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Online Emotional Regulation Group Treatment

Primary Purpose

Traumatic Brain Injury, Executive Dysfunction, Emotional Dysregulation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Online Emotional Regulation Treatment
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Online Emotional Regulation Treatment

Arm Description

Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Problem Solving Inventory
35-item self-report questionnaire assessing problem solving capability
Social Problem Solving Inventory-Revised: Short Form
25-item self-report questionnaire assessing problem solving in everyday living
Positive Affect Negative Affect Scale
20-item self-report measure of positive and negative affect within a specified time frame
Satisfaction with Life Scale
5- item measure of global satisfaction with life
Satisfaction with Life Scale
5- item measure of global satisfaction with life
Satisfaction with Life Scale
5- item measure of global satisfaction with life
Satisfaction with Life Scale
5- item measure of global satisfaction with life
Satisfaction with Therapy and Therapist Scale
12-item scale that assesses satisfaction with treatment and therapist
Satisfaction with Therapy and Therapist Scale
12-item scale that assesses satisfaction with treatment and therapist
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

Full Information

First Posted
November 15, 2012
Last Updated
October 1, 2015
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT01730261
Brief Title
Online Emotional Regulation Group Treatment
Official Title
Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Executive Dysfunction, Emotional Dysregulation
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Emotional Regulation Treatment
Arm Type
Experimental
Arm Description
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
Intervention Type
Behavioral
Intervention Name(s)
Online Emotional Regulation Treatment
Other Intervention Name(s)
Emotional Regulation Training (EmReg)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale(DERS)
Description
36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies
Time Frame
up to 28 weeks
Secondary Outcome Measure Information:
Title
The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
Description
32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI
Time Frame
up to 28 weeks
Title
Problem Solving Inventory
Description
35-item self-report questionnaire assessing problem solving capability
Time Frame
up to 28 weeks
Title
Social Problem Solving Inventory-Revised: Short Form
Description
25-item self-report questionnaire assessing problem solving in everyday living
Time Frame
up to 28 weeks
Title
Positive Affect Negative Affect Scale
Description
20-item self-report measure of positive and negative affect within a specified time frame
Time Frame
up to 28 weeks
Title
Satisfaction with Life Scale
Description
5- item measure of global satisfaction with life
Time Frame
T1 (baseline)
Title
Satisfaction with Life Scale
Description
5- item measure of global satisfaction with life
Time Frame
T2 (week 4)
Title
Satisfaction with Life Scale
Description
5- item measure of global satisfaction with life
Time Frame
T3 (week 16)
Title
Satisfaction with Life Scale
Description
5- item measure of global satisfaction with life
Time Frame
T4 (week 28)
Title
Satisfaction with Therapy and Therapist Scale
Description
12-item scale that assesses satisfaction with treatment and therapist
Time Frame
T3 (week 16)
Title
Satisfaction with Therapy and Therapist Scale
Description
12-item scale that assesses satisfaction with treatment and therapist
Time Frame
T4 (week 28)
Title
Treatment Compliance
Description
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
Time Frame
up to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Gordon, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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Online Emotional Regulation Group Treatment

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