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Well-being Interventions for Traumatic Brain Injury

N/A

Recruiting

Led By Helen Genova, Ph. D.

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months posttest, and 6 months posttest

Awards & highlights

Study Summary

This trial looks at how two programs can help adults with TBI improve their overall health & wellbeing.

Who is the study for?

Adults over 18 with moderate to severe traumatic brain injury (TBI) at least one year post-injury, who can speak and read English fluently. Excludes those with multiple sclerosis, stroke history, seizures, significant psychiatric illnesses like schizophrenia or psychosis, current steroid/benzodiazepine use, substance abuse requiring inpatient treatment, or prior Signature Strengths program participation.Check my eligibility

What is being tested?

The trial is testing two programs aimed at improving well-being in adults with TBI: an educational course on TBI and a program focused on leveraging personal 'Signature Strengths'. The effectiveness of these interventions will be measured over time.See study design

What are the potential side effects?

Since the interventions are non-medical (education and strengths-based programs), traditional side effects associated with medications are not expected. However, participants may experience varying psychological impacts based on their individual responses to the intervention content.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months posttest, and 6 months posttest

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months posttest, and 6 months posttest

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months posttest, and 6 months posttest for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Global Assessment of Character Strengths

Head Injury Semantic Differential Scale - Version III (HISD-III)

Rosenberg Self-Esteem Scale (RSES)

+2 more

Secondary outcome measures

Brain Injury Self-Efficacy Scale

Connor-Davidson Resilience Scale 10 (CD-RISC-10)

Flourishing Scale (FS)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Signature StrengthsExperimental Treatment1 Intervention

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 II: TBI Education CourseActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor

174 Previous Clinical Trials

10,644 Total Patients Enrolled

Helen Genova, Ph. D.Principal InvestigatorKessler Foundation

2 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are partaking in this research endeavor?

"Affirmative. The clinical trial's page on clinicaltrials.gov indicates that they are actively recruiting patients, with 94 participants needed at a single site since it was first posted in September 25th and last updated October 24th of 2023."

Answered by AI

Does this experiment currently have any openings for participants?

"Affirmative. According to the information provided on clinicaltrials.gov, this medical trial has been opened for recruitment since September 25th 2023 and was last updated October 24th of that same year. A total of 94 participants are being sought from 1 site."

Answered by AI

What are the main goals of this experimental research?

"This clinical trial, to be monitored over a Baseline assessment period and at 3-month and 6-month posttest intervals, has Global Assessment of Character Strengths as its primary goal. Its secondary objectives are the Voicemail Elicitation Task (which measures politeness/impoliteness responses in social situations through markers divided by total minutes), Perceived Stress Scale (a self-report measure with values ranging from 0 - 40; higher scores indicating worse outcomes) ,and Brain injury Self-Efficacy Scale(20 items measuring self-efficacy & coping, yielding values between 0 - 80; higher scores depicting better results"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Well-being Interventions in Adults With TBI

2023. "Evaluation of Well-being Interventions in Adults With TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05943756.