Online Emotional Regulation Group Treatment

Traumatic Brain Injury Clinical Trial

Official title:

Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730261
• Other study ID #: GCO 12-1256-3
• Secondary ID: HSM 12-00760IF14
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2012
• Last updated: October 1, 2015
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Emotional Dysregulation
• Executive Dysfunction
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 28 weeks	No
Secondary	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	up to 28 weeks	No
Secondary	Problem Solving Inventory	35-item self-report questionnaire assessing problem solving capability	up to 28 weeks	No
Secondary	Social Problem Solving Inventory-Revised: Short Form	25-item self-report questionnaire assessing problem solving in everyday living	up to 28 weeks	No
Secondary	Positive Affect Negative Affect Scale	20-item self-report measure of positive and negative affect within a specified time frame	up to 28 weeks	No
Secondary	Satisfaction with Life Scale	5- item measure of global satisfaction with life	T1 (baseline)	No
Secondary	Satisfaction with Life Scale	5- item measure of global satisfaction with life	T2 (week 4)	No
Secondary	Satisfaction with Life Scale	5- item measure of global satisfaction with life	T3 (week 16)	No
Secondary	Satisfaction with Life Scale	5- item measure of global satisfaction with life	T4 (week 28)	No
Secondary	Satisfaction with Therapy and Therapist Scale	12-item scale that assesses satisfaction with treatment and therapist	T3 (week 16)	No
Secondary	Satisfaction with Therapy and Therapist Scale	12-item scale that assesses satisfaction with treatment and therapist	T4 (week 28)	No
Secondary	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	up to 28 weeks	No