TBI (Traumatic Brain Injury)NCT05943756
Evaluation of Well-being Interventions in Adults With TBI
A study testing Signature Strengths and TBI Education Course in people with TBI (Traumatic Brain Injury), run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Signature Strengths and TBI Education Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Helen M Genova, Ph.D., hgenova@kesslerfoundation.org
About this study
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.
Read the 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.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Signature Strengths, TBI Education Course
- Keywords
- TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signature StrengthsBehavioural
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.
TBI Education CourseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Signature Strengths | Experimental | In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury. Receives: Behavioral: Signature Strengths |
| TBI Education Course | Active comparator | In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury. Receives: Behavioral: TBI Education Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosenberg Self-Esteem Scale (RSES)
Self-report self-esteem questionnaire. Values range from 10-40, with higher score indicating better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Strengths Knowledge and Strengths Use Scale (SKUS)
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.
Measured: Baseline, 3 months posttest, and 6 months posttest
Head Injury Semantic Differential Scale - Version III (HISD-III)
Self-report for examination of past and present self-identity. Values range from 18-126, with higher score indicating a better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Global Assessment of Character Strengths
24-item questionnaire to rate levels of individual's character strengths. Values range from 24-120, with higher score indicating a better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Twenty-Statements Task
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.
Measured: Baseline, 3 months posttest, and 6 months posttest
Secondary outcomes (8)
Flourishing Scale (FS)
Measure of well-being and "flourishing". Values range from 8-56, with higher score indicating a better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Quality of Life After Brain Injury (QOLIBRI)
Assess Quality of Life specifically in Brain Injury. Values range from 0-100, with higher score indicating a better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Satisfaction with Life Scale (SWLS)
Measure of life satisfaction. Values range from 5-35, with higher score indicating a better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Positive and Negative Affect Schedule (PANAS)
Measure of both positive and negative emotional feelings. Values range from 10-50, with higher score indicating a better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Voicemail Elicitation Task
Measures 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.
Measured: Baseline, 3 months posttest, and 6 months posttest
Perceived Stress Scale
10 item, Self-report measure of perceived stress. Values range from 0-40, with higher score indicating a worse outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Connor-Davidson Resilience Scale 10 (CD-RISC-10)
10 item self-report measure of resilience. Values range from 0-40, with higher score indicating a better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Brain Injury Self-Efficacy Scale
20 item self-report measure of self-efficacy and coping. Values range from 0-80, with higher score indicating a better outcome.
Measured: Baseline, 3 months posttest, and 6 months posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start25 Sep 2023
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both groups will participate in a different intervention program meant to improve well-being in individuals who have sustained a brain injury.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Genova, Ph. D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943756
- Sponsor's protocol ID
- E-1220-23
- Status last verified
- Jan 2025
- First submitted
- 5 Jul 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Well-being Interventions in Adults With TBI
- ClinicalTrials.gov ID
- NCT05943756
- Acronym / sponsor ID
- E-1220-23
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Both groups will participate in a different intervention program meant to improve well-being in individuals who have sustained a brain injury.
| Arm | Type | Receives |
|---|---|---|
| Signature Strengths | Experimental | Behavioral: Signature StrengthsIn this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury. |
| TBI Education Course | Active comparator | Behavioral: TBI Education CourseIn this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signature StrengthsThe 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. | Behavioural | Signature Strengths |
| TBI Education CourseThe 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. | Behavioural | TBI Education Course |
Primary 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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen Genova, Ph. D. principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signature Strengths and TBI Education Course in people with TBI (Traumatic Brain Injury), run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Genova, Ph. D. (973-324-8390, hgenova@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rosenberg Self-Esteem Scale (RSES) (time frame: Baseline, 3 months posttest, and 6 months posttest). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.