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Improving Well-Being After TBI Through Structured Volunteer Activity

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HOPE - Helping Others through Purpose and Engagement
Sponsored by
Craig Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, volunteering, well being, cortisol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Craig Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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.

Participants who are randomized to the control arm will be offered the HOPE intervention at the conclusion of study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 9, 2012
Last Updated
January 26, 2018
Sponsor
Craig Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01728350
Brief Title
Improving Well-Being After TBI Through Structured Volunteer Activity
Official Title
Improving Well-Being After TBI Through Structured Volunteer Activity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 27, 2017 (Actual)
Study Completion Date
December 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Craig Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, volunteering, well being, cortisol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants who are randomized to the control arm will be offered the HOPE intervention at the conclusion of study.
Intervention Type
Behavioral
Intervention Name(s)
HOPE - Helping Others through Purpose and Engagement
Other Intervention Name(s)
HOPE - Helping Other through Purpose and Engagement
Primary Outcome Measure Information:
Title
Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.
Description
A five-item, self-rated scale of global life satisfaction. Items are rated on 1-7 point Likert scale.
Time Frame
Baseline, post-intervention, 3 mos f/u, 6 mos f/u
Secondary Outcome Measure Information:
Title
Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.
Description
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.
Time Frame
Baseline, post-intervetion, 3mos f/u, 6mos f/u
Title
Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points.
Description
An 18-item, self-rated measure of psychological distress. Items are rated on 0-4 Likert scale.
Time Frame
Baseline, post-intervention, 3mos f/u, 6mos f/u
Title
Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points.
Description
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.
Time Frame
Baseline, post-intervention, 3mos f/u, 6mos f/u
Title
Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points.
Description
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.
Time Frame
Baseline, post-intervention, 3mos f/u, 6mos f/u
Other Pre-specified Outcome Measures:
Title
Change from baseline on Hair Cortisol test at post-intervention and at follow-up points.
Description
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.
Time Frame
Baseline, post-intervention, 3mos f/u, 6 mos f/u

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lenore Hawley, LCSW
Organizational Affiliation
Craig Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Payne, PhD
Organizational Affiliation
Craig Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States

12. IPD Sharing Statement

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Improving Well-Being After TBI Through Structured Volunteer Activity

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