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NCT Number: NCT05943756

Evaluation of Well-being Interventions in Adults With TBI

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.

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Key information

Conditions

TBI (Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location status: Recruiting

Location contact

Helen M Genova, Ph.D.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Signature Strengths

Behavioral

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 Course

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. Flourishing Scale (FS)

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

    Measure of well-being and "flourishing". Values range from 8-56, with higher score indicating a better outcome.

  2. Quality of Life After Brain Injury (QOLIBRI)

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

    Assess Quality of Life specifically in Brain Injury. Values range from 0-100, with higher score indicating a better outcome.

  3. Satisfaction with Life Scale (SWLS)

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

    Measure of life satisfaction. Values range from 5-35, with higher score indicating a better outcome.

  4. Positive and Negative Affect Schedule (PANAS)

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

    Measure of both positive and negative emotional feelings. Values range from 10-50, with higher score indicating a better outcome.

  5. Voicemail Elicitation Task

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

    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.

  6. Perceived Stress Scale

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

    10 item, Self-report measure of perceived stress. Values range from 0-40, with higher score indicating a worse outcome.

  7. Connor-Davidson Resilience Scale 10 (CD-RISC-10)

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

    10 item self-report measure of resilience. Values range from 0-40, with higher score indicating a better outcome.

  8. Brain Injury Self-Efficacy Scale

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

    20 item self-report measure of self-efficacy and coping. Values range from 0-80, with higher score indicating a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Genova, Ph. D.

CONTACT

[email protected]

973-324-8390

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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