Evaluation of Well-being Interventions in Adults With TBI

NCT ID: NCT05943756

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2026-06-30

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.

Conditions

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TBI (Traumatic Brain Injury)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Both groups will participate in a different intervention program meant to improve well-being in individuals who have sustained a brain injury.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Signature Strengths

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

TBI Education Course

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helen Genova, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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Kessler Foundation

East Hanover, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Helen Genova, Ph. D.

Role: CONTACT

973-324-8390

Facility Contacts

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Helen M Genova, Ph.D.

Role: primary

Other Identifiers

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E-1220-23

Identifier Type: -

Identifier Source: org_study_id

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