Teletherapy Programs for Brain Injury and Emotional Health
This study is comparing two different teletherapy programs to see which one is better at helping people who have had a mild traumatic brain injury (mTBI), also known as a concussion. The programs aim to improve emotional health, especially for those who have difficulty recognizing and expressing emotions (alexithymia) and managing their feelings. Program 1 teaches you how to understand and manage your emotions, while Program 2 focuses on improving overall brain health and setting personal goals. The study is looking for 300 participants aged 18 or older who had an mTBI at least six months ago and have emotional difficulties. Success will be measured by changes in how participants identify and regulate their emotions. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 300 participants. It compares two behavioral programs delivered remotely.
- What's involved
- You would participate for about 8 months total, with 4 assessment visits and 8 one-on-one training sessions. The training sessions are about 60-90 minutes each, completed over approximately one month.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have assessment visits immediately after treatment, and then at 3 months and 6 months post-treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Dawn Neumann, PhD, FACRM · PRINCIPAL_INVESTIGATOR · Hackensack Meridian Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Toronto Alexithymia Scale-201) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.
his widely used alexithymia assessment (including the TBI population), is comprised of 3 factors: 1) ability to identify emotions); 2) ability to describe emotions; and 3) externally-oriented thinking. In addition to being a co-primary outcome measure, the TAS-20 scores will be used to determine eligibility (\>.5 SD above published means). It is a CDE and a PhenX toolkit measure has good psychometric properties, including good test-retest reliability. Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)
- Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
This commonly used measure of emotion dysregulation, uses a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, test-retest reliability, and good construct validity.56 Will be used to evaluate emotion dysregulation and to determine eligibility (\>.5 SD above published means). Range: Min/ Max = 36 to 180. Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)