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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Signature Strengths, VIA Survey of Character Strengths, Values in Action Survey, Character Strengths Intervention, TBI Education Course for traumatic brain injury?

Research shows that character strengths-based interventions can improve psychological well-being in patients with chronic illnesses, suggesting potential benefits for those with traumatic brain injury. Additionally, some studies indicate that rehabilitation can positively impact self-concept in TBI patients, which may be enhanced by focusing on character strengths. ^{1 2 3 4 5}

Is the well-being intervention for traumatic brain injury safe for humans?

The research does not provide specific safety data for the well-being interventions, but it suggests that positive psychological traits like resilience and optimism are associated with better recovery outcomes in traumatic brain injury patients, indicating these interventions are generally safe and beneficial. ^{1 5 6 7 8}

How does this treatment for traumatic brain injury differ from other treatments?

This treatment focuses on using positive psychology interventions, which aim to enhance traits like hope, optimism, and resilience to improve recovery from traumatic brain injury. Unlike traditional treatments that may focus on physical rehabilitation, this approach targets psychological well-being to help patients adjust and improve their mood and self-concept. ^{1 5 7 9 10}

Research Team

Helen Genova, Ph. D.

Principal Investigator

Kessler Foundation

Eligibility Criteria

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 am 18 years old or older.

Able to speak and read English fluently

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

Exclusion Criteria

Have a significant psychiatric illness (like schizophrenia or psychosis)

I am currently taking steroids or benzodiazepines.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Role of character strengths in outcome after mild complicated to severe traumatic brain injury: a positive psychology study. [2019]

2. England 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Spain pubmed.ncbi.nlm.nih.gov

[What happens after the accident? Psychosocial needs of people with traumatic brain injury and their families]. [2020]

5. England 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. [2021]

6. United States 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Positive psychology perspective on traumatic brain injury recovery and rehabilitation. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Resilience Is Associated with Outcome from Mild Traumatic Brain Injury. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Exploring the use of positive psychology interventions in brain injury survivors with challenging behaviour. [2022]

10. England 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). [2022]