Evaluation of Well-being Interventions in Adults With TBI

Kessler Foundation

Status: Enrolling

Conditions: TBI (Traumatic Brain Injury)

Treatments: Behavioral: Signature Strengths; Behavioral: TBI Education Course

Study type: Interventional

Funder types: Other

Identifiers

NCT05943756

E-1220-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

94 participants in 2 patient groups

Signature Strengths

Experimental group

Description:

In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury.

Treatment:

Behavioral: Signature Strengths

TBI Education Course

Active Comparator group

Description:

In this arm, participants would participate in in an intervention program meant to improve well-being in individuals who have sustained a brain injury.

Treatment:

Behavioral: TBI Education Course