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

November 15, 2012
April 15, 2014
November 2012
August 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01730261 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Online Emotional Regulation Group Treatment
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Traumatic Brain Injury
  • Executive Dysfunction
  • Emotional Dysregulation
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)
Experimental: Online Emotional Regulation Treatment
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
Intervention: Behavioral: Online Emotional Regulation Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2017
August 2017   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Jennifer Oswald 212-241-5152 Jennifer.Oswald@mountsinai.org
United States
 
NCT01730261
GCO 12-1256-3, HSM 12-00760, IF1435434
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Wayne Gordon, PhD Mount Sinai School of Medicine
Mount Sinai School of Medicine
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP