Online Emotion Regulation Group Intervention

NCT03479606 | Completed DMC

• 2 other identifiers: GCO 17-0988IRB-17-02795
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the efficacy of an emotion regulation intervention delivered online to individuals with traumatic brain injury (TBI) with deficits in emotion regulation. 104 subjects will be enrolled and will receive 24, 60-minute emotion regulation skills-training sessions twice a week for 12 weeks, delivered online in a group video-conference with 3-5 other participants. Participants will be asked to complete online surveys, lasting approximately 40-50 minutes, every four weeks during the intervention and the 12-week follow-up phase. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.

Conditions

Traumatic Brain Injury; Executive Dysfunction; Emotion Dysfunction; Emotion Dysregulation

Keywords

Traumatic Brain Injury; TBI; Executive Dysfunction; Emotional Regulation; Emotional Dysfunction; Problem Solving; Self-regulation; Cognitive Rehabilitation; Metacognitive Strategies; Cognitive-behavioral therapy; Online Therapy; GroupTherapy; 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.

  Every 4 weeks for 28 or 40 weeks

Secondary Outcomes (7)

• Positive Affect Negative Affect Schedule (PANAS)

  Every 4 weeks for 28 or 40 weeks

• Satisfaction with Life Scale (SWLS)

  Every 4 weeks for 28 or 40 weeks

• Problem Solving Inventory (PSI)

  Every 4 weeks for 28 or 40 weeks

• Dysexecutive Functioning Questionnaire (DEX)

  Every 4 weeks for 28 or 40 weeks

• Transition Ratings (TR)

  End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention

Other Outcomes (1)

• Access to Care Questionnaire (ACQ)

  Baseline

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Participants will receive 24 online emotional regulation skills-training sessions twice weekly and will complete online questionnaires sent every four weeks throughout baseline, the 12-week intervention, and 12-week follow-up.

Behavioral: Online Emotion Regulation Skills-training

Waitlist Intervention

ACTIVE COMPARATOR

After a 12-week wait-period without any intervention, participants will receive 24 online emotion regulation skills-training sessions. Every four weeks, participants will complete online questionnaires every throughout baseline, 12-week wait-period, 12-week intervention, and 12-week follow-up.

Behavioral: Online Emotion Regulation Skills-training

Interventions

Online Emotion Regulation Skills-training BEHAVIORAL

Emotion Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation. The intervention 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 intervention, to increase their familiarity with the terminology, and to the emotion regulation skills they acquire during the practice facilitation phase. During the practice facilitation phase participants receive training in emotion 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: Emotion Regulation Training (EmReg)

Immediate Intervention; Waitlist Intervention

Eligibility Criteria

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

You may qualify if:

• medically documented mild to severe TBI
• at least 6 months post-injury
• deficits in emotional regulation (ER), operationalized as a score of 0.5 standard deviations above published means on the Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004)
• English speaking
• adequate communication skills, assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
• access to and ability to use a device that supports GoToMeeting/Zoom, the videoconference software
• active email address
• access to the Internet with adequate broadband
• Lives in the following states for the duration of the 12-week intervention: New York, California, Maryland, North Carolina, Georgia, Missouri, Arizona, New Jersey, Colorado, Florida, or Washington DC

You may not qualify if:

• current alcohol or substance abuse
• current psychotic disorder, mood disorder with psychotic features or current suicidality, assessed by the Mini International Neuropsychiatric Interview

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

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

• Maria Kajankova, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Kristen Dams-O'Connor, PhD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Theodore Tsaousides, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 27, 2018
• Study Start: April 5, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)