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Online Emotion Regulation Skills-training for Traumatic Brain Injury

N/A
Waitlist Available
Led By Maria Kajankova, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks for 28 or 40 weeks
Awards & highlights

Study Summary

This trial will study whether an emotion regulation intervention delivered online can help people with TBI who have difficulty regulating their emotions. 104 subjects will participate in 24, 60-minute sessions over 12 weeks, delivered via video conference in groups of 3-5 people. Data will be collected online every four weeks to monitor outcomes.

Eligible Conditions
  • Executive Dysfunction
  • Emotional Dysfunction
  • Emotional Dysregulation
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difficulties in Emotion Regulation Scale (DERS)
Secondary outcome measures
Dysexecutive Functioning Questionnaire (DEX)
Positive Affect Negative Affect Schedule (PANAS)
Problem Solving Inventory (PSI)
+4 more
Other outcome measures
Access to Care Questionnaire (ACQ)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate InterventionExperimental Treatment1 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.
Group II: Waitlist InterventionActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Online Emotion Regulation Skills-training
2018
N/A
~140

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,149 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
8,992 Total Patients Enrolled
Maria Kajankova, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
815 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Online Emotion Regulation Group Intervention
Kristen Dams-O'Connor 2018. "Online Emotion Regulation Group Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03479606.
~20 spots leftby Apr 2025
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