Improving Well-Being After TBI Through Structured Volunteer Activity

Study Overview
=================
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).

Official Title
-----------------
Improving Well-Being After TBI Through Structured Volunteer Activity

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Behavioral: HOPE - Helping Others through Purpose and Engagement


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Participants in this arm will participate in a novel structured volunteering intervention called HOPE - Helping Others through Purpose and Engagement. This intervention involves orientation, training, volunteer placement assistance, and problem solving and support. | Behavioral: HOPE - Helping Others through Purpose and Engagement<br> <br> * Other names: HOPE - Helping Other through Purpose and Engagement;|
| No Intervention: Control<br>Participants who are randomized to the control arm will be offered the HOPE intervention at the conclusion of study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on Flourishing Scale at post-intervention, and at follow-up points. | An 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. | Baseline, post-intervetion, 3mos f/u, 6mos f/u | 
| Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points. | An 18-item, self-rated measure of psychological distress. Items are rated on 0-4 Likert scale. | Baseline, post-intervention, 3mos f/u, 6mos f/u | 
| Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points. | A 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. | Baseline, post-intervention, 3mos f/u, 6mos f/u | 
| Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points. | Consists 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. | Baseline, post-intervention, 3mos f/u, 6mos f/u | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic brain injury, volunteering, well being, cortisol