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Improving Well-Being After TBI Through Structured Volunteer Activity

Improving Well-Being After TBI Through Structured Volunteer Activity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01728350
Enrollment
74
Registered
2012-11-19
Start date
2013-04-30
Completion date
2017-12-27
Last updated
2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, volunteering, well being, cortisol

Brief summary

The purpose of this project is to determine if participating in volunteer activity improves the psychological well-being of individuals with traumatic brain injury (TBI).

Interventions

BEHAVIORALHOPE - Helping Others through Purpose and Engagement

Sponsors

Craig Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Has sustained a documented TBI that required inpatient rehabilitation; * is at least one year post TBI; * is age 18 or older; * is able to commit to completing the entire three month volunteer placement; * is English or Spanish speaking; * receives written medical release from a physician to participate in this intervention; * is rated a level 1-2 on the Supervision Rating Scale (functionally independent during the day); * provides informed consent to participate

Exclusion criteria

* Is employed or engaged in regularly scheduled volunteer work outside of the intervention; * obtains a score of 25 or above on the SWLS, which is 0.5 SD above the TBIMS NDB mean; * unable to travel to assessments and placement; even with study transportation assistance; * has been convicted of a felony, which would prohibit volunteer placement; * unable to communicate effectively to complete standardized assessments; * has cognitive impairment that precludes completion of baseline testing;

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.Baseline, post-intervention, 3 mos f/u, 6 mos f/uA five-item, self-rated scale of global life satisfaction. Items are rated on 1-7 point Likert scale.

Secondary

MeasureTime frameDescription
Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.Baseline, post-intervetion, 3mos f/u, 6mos f/uAn 8-item self-rated scale of perceived success in areas such as social relationships, self-esteem, and purpose in life. Items are rated on 1-7 point Likert scale.
Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points.Baseline, post-intervention, 3mos f/u, 6mos f/uAn 18-item, self-rated measure of psychological distress. Items are rated on 0-4 Likert scale.
Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points.Baseline, post-intervention, 3mos f/u, 6mos f/uA 12-item, self-rated scale that evaluates positive and negative emotions. It produces a score of positive and negative feelings that can be combined to create a balance score.
Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points.Baseline, post-intervention, 3mos f/u, 6mos f/uConsists of nine, self-rated items regarding individual goals, sense of direction, and meaning. This subscale was selected because volunteering has been shown to have a positive relationship with a sense of purpose in life.

Other

MeasureTime frameDescription
Change from baseline on Hair Cortisol test at post-intervention and at follow-up points.Baseline, post-intervention, 3mos f/u, 6 mos f/uThis is considered an Exploratory Measure. Cortisol has been explored as a potential biomarker of well-being; lower levels of salivary cortisol have been associated with higher levels of psychological well-being. Recently, reliable and valid methods for measuring long-term cortisol secretion through hair samples have been developed and are being used as biomarkers of chronic stress in multiple medical conditions.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026