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Traumatic Brain InjuryPhase 1NCT01730261

Online Emotional Regulation Group Treatment

A Phase 1 study testing Online Emotional Regulation Treatment 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 feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Online Emotional Regulation Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteUnited States
Study dates
Nov 2012to Oct 2015
Phase
Phase 1
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

  • Documented TBI of any severity and being at least 6 months post injury
  • Presence of executive dysfunction, manifested as self-reported difficulties with emotional and behavioral self-regulation, operationalized as endorsement of 25% or more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz \& Roemer, 2004).
  • Currently aged 18 or older
  • English speaking
  • At least low average intellectual functioning, operationalized as a minimum Verbal IQ score of 80 on the Wechsler Abbreviated Scale of Intelligence
  • Ownership of and relative facility with use of a computer, webcam, and microphone
  • Access to a broadband internet connection at sufficiently high speed to allow videoconference

Who cannot join

  • DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months
  • DSM-IV-TR of psychosis within past 6 months
  • High suicidality, operationalized as a score of 17 or higher on the Mini International Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)
  • Participation in this study will not preclude participation in other treatments.

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: Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)

This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience will also be assessed.

Read the detailed description

This study will examine the feasibility of online delivery of emotional regulation training to individuals with Traumatic Brain Injury who also have emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting software. Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment (24 sessions) and 12 weeks of follow-up. Assessments will be conducted at each of four timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment) and T4 (follow-up assessment). In addition, a subset of the measures will be administered bi-weekly for the duration of the study. Assessments will consist of a variety of measures designed to measure executive functioning, problem solving skills, and quality of life. All assessments will be completed online, using a web-based data collection. Attendance and treatment compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience (including technical difficulties that make access to web-delivered treatment impossible) will also be assessed.

Being tested
Online Emotional Regulation Treatment
Keywords
Traumatic Brain Injury, TBI, Executive Dysfunction, Emotional Regulation, Problem Solving, Self-regulation, Cognitive Rehabilitation, Metacognitive Strategies, Cognitive-behavioral therapy, Online Therapy, Group therapy, 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 Emotional Regulation TreatmentBehavioural

    Also called Emotional Regulation Training (EmReg)

    Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation. EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments. The treatment 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 treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase. During the practice facilitation phase participants receive training in emotional 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 NCT01730261
Study groupRoleWhat they receive
Online Emotional Regulation TreatmentExperimentalParticipants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
Receives: Behavioral: Online Emotional Regulation Treatment

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: up to 28 weeks

Secondary outcomes (11)

  1. The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)

    32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI

    Measured: up to 28 weeks

  2. Problem Solving Inventory

    35-item self-report questionnaire assessing problem solving capability

    Measured: up to 28 weeks

  3. Social Problem Solving Inventory-Revised: Short Form

    25-item self-report questionnaire assessing problem solving in everyday living

    Measured: up to 28 weeks

  4. Positive Affect Negative Affect Scale

    20-item self-report measure of positive and negative affect within a specified time frame

    Measured: up to 28 weeks

  5. Satisfaction with Life Scale

    5- item measure of global satisfaction with life

    Measured: T1 (baseline)

  6. Satisfaction with Life Scale

    5- item measure of global satisfaction with life

    Measured: T2 (week 4)

  7. Satisfaction with Life Scale

    5- item measure of global satisfaction with life

    Measured: T3 (week 16)

  8. Satisfaction with Life Scale

    5- item measure of global satisfaction with life

    Measured: T4 (week 28)

  9. Satisfaction with Therapy and Therapist Scale

    12-item scale that assesses satisfaction with treatment and therapist

    Measured: T3 (week 16)

  10. Satisfaction with Therapy and Therapist Scale

    12-item scale that assesses satisfaction with treatment and therapist

    Measured: T4 (week 28)

  11. Treatment Compliance

    therapist's ratings of participant on each of the following areas at each session: attendance, participation, homework completion, skill acquisition, skill generalization, ease of use of technology, and interpersonal behavior

    Measured: up to 28 weeks

Timeline

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

  1. First posted21 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionOct 2015
  4. Study completionOct 2015

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01730261
Sponsor's protocol ID
GCO 12-1256-3
Other IDs
HSM 12-00760, IF1435434
Status last verified
Oct 2015
First submitted
15 Nov 2012
Last updated
2 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Online Emotional Regulation Treatment 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 7 inclusion and 4 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 2 Oct 2015. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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: up to 28 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 NCT01730261.

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 2 Oct 2015.

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