Evaluation of Well-being Interventions in Adults With TBI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Well-being Interventions in Adults With TBI

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Behavioral: Signature Strengths
* Behavioral: TBI Education Course


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Signature Strengths<br>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<br>* 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.<br>|
| Active Comparator: TBI Education Course<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rosenberg Self-Esteem Scale (RSES) | Self-report self-esteem questionnaire. Values range from 10-40, with higher score indicating better outcome. | 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. | 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. | 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. | 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. | Baseline, 3 months posttest, and 6 months posttest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flourishing Scale (FS) | Measure of well-being and flourishing. Values range from 8-56, with higher score indicating a better outcome. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 3 months posttest, and 6 months posttest | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury