Recruiting

Well-being Interventions

Sponsor:

Kessler Foundation

Code:

NCT05943756

Conditions

TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Signature Strengths

TBI Education Course

Study Details

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)

Study ID

NCT05943756

Start date

Sep 25, 2023

Status verified date

Jan, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Rosenberg Self-Esteem Scale (RSES) [ Time Frame: Baseline, 3 months posttest, and 6 months posttest ]
  • Strengths Knowledge and Strengths Use Scale (SKUS) [ Time Frame: Baseline, 3 months posttest, and 6 months posttest ]
  • Head Injury Semantic Differential Scale - Version III (HISD-III) [ Time Frame: Baseline, 3 months posttest, and 6 months posttest ]
  • Global Assessment of Character Strengths [ Time Frame: Baseline, 3 months posttest, and 6 months posttest ]
  • Twenty-Statements Task [ Time Frame: Baseline, 3 months posttest, and 6 months posttest ]

Central Contacts and Locations

Central contacts

Helen Genova, Ph. D.

973-324-8390hgenova@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Helen M Genova, Ph.D.

hgenova@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Jan 17, 2025

Last verified

Jan, 2025

Keywords

  • TBI, Traumatic Brain Injury, Traumatic Injury, Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-01-17.