Evaluation of Well-being Interventions in Adults With TBI

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

Evaluation of Well-being Interventions in Adults With TBI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943756
• Other study ID #: E-1220-23
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Kessler Foundation
• Contact: Helen Genova, Ph. D.
• Phone: 973-324-8390
• Email: hgenova[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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