Clinical trial NCT01728350: Improving Well-Being After TBI Through Structured Volunteer Activity
Official title: Improving Well-Being After TBI Through Structured Volunteer Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
volunteering
well being
cortisol
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2012-11-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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;

Primary outcomes:
measure: Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.
timeFrame: Baseline, post-intervention, 3 mos f/u, 6 mos f/u
Secondary outcomes:
measure: Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.
timeFrame: Baseline, post-intervetion, 3mos f/u, 6mos f/u
measure: Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points.
timeFrame: Baseline, post-intervention, 3mos f/u, 6mos f/u
measure: Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points.
timeFrame: Baseline, post-intervention, 3mos f/u, 6mos f/u
measure: Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points.
timeFrame: Baseline, post-intervention, 3mos f/u, 6mos f/u
Other outcomes:
measure: Change from baseline on Hair Cortisol test at post-intervention and at follow-up points.
timeFrame: Baseline, post-intervention, 3mos f/u, 6 mos f/u
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
affiliation: Craig Hospital
name: Lenore Hawley, LCSW
role: PRINCIPAL_INVESTIGATOR
affiliation: Craig Hospital
name: Lisa Payne, PhD
role: PRINCIPAL_INVESTIGATOR
References: