Traumatic Brain Injury
Conditions
Keywords
Emotional Health Training, Severe Traumatic Brain Injury, Moderate Traumatic Brain Injury
Brief summary
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.
Interventions
BEHAVIORALTREAT-A
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.
BEHAVIORALTREAT-B
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.
Sponsors
Hackensack Meridian Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ineligibility and Attrition Rates | Through study completion, an average of 8 months | 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). |
| Satisfaction Survey and Interview | immediate post-treatment | Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied |
| Interventionist Evaluation of Session Participation | intervention training sessions 1-8 (approximately 8 months) | Range: Min/Max = 6 to 24 Internal assessment completed by the interventionist at the end of each training session. |
| Patient Global Impression of Change (PGIC) emotional functioning and quality of life | immediate post-treatment | Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better. |
| Care-partner Global Impression of Change (CGIC) emotional functioning and quality of life | immediate post-treatment | Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Alexithymia Scale-20 | 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment. | Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad) |
| Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome) | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | Range: Min/ Max = 36 to 180 Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad) |
| Brief Resilience Scale | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | Range: Min/ Max = 6 to 30 Lower scores indicate worse resilience; higher scores indicate better resilience |
Countries
United States
Contacts
CONTACTGrace Wells, BS
PRINCIPAL_INVESTIGATORDawn Neumann, PhD, FACRM
Hackensack Meridian Health
Outcome results
None listed