Well-being Interventions for Adults with Traumatic Brain Injury

This study is looking at two different web-based programs for adults who have had a moderate to severe traumatic brain injury (TBI) at least one year ago. One program, called "Signature Strengths," helps you learn about and use your personal strengths to improve your well-being. The other program, "TBI Education Course," provides information about TBI. Researchers want to see if these programs can improve how you feel about yourself and other important outcomes over time. To join, you must be at least 18 years old, speak and read English, and not have certain other medical conditions like multiple sclerosis or a history of seizures. The study aims to enroll 94 participants.

Study design
This is an interventional study with an unspecified phase, comparing two behavioral interventions. It plans to enroll 94 participants.
What's involved
You would complete 6 web-based sessions, one per week for 6 weeks, each lasting about 60 minutes. Your self-esteem and other measures will be checked at the start, 3 months, and 6 months after the study begins.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the start of the study to measure outcomes.

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NCT05943756

Evaluation of Well-being Interventions in Adults With TBI

Recruiting
NAAges 18+InterventionalTreatment
Kessler Foundation
~94 participants
Updated 2025-01-17 on ClinicalTrials.gov
What's tested:Signature StrengthsTBI Education Course

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rosenberg Self-Esteem Scale (RSES)
Measured over Baseline, 3 months posttest, and 6 months posttest
+4 more outcomes measured
TBI (Traumatic Brain Injury)
1 sites across 1 states
New Jersey1
  • Helen Genova, Ph. D. · PRINCIPAL_INVESTIGATOR · Kessler Foundation

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Eligibility criteria

Inclusion

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

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
  • Rosenberg Self-Esteem Scale (RSES)Baseline, 3 months posttest, and 6 months posttest

    Self-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 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.

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

  • Global Assessment of Character StrengthsBaseline, 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.

  • Twenty-Statements TaskBaseline, 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.