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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
147
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.
The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
New York, New York, United States
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
Time frame: up to 28 weeks
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
Time frame: up to 28 weeks
Problem Solving Inventory
35-item self-report questionnaire assessing problem solving capability
Time frame: up to 28 weeks
Social Problem Solving Inventory-Revised: Short Form
25-item self-report questionnaire assessing problem solving in everyday living
Time frame: up to 28 weeks
Positive Affect Negative Affect Scale
20-item self-report measure of positive and negative affect within a specified time frame
Time frame: up to 28 weeks
Satisfaction with Life Scale
5- item measure of global satisfaction with life
Time frame: T1 (baseline)
Satisfaction with Life Scale
5- item measure of global satisfaction with life
Time frame: T2 (week 4)
Satisfaction with Life Scale
5- item measure of global satisfaction with life
Time frame: T3 (week 16)
Satisfaction with Life Scale
5- item measure of global satisfaction with life
Time frame: T4 (week 28)
Satisfaction with Therapy and Therapist Scale
12-item scale that assesses satisfaction with treatment and therapist
Time frame: T3 (week 16)
Satisfaction with Therapy and Therapist Scale
12-item scale that assesses satisfaction with treatment and therapist
Time frame: T4 (week 28)
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
Time frame: up to 28 weeks
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