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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREAT-A | Experimental | 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. |
|
| TREAT-B | Active Comparator | Provides education on TBI and overall brain health through instructional sessions, discussion, and structured tasks geared towards living healthy and improving general well-being. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TREAT-A | Behavioral | The TREAT-A program 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ineligibility and Attrition Rates | Data will be tracked on the number of individuals who were ineligible (and reasons for ineligibility) as well as withdrawals (reasons for withdrawal) and /or number of participants who become "lost" (no longer able to contact). | Through study completion, an average of 8 months |
| Satisfaction Survey and Interview | Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied | immediate post-treatment |
| Interventionist Evaluation of Session Participation | Range: Min/Max = 6 to 24 Internal assessment completed by the interventionist at the end of each training session. | intervention training sessions 1-8 (approximately 8 months) |
| Patient Global Impression of Change (PGIC) emotional functioning and quality of life | Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better. | immediate post-treatment |
| Care-partner Global Impression of Change (CGIC) emotional functioning and quality of life | Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better. | immediate post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Alexithymia Scale-20 | Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad) | 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment. |
| Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grace Wells, BS | Contact | 732-321-7000 | 68682 | grace.wells1@hmhn.org |
| Name | Affiliation | Role |
|---|---|---|
| Dawn Neumann, PhD, FACRM | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack Meridian Health - JFK Johnson Rehabilitation Institute | Recruiting | Edison | New Jersey | 08820 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| TREAT-B | Behavioral | The TREAT-B program 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. |
|
Range: Min/ Max = 36 to 180 Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad) |
| 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| Brief Resilience Scale | Range: Min/ Max = 6 to 30 Lower scores indicate worse resilience; higher scores indicate better resilience | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |