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Evaluation of Well-being Interventions in Adults With TBI

Evaluation of Well-being Interventions in Adults With TBI

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05943756
Enrollment
94
Registered
2023-07-13
Start date
2023-09-25
Completion date
2026-06-30
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI (Traumatic Brain Injury)

Keywords

TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury

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.

Interventions

BEHAVIORALSignature Strengths

The treatment group will complete 6 web-based sessions of Signature Strengths(1 sessions per week for 6 weeks), designed to teach lessons focused on the Aware-Explore-Apply interventional framework. Sessions are approximately 60 minutes long.

BEHAVIORALTBI Education Course

The control group will complete 6 web-based sessions of a TBI Education Course(1 sessions per week for 6 weeks), designed to teach lessons based on the TBI Model Systems Knowledge Translation Center's fact sheets. Sessions are approximately 60 minutes long.

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rosenberg Self-Esteem Scale (RSES)Baseline, 3 months posttest, and 6 months posttestSelf-report self-esteem questionnaire. Values range from 10-40, with higher score indicating better outcome.
Strengths Knowledge and Strengths Use Scale (SKUS)Baseline, 3 months posttest, and 6 months posttestMeasure to assess knowledge and use of one's strengths and measure changes following strengths-based interventions. Two scores: Strengths Use and Strengths Knowledge. Strengths Use values range from 14-98, with higher score indicating a better outcome. Strengths Knowledge values range from 8-56, with higher score indicating a better outcome.
Head Injury Semantic Differential Scale - Version III (HISD-III)Baseline, 3 months posttest, and 6 months posttestSelf-report for examination of past and present self-identity. Values range from 18-126, with higher score indicating a better outcome.
Global Assessment of Character StrengthsBaseline, 3 months posttest, and 6 months posttest24-item questionnaire to rate levels of individual's character strengths. Values range from 24-120, with higher score indicating a better outcome.
Twenty-Statements TaskBaseline, 3 months posttest, and 6 months posttest20-item questionnaire used to measure an individual's self concept filling out the twenty items that each start with the words I am... which will be analyzed for positive and negative valence, with higher score indicating a better outcome. There is no maximum or minimum value for this test.

Secondary

MeasureTime frameDescription
Perceived Stress ScaleBaseline, 3 months posttest, and 6 months posttest10 item, Self-report measure of perceived stress. Values range from 0-40, with higher score indicating a worse outcome.
Flourishing Scale (FS)Baseline, 3 months posttest, and 6 months posttestMeasure of well-being and flourishing. Values range from 8-56, with higher score indicating a better outcome.
Brain Injury Self-Efficacy ScaleBaseline, 3 months posttest, and 6 months posttest20 item self-report measure of self-efficacy and coping. Values range from 0-80, with higher score indicating a better outcome.
Connor-Davidson Resilience Scale 10 (CD-RISC-10)Baseline, 3 months posttest, and 6 months posttest10 item self-report measure of resilience. Values range from 0-40, with higher score indicating a better outcome.
Quality of Life After Brain Injury (QOLIBRI)Baseline, 3 months posttest, and 6 months posttestAssess Quality of Life specifically in Brain Injury. Values range from 0-100, with higher score indicating a better outcome.
Satisfaction with Life Scale (SWLS)Baseline, 3 months posttest, and 6 months posttestMeasure of life satisfaction. Values range from 5-35, with higher score indicating a better outcome.
Positive and Negative Affect Schedule (PANAS)Baseline, 3 months posttest, and 6 months posttestMeasure of both positive and negative emotional feelings. Values range from 10-50, with higher score indicating a better outcome.
Voicemail Elicitation TaskBaseline, 3 months posttest, and 6 months posttestMeasures how individuals respond to social situations using politeness/impoliteness. Values are calculated by dividing the total number of politeness markers by the total time in minutes, with a higher score indicating a better outcome. There are no minimum or maximum values for this test.

Countries

United States

Contacts

Primary ContactHelen Genova, Ph. D.
hgenova@kesslerfoundation.org973-324-8390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026