Evaluation of Well-being Interventions in Adults With TBI

NCT05943756 | Recruiting

• 1 other identifier: E-1220-23
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Flourishing Scale (FS)

  Baseline, 3 months posttest, and 6 months posttest

• Quality of Life After Brain Injury (QOLIBRI)

  Baseline, 3 months posttest, and 6 months posttest

• Satisfaction with Life Scale (SWLS)

  Baseline, 3 months posttest, and 6 months posttest

• Positive and Negative Affect Schedule (PANAS)

  Baseline, 3 months posttest, and 6 months posttest

• Voicemail Elicitation Task

  Baseline, 3 months posttest, and 6 months posttest

Study Arms (2)

Signature Strengths

EXPERIMENTAL

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

TBI Education Course

ACTIVE COMPARATOR

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

Interventions

Signature Strengths BEHAVIORAL

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.

Signature Strengths

TBI Education Course BEHAVIORAL

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.

TBI Education Course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Helen Genova, Ph. D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Genova, Ph. D.

CONTACT

973-324-8390; hgenova@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both groups will participate in a different intervention program meant to improve well-being in individuals who have sustained a brain injury.

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: September 25, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)