Online Emotion Regulation Group Intervention

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, this study seeks to accomplish three aims: 1) Evaluate the efficacy of the
Online EmReg intervention immediately post-intervention and at a 12-week follow-up
assessment; 2) Identify factors that optimize the effectiveness of the Online EmReg
intervention; 3) Explore the impact of Online EmReg on positive and negative affect, life
satisfaction, and executive functioning. The study design is a randomized control trial with
a waitlist control group whereby the participants in the control group undergo the training
after a 12 week waiting period. 104 subjects with TBI and self-reported deficits in emotion
regulation will be enrolled.

The intervention protocol calls for 24, 60-minute emotion regulation sessions twice a week
for 12 weeks, delivered online via GoToMeeting by post-doctoral level therapists with
specialty training in rehabilitation neuropsychology. Study participation will last
approximately 28 weeks for participants in the immediate intervention arm (4 weeks
preparation, 12 weeks intervention, 12 weeks follow-up) and 40 weeks for participants in the
waitlist arm (4 weeks preparation, 12 weeks waitlist, 12 weeks intervention, and 12 weeks
follow-up). Core assessments will be conducted at each major time point: T1 (baseline), T2
(immediate intervention end/waitlist baseline), T3 (immediate intervention follow-up/end of
waitlist intervention), and T4 (waitlist follow-up). A subset of the measures will be
administered every 4 weeks between each major time point for the duration of the study.

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, the videoconference
software

- active email address

- access to the Internet with adequate broadband

- Lives in New York State for duration of study

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