Clinical trial NCT03479606: Online Emotion Regulation Group Intervention
Official title: A Randomized Controlled Trial of an Online Emotion Regulation Intervention Following TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2018-03-27
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Every 4 weeks for 28 or 40 weeks
Secondary outcomes:
measure: Positive Affect Negative Affect Schedule (PANAS)
timeFrame: Every 4 weeks for 28 or 40 weeks
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Every 4 weeks for 28 or 40 weeks
measure: Problem Solving Inventory (PSI)
timeFrame: Every 4 weeks for 28 or 40 weeks
measure: Dysexecutive Functioning Questionnaire (DEX)
timeFrame: Every 4 weeks for 28 or 40 weeks
measure: Transition Ratings (TR)
timeFrame: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
measure: Progress Toward Goals (PTG)
timeFrame: Every 4 weeks for 28 weeks
measure: Skill Acquisition Quiz (SAQ)
timeFrame: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
Other outcomes:
measure: Access to Care Questionnaire (ACQ)
timeFrame: Baseline
Locations:
city: New York
country: United States
facility: The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Maria Kajankova, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Kristen Dams-O'Connor, PhD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Theodore Tsaousides, PhD
role: PRINCIPAL_INVESTIGATOR
References: