Status:
COMPLETED
Online Emotion Regulation Group Intervention
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Traumatic Brain Injury
Executive Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will examine the efficacy of an emotion regulation intervention delivered online to individuals with traumatic brain injury (TBI) with deficits in emotion regulation. 104 subjects will be e...
Detailed Description
This study will assess the efficacy of an emotion regulation skills-training intervention (Online EmReg) provided online to individuals with TBI with emotion regulation difficulties. Specifically, thi...
Eligibility Criteria
Inclusion
- medically documented mild to severe TBI
- at least 6 months post-injury
- deficits in emotional regulation (ER), operationalized as a score of 0.5 standard deviations above published means on the Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004)
- English speaking
- adequate communication skills, assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
- access to and ability to use a device that supports GoToMeeting/Zoom, the videoconference software
- active email address
- access to the Internet with adequate broadband
- Lives in the following states for the duration of the 12-week intervention: New York, California, Maryland, North Carolina, Georgia, Missouri, Arizona, New Jersey, Colorado, Florida, or Washington DC
Exclusion
- current alcohol or substance abuse
- current psychotic disorder, mood disorder with psychotic features or current suicidality, assessed by the Mini International Neuropsychiatric Interview
Key Trial Info
Start Date :
April 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03479606
Start Date
April 5 2018
End Date
September 30 2022
Last Update
October 6 2022
Active Locations (1)
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1
The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029