Online Emotion Regulation Group Intervention

Traumatic Brain Injury Clinical Trial

Official title:

A Randomized Controlled Trial of an Online Emotion Regulation Intervention Following TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479606
• Other study ID #: GCO 17-0988
• Secondary ID: IRB-17-02795
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Emotion Dysfunction
• Emotion Dysregulation
• Executive Dysfunction
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Access to Care Questionnaire (ACQ)	A brief questionnaire to assess participants' access to rehabilitation services using modified items borrowed from national health surveys.	Baseline
Primary	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.	Every 4 weeks for 28 or 40 weeks
Secondary	Positive Affect Negative Affect Schedule (PANAS)	A 20-item measure with two independent scales, positive affect and negative affect.	Every 4 weeks for 28 or 40 weeks
Secondary	Satisfaction with Life Scale (SWLS)	A 5-item measure of satisfaction with life globally.	Every 4 weeks for 28 or 40 weeks
Secondary	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.	Every 4 weeks for 28 or 40 weeks
Secondary	Dysexecutive Functioning Questionnaire (DEX)	A 20-item sensitive and ecologically valid questionnaire assessing everyday problems.	Every 4 weeks for 28 or 40 weeks
Secondary	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.	End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
Secondary	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.	Every 4 weeks for 28 weeks
Secondary	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.	End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention