- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03479606
Online Emotion Regulation Group Intervention
A Randomized Controlled Trial of an Online Emotion Regulation Intervention Following TBI
Study Overview
Status
Intervention / Treatment
Detailed 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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention
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.
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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.
Other Names:
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Active Comparator: Waitlist Intervention
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Every 4 weeks for 28 or 40 weeks
|
36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies.
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Every 4 weeks for 28 or 40 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Affect Negative Affect Schedule (PANAS)
Time Frame: Every 4 weeks for 28 or 40 weeks
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A 20-item measure with two independent scales, positive affect and negative affect.
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Every 4 weeks for 28 or 40 weeks
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Satisfaction with Life Scale (SWLS)
Time Frame: Every 4 weeks for 28 or 40 weeks
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A 5-item measure of satisfaction with life globally.
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Every 4 weeks for 28 or 40 weeks
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Problem Solving Inventory (PSI)
Time Frame: Every 4 weeks for 28 or 40 weeks
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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.
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Every 4 weeks for 28 or 40 weeks
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Dysexecutive Functioning Questionnaire (DEX)
Time Frame: Every 4 weeks for 28 or 40 weeks
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A 20-item sensitive and ecologically valid questionnaire assessing everyday problems.
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Every 4 weeks for 28 or 40 weeks
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Transition Ratings (TR)
Time Frame: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
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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.
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End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
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Progress Toward Goals (PTG)
Time Frame: Every 4 weeks for 28 weeks
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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.
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Every 4 weeks for 28 weeks
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Skill Acquisition Quiz (SAQ)
Time Frame: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
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A 20-question content-based quiz developed to assess how well participants learn and retain EmReg concepts and strategies by intervention end.
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End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Access to Care Questionnaire (ACQ)
Time Frame: Baseline
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A brief questionnaire to assess participants' access to rehabilitation services using modified items borrowed from national health surveys.
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Baseline
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Collaborators and Investigators
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 17-0988
- IRB-17-02795 (Other Identifier: Icahn School of Medicine at Mount Sinai)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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