Online Emotion Regulation Group Intervention

Description

This study will examine the efficacy of online delivery of emotional regulation skills training to individuals with Traumatic Brain Injury (TBI) with deficits in emotion regulation. 104 subjects will be enrolled and will receive 24, 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality. Participants will be asked to complete an online survey, lasting approximately 40-50 minutes, every four weeks during the treatment and 12-week follow-up phase. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.

Study Start Date

March, 31 2018

Estimated Completion Date

August 2023

Interventions

  • Behavioral: Online Emotional Regulation Treatment

Study ID

Icahn School of Medicine at Mount Sinai -- IRB-17-02795

Status

Recruiting

Trial ID

NCT03479606

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

104

Sponsor

Icahn School of Medicine at Mount Sinai

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles Maria Kajankova PhD 212-241-3379 maria.kajankova@mountsinai.org

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