Online Emotion Regulation Group Intervention
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Emotion Dysfunction
- Emotion Dysregulation
- Executive Dysfunction
- Traumatic Brain Injury
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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, this study seeks to accomplish three aims: 1) Evaluate the efficacy of the Online EmReg intervention im...
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 Zoom 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.
Tracking Information
- NCT #
- NCT03479606
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Investigators
- Principal Investigator: Maria Kajankova, PhD Icahn School of Medicine at Mount Sinai Study Director: Kristen Dams-O'Connor, PhD Icahn School of Medicine at Mount Sinai Principal Investigator: Theodore Tsaousides, PhD Icahn School of Medicine at Mount Sinai
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