Clinical trial NCT01730261: Online Emotional Regulation Group Treatment
Official title: Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale(DERS)
timeFrame: up to 28 weeks
Secondary outcomes:
measure: The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
timeFrame: up to 28 weeks
measure: Problem Solving Inventory
timeFrame: up to 28 weeks
measure: Social Problem Solving Inventory-Revised: Short Form
timeFrame: up to 28 weeks
measure: Positive Affect Negative Affect Scale
timeFrame: up to 28 weeks
measure: Satisfaction with Life Scale
timeFrame: T1 (baseline)
measure: Satisfaction with Life Scale
timeFrame: T2 (week 4)
measure: Satisfaction with Life Scale
timeFrame: T3 (week 16)
measure: Satisfaction with Life Scale
timeFrame: T4 (week 28)
measure: Satisfaction with Therapy and Therapist Scale
timeFrame: T3 (week 16)
measure: Satisfaction with Therapy and Therapist Scale
timeFrame: T4 (week 28)
measure: Treatment Compliance
timeFrame: up to 28 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Wayne Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References: