Improving Well-Being After TBI Through Structured Volunteer Activity

Traumatic Brain Injury Clinical Trial

Official title:

Improving Well-Being After TBI Through Structured Volunteer Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728350
• Other study ID #: H133A120032-1
• Status: Completed
• Phase: N/A
• First received: November 9, 2012
• Last updated: January 26, 2018
• Start date: April 2013
• Est. completion date: December 27, 2017

Study information

• Verified date: January 2018
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 27, 2017
• Est. primary completion date: December 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• HOPE - Helping Others through Purpose and Engagement

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Craig Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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