NCT05943756 · Kessler Foundation
Evaluation of Well-being Interventions in Adults With TBI
What this study is about
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.
View original scientific description
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.
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
Self-report self-esteem questionnaire. Values range from 10-40, with higher score indicating better outcome.
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- East Hanover, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 17, 2025 · Source of record for eligibility and locations