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Online Emotion Regulation Group Intervention

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ClinicalTrials.gov Identifier: NCT03479606
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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 3-4 other participants. Participants will be asked to complete an online survey, lasting approximately 40-50 minutes, every four weeks during the intervention and 12-week follow-up phase. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Executive Dysfunction Emotional Dysfunction Behavioral: Online Emotion Regulation Skills-training Not Applicable

Detailed Description:

This study will assess the efficacy of an emotion regulation skills-training intervention (Online EmReg) provided online to individuals with TBI with emotion regulation difficulties. Specifically, this study seeks to accomplish three aims: 1) Evaluate the efficacy of the Online EmReg intervention immediately post-intervention and at a 12-week follow-up assessment; 2) Identify factors that optimize the effectiveness of the Online EmReg intervention; 3) Explore the impact of Online EmReg on positive and negative affect, life satisfaction, and executive functioning. The study design is a randomized control trial with a waitlist control group whereby the participants in the control group undergo the training after a 12 week waiting period. 104 subjects with TBI and self-reported deficits in emotion regulation will be enrolled.

The intervention protocol calls for 24, 60-minute emotion regulation sessions twice a week for 12 weeks, delivered online via GoToMeeting by post-doctoral level therapists with specialty training in rehabilitation neuropsychology. Study participation will last approximately 28 weeks for participants in the immediate intervention arm (4 weeks preparation, 12 weeks intervention, 12 weeks follow-up) and 40 weeks for participants in the waitlist arm (4 weeks preparation, 12 weeks waitlist, 12 weeks intervention, and 12 weeks follow-up). Core assessments will be conducted at each major time point: T1 (baseline), T2 (immediate intervention end/waitlist baseline), T3 (immediate intervention follow-up/end of waitlist intervention), and T4 (waitlist follow-up). A subset of the measures will be administered every 4 weeks between each major time point for the duration of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Controlled Trial of an Online Emotion Regulation Intervention Following TBI
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Arm Intervention/treatment
Experimental: Immediate Intervention
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
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.
Other Name: Emotion Regulation Training (EmReg)

Active Comparator: Waitlist Intervention
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
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.
Other Name: Emotion Regulation Training (EmReg)




Primary Outcome Measures :
  1. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Every 4 weeks for 28 or 40 weeks ]
    36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies.


Secondary Outcome Measures :
  1. Positive Affect Negative Affect Schedule (PANAS) [ Time Frame: Every 4 weeks for 28 or 40 weeks ]
    A 20-item measure with two independent scales, positive affect and negative affect.

  2. Satisfaction with Life Scale (SWLS) [ Time Frame: Every 4 weeks for 28 or 40 weeks ]
    A 5-item measure of satisfaction with life globally.

  3. Problem Solving Inventory (PSI) [ Time Frame: Every 4 weeks for 28 or 40 weeks ]
    A 35-item self-report measure assessing problem solving behavior and attitudes, the PSI yields 3 subscales: Approach/Avoidance Style, Problem Solving Confidence, and Presence of Personal Control.

  4. Dysexecutive Functioning Questionnaire (DEX) [ Time Frame: Every 4 weeks for 28 or 40 weeks ]
    A 20-item sensitive and ecologically valid questionnaire assessing everyday problems.

  5. Transition Ratings (TR) [ Time Frame: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention ]
    These ratings are used to assess change on problems that are intervention targets, from the participant's point of view, by reporting how much better/worse the problem seems to be since the onset of the intervention.

  6. Progress Toward Goals (PTG) [ Time Frame: Every 4 weeks for 28 weeks ]
    During the first 2 sessions, participants will be asked to set three to five personal goals related to emotional regulation and its impact on their daily lives, and then asked to rate their progress towards these goals on a 7-point Likert scale.

  7. Skill Acquisition Quiz (SAQ) [ Time Frame: End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention ]
    A 20-question content-based quiz developed to assess how well participants learn and retain EmReg concepts and strategies by intervention end.


Other Outcome Measures:
  1. Access to Care Questionnaire (ACQ) [ Time Frame: Baseline ]
    A brief questionnaire to assess participants' access to rehabilitation services using modified items borrowed from national health surveys.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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, the videoconference software
  • active email address
  • access to the Internet with adequate broadband
  • Lives in New York State for duration of study

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479606


Contacts
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Contact: Sabina Young, BA 212-241-4886 Sabina.young@mountsinai.org

Locations
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United States, New York
The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Maria Kajankova, PhD    212-241-3379    maria.kajankova@mountsinai.org   
Contact: Kristen Dams-O'Connor, PhD    212-241-7587    kristen.dams-o'connor@mountsinai.org   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Principal Investigator: Maria Kajankova, PhD Icahn School of Medicine at Mount Sinai
Study Director: Kristen Dams-O'Connor, PhD Icahn School of Medicine at Mount Sinai
Principal Investigator: Theodore Tsaousides, PhD Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03479606     History of Changes
Other Study ID Numbers: GCO 17-0988
IRB-17-02795 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Traumatic Brain Injury
Cognitive Rehabilitation
TBI
Executive Dysfunction
Emotional Regulation
Emotional Dysfunction
Problem Solving
Self-regulation
Metacognitive Strategies
Cognitive-behavioral therapy
Online Therapy
GroupTherapy
Group videoconference
Telehealth
Telerehabilitation

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries