Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury
Purpose
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.
Conditions
- Mild Traumatic Brain Injury
- Alexithymia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 - 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., <3 months prior)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
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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. |
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Recruiting Locations
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
Edison, New Jersey 08820
Edison, New Jersey 08820
More Details
- Status
- Recruiting
- Sponsor
- Hackensack Meridian Health