Online Emotional Regulation Group Treatment

NCT01730261 | Completed Phase 1

• 3 other identifiers: GCO 12-1256-3HSM 12-00760IF1435434
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)

  up to 28 weeks

• Problem Solving Inventory

  up to 28 weeks

• Social Problem Solving Inventory-Revised: Short Form

  up to 28 weeks

• Positive Affect Negative Affect Scale

  up to 28 weeks

• Satisfaction with Life Scale

  T1 (baseline)

Study Arms (1)

Online Emotional Regulation Treatment

EXPERIMENTAL

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

Behavioral: Online Emotional Regulation Treatment

Interventions

Online Emotional Regulation Treatment BEHAVIORAL

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.

Also known as: Emotional Regulation Training (EmReg)

Online Emotional Regulation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

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

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Emotional Regulation; Self-Control

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Social Behavior; Behavior

Study Officials

• Wayne Gordon, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

US (1)