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Online Emotional Regulation Group Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01730261
First received: November 15, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Executive Dysfunction
Emotional Dysregulation
Behavioral: Online Emotional Regulation Treatment
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Difficulties in Emotion Regulation Scale(DERS) [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies


Secondary Outcome Measures:
  • The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ) [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI

  • Problem Solving Inventory [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    35-item self-report questionnaire assessing problem solving capability

  • Social Problem Solving Inventory-Revised: Short Form [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    25-item self-report questionnaire assessing problem solving in everyday living

  • Positive Affect Negative Affect Scale [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    20-item self-report measure of positive and negative affect within a specified time frame

  • Satisfaction with Life Scale [ Time Frame: T1 (baseline) ] [ Designated as safety issue: No ]
    5- item measure of global satisfaction with life

  • Satisfaction with Life Scale [ Time Frame: T2 (week 4) ] [ Designated as safety issue: No ]
    5- item measure of global satisfaction with life

  • Satisfaction with Life Scale [ Time Frame: T3 (week 16) ] [ Designated as safety issue: No ]
    5- item measure of global satisfaction with life

  • Satisfaction with Life Scale [ Time Frame: T4 (week 28) ] [ Designated as safety issue: No ]
    5- item measure of global satisfaction with life

  • Satisfaction with Therapy and Therapist Scale [ Time Frame: T3 (week 16) ] [ Designated as safety issue: No ]
    12-item scale that assesses satisfaction with treatment and therapist

  • Satisfaction with Therapy and Therapist Scale [ Time Frame: T4 (week 28) ] [ Designated as safety issue: No ]
    12-item scale that assesses satisfaction with treatment and therapist

  • Treatment Compliance [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Online Emotional Regulation Treatment
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
Behavioral: Online Emotional Regulation Treatment
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.
Other Name: Emotional Regulation Training (EmReg)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730261

Contacts
Contact: Jennifer Oswald 212-241-5152 Jennifer.Oswald@mountsinai.org

Locations
United States, New York
The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Jason Krellman, PhD       jason.krellman@mountsinai.org   
Contact: Wayne Gordon, PhD    212-659-9372    wayne.gordon@mountsinai.org   
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Wayne Gordon, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01730261     History of Changes
Other Study ID Numbers: GCO 12-1256-3, HSM 12-00760, IF1435434
Study First Received: November 15, 2012
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
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

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014