Well-being Interventions for Traumatic Brain Injury

Overseen By Helen Genova, Ph. D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Steroids, Benzodiazepines

Disqualifiers: Multiple sclerosis, Stroke, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two programs designed to enhance well-being in adults with traumatic brain injury (TBI). One program, Signature Strengths (also known as the VIA Survey of Character Strengths or Values in Action Survey), focuses on utilizing personal strengths. The other is an educational course about TBI. The trial aims to determine if these programs can produce lasting positive effects. Individuals who have experienced a moderate to severe brain injury for at least a year and can read and speak English fluently might be suitable candidates. As an unphased trial, this study offers a unique opportunity to advance understanding and improve TBI recovery strategies.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking steroids or benzodiazepines.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Signature Strengths program helps individuals identify and use their personal strengths to enhance well-being. Studies have found these activities are generally well-received and safe for most people, with no evidence of serious side effects.

Similarly, the TBI Education Course builds on educational programs that are commonly used and considered safe. These programs aim to inform and support individuals, with no known significant risks.

In summary, available research indicates that both the Signature Strengths program and the TBI Education Course are safe options. Participants can expect these programs to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on enhancing well-being for individuals with traumatic brain injury (TBI), which is a unique approach compared to traditional methods that often emphasize medical or physical rehabilitation. The Signature Strengths intervention leverages individuals' personal strengths to improve mental and emotional health, offering a more personalized and positive angle. Meanwhile, the TBI Education Course empowers participants with knowledge about their condition, promoting self-awareness and proactive management. Both treatments aim to improve quality of life, which is a refreshing shift from conventional TBI treatments that primarily focus on physical recovery.

What evidence suggests that this trial's interventions could be effective for improving well-being in individuals with traumatic brain injury?

Research shows that using unique strengths can boost well-being and mental health. Studies on personal strengths have found that focusing on these traits helps people feel more confident and happier. This method also builds resilience, enabling recovery from difficulties. In this trial, participants in the Signature Strengths arm will engage in an intervention program designed to improve well-being in individuals who have sustained a brain injury. For those with a traumatic brain injury (TBI), these strengths can aid in recovery and improve social interactions. Overall, evidence suggests that recognizing and using unique strengths can lead to better outcomes after a TBI. ^{2 3 4 6 7}

Who Is on the Research Team?

Helen Genova, Ph. D.

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with a moderate to severe traumatic brain injury.

Able to speak and read English fluently

It has been over a year since my injury.

Exclusion Criteria

Have a significant psychiatric illness (like schizophrenia or psychosis)

I have a history of neurological conditions such as multiple sclerosis, stroke, seizures, or similar.

I am currently taking steroids or benzodiazepines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either the Signature Strengths intervention or the TBI Education Course to improve well-being

12 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for well-being and self-concept outcomes post-intervention

6 months

Assessments at 3 months and 6 months posttest

What Are the Treatments Tested in This Trial?

Interventions

• Signature Strengths
• TBI Education Course

Trial Overview 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.

How Is the Trial Designed?

Group I: Signature Strengths Experimental Treatment 1 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 Course Active Control 1 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.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

The VaLiANT group intervention, designed to enhance 'valued living' after acquired brain injury (ABI), was found to be feasible and well-accepted by participants, indicating it can be effectively delivered in a group setting.

While the primary target behavior of valued living did not show significant improvement, many participants reported reliable enhancements in secondary outcomes such as subjective wellbeing and anxiety, suggesting potential benefits of the intervention in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-case experimental evaluation of a new group-based intervention to enhance adjustment to life with acquired brain injury: VaLiANT (valued living after neurological trauma). Sathananthan, N., Dimech-Betancourt, B., Morris, E., et al.[2022]

In a study of 74 patients with mild traumatic brain injury (mTBI), those with moderate-to-high resilience reported significantly fewer post-concussion symptoms and better quality of life compared to those with low resilience.

The Resilience Scale and its short form were found to be reliable tools for evaluating resilience in mTBI patients, with high internal consistency and test-retest reliability, indicating they can be effectively used in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resilience Is Associated with Outcome from Mild Traumatic Brain Injury. Losoi, H., Silverberg, ND., Wäljas, M., et al.[2022]

Self-reported traits such as the number of postconcussive symptoms, fatigue, and physical competence are likely predictive of employment outcomes for individuals with traumatic brain injury (TBI), based on a systematic review of 63 studies.

Environmental factors like access to transportation and services, as well as social interaction, may also influence employment outcomes, while factors like living arrangements and social support showed less predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic importance of self-reported traits/problems/strengths and environmental barriers/facilitators for predicting participation outcomes in persons with traumatic brain injury: a systematic review. Sherer, M., Davis, LC., Sander, AM., et al.[2018]

Recovery from traumatic brain injury (TBI) varies widely, and while injury characteristics play a role, psychological factors like positive affect and resilience are crucial for better psychosocial outcomes.

Research indicates that enhancing positive psychological traits, such as optimism and adaptive coping skills, may improve recovery from TBI, with some early trials showing promising results in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive psychology perspective on traumatic brain injury recovery and rehabilitation. Rabinowitz, AR., Arnett, PA.[2018]

A systematic review of eight studies involving 692 patients found that character strengths-based interventions effectively improved self-esteem, general self-efficacy, and reduced depression in individuals with chronic illnesses.

While the results support the positive impact of these interventions on psychological well-being, the limited number of studies and variability among them suggest that more research is needed to confirm these findings and enhance their application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effects of character strengths-based intervention on the psychological well-being of patients suffering from chronic illnesses. Yan, T., Chan, CWH., Chow, KM., et al.[2021]

In a study of 65 individuals with mild to severe traumatic brain injury (TBI), character strengths and virtues were found to be moderately associated with positive psychosocial outcomes, such as greater life satisfaction and perceived community integration.

While character strengths showed less impact on objective health measures, they were valuable in predicting physical health and disability, suggesting that enhancing these strengths in TBI patients could lead to improved subjective well-being and potentially lower comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of character strengths in outcome after mild complicated to severe traumatic brain injury: a positive psychology study. Hanks, RA., Rapport, LJ., Waldron-Perrine, B., et al.[2019]

The study involved 10 patients with traumatic brain injury (TBI) and tested two positive psychology interventions, showing an increase in happiness for the intervention group compared to baseline, although the long-term effects were not statistically significant.

Anecdotal evidence suggested improved mood following the interventions, indicating that positive psychology methods may be feasible and beneficial for enhancing emotional well-being in TBI survivors within a neuro-rehabilitation hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the use of positive psychology interventions in brain injury survivors with challenging behaviour. Andrewes, HE., Walker, V., O'Neill, B.[2022]

The study involved 49 participants with traumatic brain injury (TBI) and identified a central theme of losing a sense of integrated self-identity, highlighting the importance of self-perception in recovery after TBI.

Three key aspects of self-identity were identified: the need for a coherent sense of self, validation from others, and having a valued role in society, which will inform the development of a quantitative tool to measure self-identity in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a person-centred framework of self-identity after traumatic brain injury: a grounded theory study to inform measure development. Levack, WM., Boland, P., Taylor, WJ., et al.[2021]

This review analyzed 17 studies on the impact of various interventions (like psychotherapy and cognitive rehabilitation) on self-concept in adults with traumatic brain injury (TBI), revealing mixed results in efficacy, with only 10 studies showing improvements.

The findings emphasize the importance of addressing self-concept in TBI rehabilitation, suggesting that current methodologies need to improve to better assess and enhance individuals' sense of self during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of rehabilitation on self-concept following traumatic brain injury: An exploratory systematic review of intervention methodology and efficacy. Ownsworth, T., Haslam, C.[2018]

A study involving 37 participants, including 14 individuals with traumatic brain injury and 23 caregivers, identified five key factors that enhance quality of life: informal support from family and friends, formal support services, clinical characteristics, social participation, and social visibility.

The findings emphasize the importance of social and emotional support for individuals with severe traumatic brain injury, suggesting that effective care should extend beyond medical treatment to include tailored social and psychological support for both patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What happens after the accident? Psychosocial needs of people with traumatic brain injury and their families]. Gifre, M., Gil, Á., Pla, L., et al.[2020]

Citations

1. viacharacter.org viacharacter.org/

VIA Character Strengths Survey & Character Reports Take the Free Strengths Survey to begin living your best life. Research shows that applying your strengths can increase confidence, happiness, positive ...

2. viacharacter.org viacharacter.org/research/findings/signature-strengths

Signature Strengths Research & Insights | VIA Institute Explore key research on signature strengths—core character traits associated with human flourishing, resilience, and optimal mental well-being.

3. viacharacter.org viacharacter.org/researchers/assessments/signature-strengths-survey

Signature Strengths Survey | VIA Institute The Signature Strengths Survey (SSS) directly measures signature strengths by having users identify those strengths that are absolutely essential to you.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999314004742

Role of Character Strengths in Outcome After Mild ... Abstract. Objective. To examine the effects of character strengths on psychosocial outcomes after mild complicated to severe traumatic brain injury (TBI).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7873298/

The Practice of Character Strengths: Unifying Definitions ... Explore and Encourage Signature Strengths. Signature strengths are those character strengths highest in an individual's VIA Survey results ...

6. viacharacter.org viacharacter.org/pdf/Signature_Strengths_Survey.pdf

Signature Strengths Survey Read the following descriptions of 24 character strengths. Everyone uses these strengths at times. What we would like you to do is to put a check in the box ...

7. ppc.sas.upenn.edu ppc.sas.upenn.edu/resources/questionnaires-researchers/survey-character-strengths

VIA Survey of Character Strengths | Positive Psychology Center The Values in Action (VIA) Survey of Character Strengths is a 240-item face-valid self-report questionnaire intended for use with adults.