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Recruiting
NCT07436754
Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury
Conditions: Mild Traumatic Brain Injury, Alexithymia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Hackensack Meridian Health
Location: Indiana University Indianapolis Indiana
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Mild TBI
* ≥18 years old
* ≥6 months post-TBI
* Elevated alexithymia and emotion dysregulation
* Capacity to consent
* Speaks and understands English
* Personal device capable of video conferencing and internet
Exclusion Criteria:
* Premorbid neurological disorder other than TBI
* Degenerative neurologic condition
* Active or uncontrolled major psychiatric disorder
* Conditions that pose safety concern to self or others, such as suicide risk
* Previous psychiatric hospitalization
* Visual, hearing, communication, or cognitive impairments that would impede participation
* Unstable medications (e.g., started \< 6 weeks prior to enrollment) or anticipated medication changes that will influence mood/ affect during study participation
* Active involvement in an intensive rehabilitation program
* Individuals who recently started psychotherapy and/or mental health counseling (e.g., \
Source: ClinicalTrials.gov (NCT07436754). StuddyBuddy aggregates publicly available trial information.