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Completed

NCT Number: NCT01730261

Online Emotional Regulation Group Treatment

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.

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Key information

Conditions

Traumatic Brain Injury Behavior Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Emotional Dysregulation Emotional Regulation Executive Dysfunction Nervous System Diseases Self-Control Social Behavior Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Emotional Regulation Training (EmReg)

Primary outcomes

  1. Difficulties in Emotion Regulation Scale(DERS)

    Time frame: 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 outcomes

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

    Time frame: up to 28 weeks

    32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI

  2. Problem Solving Inventory

    Time frame: up to 28 weeks

    35-item self-report questionnaire assessing problem solving capability

  3. Social Problem Solving Inventory-Revised: Short Form

    Time frame: up to 28 weeks

    25-item self-report questionnaire assessing problem solving in everyday living

  4. Positive Affect Negative Affect Scale

    Time frame: up to 28 weeks

    20-item self-report measure of positive and negative affect within a specified time frame

  5. Satisfaction with Life Scale

    Time frame: T1 (baseline)

    5- item measure of global satisfaction with life

  6. Satisfaction with Life Scale

    Time frame: T2 (week 4)

    5- item measure of global satisfaction with life

  7. Satisfaction with Life Scale

    Time frame: T3 (week 16)

    5- item measure of global satisfaction with life

  8. Satisfaction with Life Scale

    Time frame: T4 (week 28)

    5- item measure of global satisfaction with life

  9. Satisfaction with Therapy and Therapist Scale

    Time frame: T3 (week 16)

    12-item scale that assesses satisfaction with treatment and therapist

  10. Satisfaction with Therapy and Therapist Scale

    Time frame: T4 (week 28)

    12-item scale that assesses satisfaction with treatment and therapist

  11. Treatment Compliance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2012
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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