NCT01730261|CompletedPhase 1
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Sponsor study identifier
Secondary identifiers
interventional
147
1 country
1
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 15, 2012
Actual (reported)November 21, 2012
Actual (reported)October 2015
Actual (reported)October 2015
Actual (reported)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
The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
up to 28 weeks
Problem Solving Inventory
up to 28 weeks
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Wayne Gordon, PhD
Icahn School of Medicine at Mount Sinai
147 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2012
First Posted
November 21, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Neural Basis of Decision-Making Deficits in Traumatic Brain Injury
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)
Contact the study team to confirm eligibility.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
October 2, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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