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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 1 of 3 sites
    • Eligibility criteria expanded, about 3 words
    v3
  2. Recruitment opened
    • Start date changed from estimate of Mar 30, 2026 to May 20, 2026
    • Site details revised at 3 of 3 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07436754
Lead Sponsor Hackensack Meridian Health
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Mild Traumatic Brain Injury, Alexithymia
Related terms Affective Symptoms, Brain Concussion
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov