Improving Well-Being After TBI Through Structured Volunteer Activity

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).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: HOPE - Helping Others through Purpose and Engagement

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Craig Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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; Other Names: HOPE - Helping Other through Purpose and Engagement
No Intervention: Control; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on Hair Cortisol test at post-intervention and at follow-up points.	This 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.	Baseline, post-intervention, 3mos f/u, 6 mos f/u

Collaborators and Investigators

• Sponsor: Craig Hospital
• Investigators: Principal Investigator: Lenore Hawley, LCSW, Craig Hospital; Principal Investigator: Lisa Payne, PhD, Craig Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 27, 2017
• Study Completion (Actual): December 27, 2017

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 19, 2012

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: traumatic brain injury; cortisol; well being; volunteering
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: H133A120032-1