Back to resultsEvaluation of Well-being Interventions in Adults With TBI
Primary Purpose
TBI (Traumatic Brain Injury)
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Signature Strengths
TBI Education Course
Sponsored by
About this trial
This is an interventional treatment trial for TBI (Traumatic Brain Injury) focused on measuring TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Signature Strengths
TBI Education Course
Arm Description
In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury.
In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury.
Outcomes
Primary Outcome Measures
Rosenberg Self-Esteem Scale (RSES)
Self-report self-esteem questionnaire.
Rosenberg Self-Esteem Scale (RSES)
Self-report self-esteem questionnaire.
Strengths Knowledge and Strengths Use Scale (SKUS)
Measure to assess knowledge and use of one's strengths and measure changes following strengths-based interventions.
Strengths Knowledge and Strengths Use Scale (SKUS)
Measure to assess knowledge and use of one's strengths and measure changes following strengths-based interventions.
Head Injury Semantic Differential Scale - Version III (HISD-III)
Self-report for examination of past and present self-identity.
Head Injury Semantic Differential Scale - Version III (HISD-III)
Self-report for examination of past and present self-identity.
Global Assessment of Character Strengths
24-item questionnaire to rate levels of individual's character strengths.
Global Assessment of Character Strengths
24-item questionnaire to rate levels of individual's character strengths.
Secondary Outcome Measures
Flourishing Scale (FS)
Measure of well-being and "flourishing."
Flourishing Scale (FS)
Measure of well-being and "flourishing."
Quality of Life After Brain Injury (QOLIBRI)
Assess Quality of Life specifically in Brain Injury.
Quality of Life After Brain Injury (QOLIBRI)
Assess Quality of Life specifically in Brain Injury.
Satisfaction with Life Scale (SWLS)
Measure of life satisfaction.
Satisfaction with Life Scale (SWLS)
Measure of life satisfaction.
Positive and Negative Affect Schedule (PANAS)
Measure of both positive and negative emotional feelings.
Positive and Negative Affect Schedule (PANAS)
Measure of both positive and negative emotional feelings.
Voicemail Elicitation Task
Measures how individuals respond to social situations using politeness/impoliteness.
Voicemail Elicitation Task
Measures how individuals respond to social situations using politeness/impoliteness.
Perceived Stress Scale
10 item, Self-report measure of perceived stress
Perceived Stress Scale
10 item, Self-report measure of perceived stress
Connor-Davidson Resilience Scale 10 (CD-RISC-10)
10 item self-report measure of resilience
Connor-Davidson Resilience Scale 10 (CD-RISC-10)
10 item self-report measure of resilience
Brain Injury Self-Efficacy Scale
20 item self-report measure of self-efficacy and coping
Brain Injury Self-Efficacy Scale
20 item self-report measure of self-efficacy and coping
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05943756
Brief Title
Evaluation of Well-being Interventions in Adults With TBI
Official Title
Evaluation of Well-being Interventions in Adults With TBI
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)
Keywords
TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Signature Strengths
Arm Type
Experimental
Arm Description
In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury.
Arm Title
TBI Education Course
Arm Type
Active Comparator
Arm Description
In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury.
Intervention Type
Behavioral
Intervention Name(s)
Signature Strengths
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TBI Education Course
Intervention Description
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 Measure Information:
Title
Rosenberg Self-Esteem Scale (RSES)
Description
Self-report self-esteem questionnaire.
Time Frame
3 months
Title
Rosenberg Self-Esteem Scale (RSES)
Description
Self-report self-esteem questionnaire.
Time Frame
6 months
Title
Strengths Knowledge and Strengths Use Scale (SKUS)
Description
Measure to assess knowledge and use of one's strengths and measure changes following strengths-based interventions.
Time Frame
3 months
Title
Strengths Knowledge and Strengths Use Scale (SKUS)
Description
Measure to assess knowledge and use of one's strengths and measure changes following strengths-based interventions.
Time Frame
6 months
Title
Head Injury Semantic Differential Scale - Version III (HISD-III)
Description
Self-report for examination of past and present self-identity.
Time Frame
3 months
Title
Head Injury Semantic Differential Scale - Version III (HISD-III)
Description
Self-report for examination of past and present self-identity.
Time Frame
6 months
Title
Global Assessment of Character Strengths
Description
24-item questionnaire to rate levels of individual's character strengths.
Time Frame
3 months
Title
Global Assessment of Character Strengths
Description
24-item questionnaire to rate levels of individual's character strengths.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Flourishing Scale (FS)
Description
Measure of well-being and "flourishing."
Time Frame
3 months
Title
Flourishing Scale (FS)
Description
Measure of well-being and "flourishing."
Time Frame
6 months
Title
Quality of Life After Brain Injury (QOLIBRI)
Description
Assess Quality of Life specifically in Brain Injury.
Time Frame
3 months
Title
Quality of Life After Brain Injury (QOLIBRI)
Description
Assess Quality of Life specifically in Brain Injury.
Time Frame
6 months
Title
Satisfaction with Life Scale (SWLS)
Description
Measure of life satisfaction.
Time Frame
3 months
Title
Satisfaction with Life Scale (SWLS)
Description
Measure of life satisfaction.
Time Frame
6 months
Title
Positive and Negative Affect Schedule (PANAS)
Description
Measure of both positive and negative emotional feelings.
Time Frame
3 months
Title
Positive and Negative Affect Schedule (PANAS)
Description
Measure of both positive and negative emotional feelings.
Time Frame
6 months
Title
Voicemail Elicitation Task
Description
Measures how individuals respond to social situations using politeness/impoliteness.
Time Frame
3 months
Title
Voicemail Elicitation Task
Description
Measures how individuals respond to social situations using politeness/impoliteness.
Time Frame
6 months
Title
Perceived Stress Scale
Description
10 item, Self-report measure of perceived stress
Time Frame
3 months
Title
Perceived Stress Scale
Description
10 item, Self-report measure of perceived stress
Time Frame
6 months
Title
Connor-Davidson Resilience Scale 10 (CD-RISC-10)
Description
10 item self-report measure of resilience
Time Frame
3 months
Title
Connor-Davidson Resilience Scale 10 (CD-RISC-10)
Description
10 item self-report measure of resilience
Time Frame
6 months
Title
Brain Injury Self-Efficacy Scale
Description
20 item self-report measure of self-efficacy and coping
Time Frame
3 months
Title
Brain Injury Self-Efficacy Scale
Description
20 item self-report measure of self-efficacy and coping
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Genova, Ph. D.
Phone
973-324-8390
Email
hgenova@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Genova, Ph. D.
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Well-being Interventions in Adults With TBI
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