Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT03479606
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* current alcohol or substance abuse
* current psychotic disorder, mood disorder with psychotic features or current suicidality, assessed by the Mini International Neuropsychiatric Interview
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03479606
Study Brief:
Protocol Section:
NCT03479606