Online Emotional Regulation Group Treatment

Phase 1

Completed

• Conditions: Emotional Dysregulation; Executive Dysfunction; Traumatic Brain Injury
• Interventions: Behavioral: Online Emotional Regulation Treatment

• Registration Number: NCT01730261
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-21
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Online Emotional Regulation Treatment	Online Emotional Regulation Treatment	Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments

Primary Outcome Measures

Name	Time	Method
Difficulties in Emotion Regulation Scale(DERS)	up to 28 weeks	36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies

Secondary Outcome Measures

Name	Time	Method
Social Problem Solving Inventory-Revised: Short Form	up to 28 weeks	25-item self-report questionnaire assessing problem solving in everyday living
The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)	up to 28 weeks	32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI
Satisfaction with Life Scale	T4 (week 28)	5- item measure of global satisfaction with life
Satisfaction with Therapy and Therapist Scale	T4 (week 28)	12-item scale that assesses satisfaction with treatment and therapist
Positive Affect Negative Affect Scale	up to 28 weeks	20-item self-report measure of positive and negative affect within a specified time frame
Problem Solving Inventory	up to 28 weeks	35-item self-report questionnaire assessing problem solving capability
Treatment Compliance	up to 28 weeks	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

Trial Locations

Locations (1)

The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States