An interventional study of Online Emotion Regulation Skills-training in Traumatic Brain Injury, Executive Dysfunction and Emotion Dysfunction, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-06.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Other
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 enrolled and will receive 24, 60-minute emotion regulation skills-training sessions twice a week for 12 weeks, delivered online in a group video-conference with 3-5 other participants. Participants will be asked to complete online surveys, lasting approximately 40-50 minutes, every four weeks during the intervention and the 12-week follow-up phase. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's enrollment of 137 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Participants will receive 24 online emotional regulation skills-training sessions twice weekly and will complete online questionnaires sent every four weeks throughout baseline, the 12-week intervention, and 12-week follow-up.
Behavioral: Online Emotion Regulation Skills-training
After a 12-week wait-period without any intervention, participants will receive 24 online emotion regulation skills-training sessions. Every four weeks, participants will complete online questionnaires every throughout baseline, 12-week wait-period, 12-week intervention, and 12-week follow-up.
Behavioral: Online Emotion Regulation Skills-training
Emotion Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation. The intervention is divided into two phases: knowledge provision and practice facilitation. During the knowledge provision phase participants are introduced to the objectives and the main concepts of the intervention, to increase their familiarity with the terminology, and to the emotion regulation skills they acquire during the practice facilitation phase. During the practice facilitation phase participants receive training in emotion regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
Also known as: Emotion Regulation Training (EmReg)
Difficulties in Emotion Regulation Scale (DERS)
36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies.
Time frame: Every 4 weeks for 28 or 40 weeks
Positive Affect Negative Affect Schedule (PANAS)
A 20-item measure with two independent scales, positive affect and negative affect.
Time frame: Every 4 weeks for 28 or 40 weeks
Satisfaction with Life Scale (SWLS)
A 5-item measure of satisfaction with life globally.
Time frame: Every 4 weeks for 28 or 40 weeks
Problem Solving Inventory (PSI)
A 35-item self-report measure assessing problem solving behavior and attitudes, the PSI yields 3 subscales: Approach/Avoidance Style, Problem Solving Confidence, and Presence of Personal Control.
Time frame: Every 4 weeks for 28 or 40 weeks
Dysexecutive Functioning Questionnaire (DEX)
A 20-item sensitive and ecologically valid questionnaire assessing everyday problems.
Time frame: Every 4 weeks for 28 or 40 weeks
Transition Ratings (TR)
These ratings are used to assess change on problems that are intervention targets, from the participant's point of view, by reporting how much better/worse the problem seems to be since the onset of the intervention.
Time frame: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
Progress Toward Goals (PTG)
During the first 2 sessions, participants will be asked to set three to five personal goals related to emotional regulation and its impact on their daily lives, and then asked to rate their progress towards these goals on a 7-point Likert scale.
Time frame: Every 4 weeks for 28 weeks
Skill Acquisition Quiz (SAQ)
A 20-question content-based quiz developed to assess how well participants learn and retain EmReg concepts and strategies by intervention end.
Time frame: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
Access to Care Questionnaire (ACQ)
A brief questionnaire to assess participants' access to rehabilitation services using modified items borrowed from national health surveys.
Time frame: Baseline
Plan to share: No
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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