Improving Well-Being After TBI Through Structured Volunteer Activity

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: HOPE - Helping Others through Purpose and Engagement

• Registration Number: NCT01728350
• Lead Sponsor: Craig Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-19
• Study Start: 2013-04
• Primary Completion: 2017-12-27
• Study Completion: 2017-12-27
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	HOPE - Helping Others through Purpose and Engagement	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.

Primary Outcome Measures

Name	Time	Method
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/u	A five-item, self-rated scale of global life satisfaction. Items are rated on 1-7 point Likert scale.

Secondary Outcome Measures

Name	Time	Method
Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.	Baseline, post-intervetion, 3mos f/u, 6mos f/u	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.
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/u	An 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/u	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.
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/u	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.

Trial Locations

Locations (1)

Craig Hospital; 🇺🇸 Englewood, Colorado, United States