Emotional Awareness Therapy Study (TREAT)
A Feasibility Study Exploring Emotional Health Training After Moderate to Severe Traumatic Brain Injury
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Grace Wells, BS
- Numéro de téléphone: 68682 732-321-7000
- E-mail: grace.wells1@hmhn.org
Lieux d'étude
-
-
New Jersey
-
Edison, New Jersey, États-Unis, 08820
- Recrutement
- Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
-
Chercheur principal:
- Dawn Neumann, PhD, FACRM
-
Contact:
- Grace Wells, BS
- Numéro de téléphone: 68682 732-321-7000
- E-mail: grace.wells1@hmhn.org
-
Contact:
- Sarah Enock, BS
- Numéro de téléphone: 848-893-6577
- E-mail: tbiresearchjfkjri@hmhn.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ineligibility and Attrition Rates
Délai: 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).
|
Through study completion, an average of 8 months
|
|
Satisfaction Survey and Interview
Délai: immediate post-treatment
|
Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied
|
immediate post-treatment
|
|
Interventionist Evaluation of Session Participation
Délai: 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.
|
intervention training sessions 1-8 (approximately 8 months)
|
|
Patient Global Impression of Change (PGIC) emotional functioning and quality of life
Délai: immediate post-treatment
|
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
Délai: immediate post-treatment
|
Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.
|
immediate post-treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Toronto Alexithymia Scale-20
Délai: 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)
|
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)
Délai: 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)
|
1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
|
|
Brief Resilience Scale
Délai: 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
|
1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Dawn Neumann, PhD, FACRM, Hackensack Meridian Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro2026-0081
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .