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.

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Behavioral: Signature Strengths; Behavioral: TBI Education Course

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 Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Genova, Ph. D.; Phone Number: 973-324-8390; Email: hgenova@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Recruiting
      • Kessler Foundation
      • Contact: Helen M Genova, Ph.D.; Email: hgenova@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries
• Other Study ID Numbers: E-1220-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No