Emotional Awareness Therapy Study
Purpose
The purpose of this study is to learn about the potential benefits of two different training programs in helping improve emotional health and well-being in people who have had a traumatic brain injury. Participants will be assigned to one of two programs based on the time since their injury. One of the programs will teach participants how to recognize and label emotions; the other will teach healthy ways of living. Participants may improve their emotional well-being and contribute to the knowledge needed to achieve better emotional health outcomes for people with TBI. For eligible participants, the study includes 4 assessments. Assessments may take 30-60 minutes and will be done using secure videoconferencing, phone calls, and/or electronic surveys. The first assessment will ask questions about demographics, the participant's brain injury, and some medical history. All assessments will include questions about emotions, emotional awareness, resilience, loneliness, and how participants manage emotions, in addition to broader wellness questions and questions about how participants interact with others. Regardless of the program, the training includes 8 one-on-one sessions with a trained staff member over the course of about 1 month. Each session will last approximately 60-90 minutes. These sessions will start shortly after completing the first assessment. Preferably, participants will complete 1-2 training sessions a week, depending on availability and preference. These sessions will include education, discussion, and practice exercises. After the program is finished, participants will be asked to complete the same surveys completed at baseline for three follow-up time points (immediately following the program, 3 months after the program, and 6 months after). Total participation in the study will last approximately 8 months.
Condition
- Traumatic Brain Injury
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Moderate or Severe TBI - ≥18 years old - ≥6 months post-TBI - Speaks and understands English - Medications that can influence mood should be stable (6+ weeks) - Elevated alexithymia - Demonstrate an understanding of the study and their rights (e.g. ability to answer the following questions correctly after a review of the study details during pre-screening process)
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 - Active involvement in an intensive rehabilitation program - Individuals who recently started psychotherapy and/or mental health counseling
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Non-randomized design, participants who <12 months post TBI will be sequentially and alternatively assigned to either TREAT-A or TREAT-B programs; participants 12+ months post TBI will also be sequentially and alternatively assigned to either TREAT-A or TREAT-B programs.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TREAT-A |
Eight lessons delivered by a trained team member (interventionist) to the participant over ~4 weeks. It involves psycho-educational lessons and skill-building exercises to achieve the following objectives based on the characteristics of alexithymia.: 1) learn benefits of emotional awareness; 2) improve threshold for earlier detection of emotional responses; 3) label and differentiate emotions; 4) experience range of emotions; and 5) distinguish emotions from thoughts, actions and sensations. |
|
|
Active Comparator TREAT-B |
Provides education on TBI and overall brain health through instructional sessions, discussion, and structured tasks geared towards living healthy and improving general well-being. |
|
Recruiting Locations
Edison, New Jersey 08820
More Details
- Status
- Recruiting
- Sponsor
- Hackensack Meridian Health