Passive Training
OCD participants will receive passive computerized training (14 sessions) via computer.
Behavioral: Computerized Training
OCD participants will receive 14 sessions of training via computer within 3 weeks.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182075


Contacts
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Contact: Jordan Wilson 650-723-4095 ocdresearch@stanford.edu
Contact: Maria Filippou-Frye 650-723-4095 ocdresearch@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Jordan Wilson    650-723-4095    ocdresearch@stanford.edu   
Contact: Maria Filippou    650-723-4095    ocdresearch@stanford.edu   
Principal Investigator: Carolyn Rodriguez, MD, PhD         
Sponsors and Collaborators
Stanford University

Additional Information:
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Responsible Party: Carolyn Rodriguez, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03182075    
Other Study ID Numbers: 40185
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolyn Rodriguez, Stanford University:
Obsessive-Compulsive Disorder
Obsessive Personality Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
OCD
Compulsive Behavior
Impulsive Behavior
Cognition
Emotion
Emotional Regulation
Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders