Menu
Recruiting NCT05943756

Evaluation of Well-being Interventions in Adults With TBI

No phase Interventional TBI (Traumatic Brain Injury)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Signature Strengths, TBI Education Course.
Who it may be relevant to
Registry conditions: TBI (Traumatic Brain Injury). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Behavioral Signature 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.
  • Behavioral TBI 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.

Primary outcome measures

  • Rosenberg Self-Esteem Scale (RSES) [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Strengths Knowledge and Strengths Use Scale (SKUS) [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Head Injury Semantic Differential Scale - Version III (HISD-III) [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Global Assessment of Character Strengths [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Twenty-Statements Task [Time frame: Baseline, 3 months posttest, and 6 months posttest]
Secondary outcome measures (8)
  • Flourishing Scale (FS) [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Quality of Life After Brain Injury (QOLIBRI) [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Satisfaction with Life Scale (SWLS) [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Positive and Negative Affect Schedule (PANAS) [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Voicemail Elicitation Task [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Perceived Stress Scale [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Connor-Davidson Resilience Scale 10 (CD-RISC-10) [Time frame: Baseline, 3 months posttest, and 6 months posttest]
  • Brain Injury Self-Efficacy Scale [Time frame: Baseline, 3 months posttest, and 6 months posttest]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Kessler Foundation — East Hanover

Identifiers

NCT: NCT05943756 · E-1220-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗