Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Hackensack Meridian Health
Study ID
NCT07436754
Status
Recruiting
Apply to this trial

Conditions

  • Alexithymia
  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Program 1 — BEHAVIORAL
    Program 1 will teach participants how to recognize, label, and differentiate their emotions. The program will cover ways to reduce feeling "confused" or numb, and decrease the feelings of anger, stress and being overwhelmed.
  • Program 2 — BEHAVIORAL
    Program 2 will teach participants strategies to improve their overall brain health and functioning. It will also teach participants how to develop and work towards individualized short-term and long-term goals aimed at improving their quality of life.

Study Details

The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Program 1
    Enhance emotional awareness and ability to name, describe and express emotions with greater clarity, granularity and accuracy. Goals include enhancing participants' ability to: recognize and embrace the benefits of emotional awareness; detect onset of emotional responses early before escalation; accurately label and differentiate emotions; discern emotions from non-emotions; recognize and experience a larger breadth of emotions, including pleasant emotions.
  • Active Comparator: Program 2
    To promote general wellbeing and quality of life. Grounded in Health Belief Model emphasizing self-management and self-efficacy. Content includes topics relevant to living health with a TBI Contents were derived from the Traumatic Brain Injury Model Systems Knowledge Translation Center factsheets and topics recommended by the Consumer advisory panel.

Primary Outcome Measure

Toronto Alexithymia Scale-20 [ Time Frame: 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Amanda Melton
[email protected]
317-408-5589
Devan Parrott, PhD (PRINCIPAL_INVESTIGATOR)
National Intrepid Center Of ExcellenceBethesdaMaryland20889
Treven Pickett, PsyD
[email protected]
301-319-3670
Treven Pickett, PsyD (PRINCIPAL_INVESTIGATOR)
Hackensack Meridian Health - JFK Johnson Rehabilitation InstituteEdisonNew Jersey08820
Sarah Enock
[email protected]
732-606-5034
Dawn Neumann, PhD, FACRM (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By research site
Indiana University· Indianapolis, INNational Intrepid Center Of Excellence· Bethesda, MDHackensack Meridian Health - JFK Johnson Rehabilitation Institute· Edison, NJ

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