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Clinical Trials/NCT05943756
NCT05943756
Recruiting
Not Applicable

Evaluation of Well-being Interventions in Adults With TBI

Kessler Foundation1 site in 1 country94 target enrollmentSeptember 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
TBI (Traumatic Brain Injury)
Sponsor
Kessler Foundation
Enrollment
94
Locations
1
Primary Endpoint
Strengths Knowledge and Strengths Use Scale (SKUS)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 25, 2023
End Date
June 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Strengths Knowledge and Strengths Use Scale (SKUS)

Time Frame: Baseline, 3 months posttest, and 6 months posttest

Measure 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.

Global Assessment of Character Strengths

Time Frame: Baseline, 3 months posttest, and 6 months posttest

24-item questionnaire to rate levels of individual's character strengths. Values range from 24-120, with higher score indicating a better outcome.

Rosenberg Self-Esteem Scale (RSES)

Time Frame: Baseline, 3 months posttest, and 6 months posttest

Self-report self-esteem questionnaire. Values range from 10-40, with higher score indicating better outcome.

Head Injury Semantic Differential Scale - Version III (HISD-III)

Time Frame: Baseline, 3 months posttest, and 6 months posttest

Self-report for examination of past and present self-identity. Values range from 18-126, with higher score indicating a better outcome.

Twenty-Statements Task

Time Frame: Baseline, 3 months posttest, and 6 months posttest

20-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 Outcomes

  • Satisfaction with Life Scale (SWLS)(Baseline, 3 months posttest, and 6 months posttest)
  • Connor-Davidson Resilience Scale 10 (CD-RISC-10)(Baseline, 3 months posttest, and 6 months posttest)
  • Flourishing Scale (FS)(Baseline, 3 months posttest, and 6 months posttest)
  • Voicemail Elicitation Task(Baseline, 3 months posttest, and 6 months posttest)
  • Perceived Stress Scale(Baseline, 3 months posttest, and 6 months posttest)
  • Quality of Life After Brain Injury (QOLIBRI)(Baseline, 3 months posttest, and 6 months posttest)
  • Positive and Negative Affect Schedule (PANAS)(Baseline, 3 months posttest, and 6 months posttest)
  • Brain Injury Self-Efficacy Scale(Baseline, 3 months posttest, and 6 months posttest)

Study Sites (1)

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