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Online Emotion Regulation Group Intervention

Primary Purpose

Traumatic Brain Injury, Executive Dysfunction, Emotion Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Emotion Regulation Skills-training
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, TBI, Executive Dysfunction, Emotional Regulation, Emotional Dysfunction, Problem Solving, Self-regulation, Cognitive Rehabilitation, Metacognitive Strategies, Cognitive-behavioral therapy, Online Therapy, GroupTherapy, Group videoconference, Telehealth, Telerehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Intervention

Waitlist Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Positive Affect Negative Affect Schedule (PANAS)
A 20-item measure with two independent scales, positive affect and negative affect.
Satisfaction with Life Scale (SWLS)
A 5-item measure of satisfaction with life globally.
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.
Dysexecutive Functioning Questionnaire (DEX)
A 20-item sensitive and ecologically valid questionnaire assessing everyday problems.
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.
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.
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.

Full Information

First Posted
March 12, 2018
Last Updated
October 4, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT03479606
Brief Title
Online Emotion Regulation Group Intervention
Official Title
A Randomized Controlled Trial of an Online Emotion Regulation Intervention Following TBI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Executive Dysfunction, Emotion Dysfunction, Emotion Dysregulation
Keywords
Traumatic Brain Injury, TBI, Executive Dysfunction, Emotional Regulation, Emotional Dysfunction, Problem Solving, Self-regulation, Cognitive Rehabilitation, Metacognitive Strategies, Cognitive-behavioral therapy, Online Therapy, GroupTherapy, Group videoconference, Telehealth, Telerehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Emotion Regulation Skills-training
Other Intervention Name(s)
Emotion Regulation Training (EmReg)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
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
Secondary Outcome Measure Information:
Title
Positive Affect Negative Affect Schedule (PANAS)
Description
A 20-item measure with two independent scales, positive affect and negative affect.
Time Frame
Every 4 weeks for 28 or 40 weeks
Title
Satisfaction with Life Scale (SWLS)
Description
A 5-item measure of satisfaction with life globally.
Time Frame
Every 4 weeks for 28 or 40 weeks
Title
Problem Solving Inventory (PSI)
Description
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
Title
Dysexecutive Functioning Questionnaire (DEX)
Description
A 20-item sensitive and ecologically valid questionnaire assessing everyday problems.
Time Frame
Every 4 weeks for 28 or 40 weeks
Title
Transition Ratings (TR)
Description
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
Title
Progress Toward Goals (PTG)
Description
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
Title
Skill Acquisition Quiz (SAQ)
Description
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
Other Pre-specified Outcome Measures:
Title
Access to Care Questionnaire (ACQ)
Description
A brief questionnaire to assess participants' access to rehabilitation services using modified items borrowed from national health surveys.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Kajankova, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristen Dams-O'Connor, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Theodore Tsaousides, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Online Emotion Regulation Group Intervention

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