Health TrialsbyHealthPanel

Emotional Awareness Therapy Study

ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Moderate or Severe TBI

≥18 years old

≥6 months post-TBI

Speaks and understands English

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: TREAT-AExperimental treatment 1 intervention
Group B: TREAT-BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Through study completion, an average of 8 months
2

Satisfaction Survey and Interview

Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied

Time frame
immediate post-treatment
3

Interventionist Evaluation of Session Participation

Range: Min/Max = 6 to 24 Internal assessment completed by the interventionist at the end of each training session.

Time frame
intervention training sessions 1-8 (approximately 8 months)
4

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.

Time frame
immediate post-treatment

Secondary outcomes

1

Toronto Alexithymia Scale-20

Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)

Time frame
1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.
2

Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)

Range: Min/ Max = 36 to 180 Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)

Time frame
1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
3

Brief Resilience Scale

Range: Min/ Max = 6 to 30 Lower scores indicate worse resilience; higher scores indicate better resilience

Time frame
1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hackensack Meridian Health

Lead sponsor

Source ClinicalTrials.gov
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