Evaluation of Well-being Interventions in Adults With TBI

Sponsor
Kessler Foundation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05943756
Collaborator
(none)
94
2
35

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Signature Strengths
  • Behavioral: TBI Education Course
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Both groups will participate in a different intervention program meant to improve well-being in individuals who have sustained a brain injury.Both groups will participate in a different intervention program meant to improve well-being in individuals who have sustained a brain injury.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of Well-being Interventions in Adults With TBI
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Signature Strengths

In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury.

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.

Active Comparator: TBI Education Course

In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury.

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.

Outcome Measures

Primary Outcome Measures

  1. Rosenberg Self-Esteem Scale (RSES) [3 months]

    Self-report self-esteem questionnaire.

  2. Rosenberg Self-Esteem Scale (RSES) [6 months]

    Self-report self-esteem questionnaire.

  3. Strengths Knowledge and Strengths Use Scale (SKUS) [3 months]

    Measure to assess knowledge and use of one's strengths and measure changes following strengths-based interventions.

  4. Strengths Knowledge and Strengths Use Scale (SKUS) [6 months]

    Measure to assess knowledge and use of one's strengths and measure changes following strengths-based interventions.

  5. Head Injury Semantic Differential Scale - Version III (HISD-III) [3 months]

    Self-report for examination of past and present self-identity.

  6. Head Injury Semantic Differential Scale - Version III (HISD-III) [6 months]

    Self-report for examination of past and present self-identity.

  7. Global Assessment of Character Strengths [3 months]

    24-item questionnaire to rate levels of individual's character strengths.

  8. Global Assessment of Character Strengths [6 months]

    24-item questionnaire to rate levels of individual's character strengths.

Secondary Outcome Measures

  1. Flourishing Scale (FS) [3 months]

    Measure of well-being and "flourishing."

  2. Flourishing Scale (FS) [6 months]

    Measure of well-being and "flourishing."

  3. Quality of Life After Brain Injury (QOLIBRI) [3 months]

    Assess Quality of Life specifically in Brain Injury.

  4. Quality of Life After Brain Injury (QOLIBRI) [6 months]

    Assess Quality of Life specifically in Brain Injury.

  5. Satisfaction with Life Scale (SWLS) [3 months]

    Measure of life satisfaction.

  6. Satisfaction with Life Scale (SWLS) [6 months]

    Measure of life satisfaction.

  7. Positive and Negative Affect Schedule (PANAS) [3 months]

    Measure of both positive and negative emotional feelings.

  8. Positive and Negative Affect Schedule (PANAS) [6 months]

    Measure of both positive and negative emotional feelings.

  9. Voicemail Elicitation Task [3 months]

    Measures how individuals respond to social situations using politeness/impoliteness.

  10. Voicemail Elicitation Task [6 months]

    Measures how individuals respond to social situations using politeness/impoliteness.

  11. Perceived Stress Scale [3 months]

    10 item, Self-report measure of perceived stress

  12. Perceived Stress Scale [6 months]

    10 item, Self-report measure of perceived stress

  13. Connor-Davidson Resilience Scale 10 (CD-RISC-10) [3 months]

    10 item self-report measure of resilience

  14. Connor-Davidson Resilience Scale 10 (CD-RISC-10) [6 months]

    10 item self-report measure of resilience

  15. Brain Injury Self-Efficacy Scale [3 months]

    20 item self-report measure of self-efficacy and coping

  16. Brain Injury Self-Efficacy Scale [6 months]

    20 item self-report measure of self-efficacy and coping

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kessler Foundation

Investigators

  • Principal Investigator: Helen Genova, Ph. D., Kessler Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT05943756
Other Study ID Numbers:
  • E-1220-23
First Posted:
Jul 13, 2023
Last Update Posted:
Jul 13, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kessler Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2023