Clinical trial NCT05943756: Evaluation of Well-being Interventions in Adults With TBI
Official title: Evaluation of Well-being Interventions in Adults With TBI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Keywords: TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both groups will participate in a different intervention program meant to improve well-being in individuals who have sustained a brain injury.
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate the potential benefits of two Intervention programs in adults with TBI to improve well-being and other outcomes that are maintained over time.

Detailed description: The current study will examine the efficacy of Signature Strengths in adults with TBI to improve self-concept and other outcomes that are maintained over time. Preliminary evidence suggests that after a TBI, an individual can experience significant alteration to their personal identity and a perceived loss of their pre-injury self. By using this Signature Strength intervention, adults with moderate to severe TBI will be able to become aware of their most used "signature" strengths, explore how these strengths are used in everyday life, and apply them in future situations to bring well-being and to better cope with stressors.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Have a diagnosis with moderate to severe TBI
* At least one year post injury
* Able to speak and read English fluently

Exclusion Criteria:

* Have a history of multiple sclerosis, stroke, seizures or another nervous system injuries disease in the past (like brain tumor or epilepsy)
* Have a significant psychiatric illness (like, schizophrenia or psychosis)
* Currently taking steroids and/or benzodiazepines as determined by study staff review of medications
* Significant alcohol or drug abuse history (requiring inpatient treatment)
* History of stroke, schizoaffective disorder, bipolar disorder, personality disorder or severe depression determined by extensive screening by a trained staff member
* Previous participation in a Signature Strengths program

Primary outcomes:
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Strengths Knowledge and Strengths Use Scale (SKUS)
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Head Injury Semantic Differential Scale - Version III (HISD-III)
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Global Assessment of Character Strengths
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Twenty-Statements Task
timeFrame: Baseline, 3 months posttest, and 6 months posttest
Secondary outcomes:
measure: Flourishing Scale (FS)
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Quality of Life After Brain Injury (QOLIBRI)
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Voicemail Elicitation Task
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Perceived Stress Scale
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Connor-Davidson Resilience Scale 10 (CD-RISC-10)
timeFrame: Baseline, 3 months posttest, and 6 months posttest
measure: Brain Injury Self-Efficacy Scale
timeFrame: Baseline, 3 months posttest, and 6 months posttest
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Helen Genova, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: