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Traumatic Brain InjuryNCT03479606

Online Emotion Regulation Group Intervention

A study testing Online Emotion Regulation Skills-training in people with Traumatic Brain Injury and Executive Dysfunction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Online Emotion Regulation Skills-training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
1 siteUnited States
Study dates
5 Apr 2018to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • current alcohol or substance abuse
  • current psychotic disorder, mood disorder with psychotic features or current suicidality, assessed by the Mini International Neuropsychiatric Interview

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    New York, New York, 10029

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Online Emotion Regulation Skills-training
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
Medical subject headings
Brain Injuries, Traumatic, Emotional Regulation, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Emotion Regulation Skills-trainingBehavioural

    Also called Emotion Regulation Training (EmReg)

    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.

Study groups in NCT03479606
Study groupRoleWhat they receive
Immediate InterventionExperimentalParticipants 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.
Receives: Behavioral: Online Emotion Regulation Skills-training
Waitlist InterventionActive comparatorAfter 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.
Receives: Behavioral: Online Emotion Regulation Skills-training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every 4 weeks for 28 or 40 weeks

Secondary outcomes (7)

  1. Positive Affect Negative Affect Schedule (PANAS)

    A 20-item measure with two independent scales, positive affect and negative affect.

    Measured: Every 4 weeks for 28 or 40 weeks

  2. Satisfaction with Life Scale (SWLS)

    A 5-item measure of satisfaction with life globally.

    Measured: Every 4 weeks for 28 or 40 weeks

  3. 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.

    Measured: Every 4 weeks for 28 or 40 weeks

  4. Dysexecutive Functioning Questionnaire (DEX)

    A 20-item sensitive and ecologically valid questionnaire assessing everyday problems.

    Measured: Every 4 weeks for 28 or 40 weeks

  5. 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.

    Measured: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention

  6. 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.

    Measured: Every 4 weeks for 28 weeks

  7. 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.

    Measured: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2018
  2. Study start5 Apr 2018
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03479606
Sponsor's protocol ID
GCO 17-0988
Other IDs
IRB-17-02795
Status last verified
Oct 2022
First submitted
12 Mar 2018
Last updated
6 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Online Emotion Regulation Skills-training in people with Traumatic Brain Injury and Executive Dysfunction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difficulties in Emotion Regulation Scale (DERS) (time frame: Every 4 weeks for 28 or 40 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03479606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.

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Online Emotion Regulation Group Intervention | AzTrials