<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01728350</url>
  </required_header>
  <id_info>
    <org_study_id>H133A120032-1</org_study_id>
    <nct_id>NCT01728350</nct_id>
  </id_info>
  <brief_title>Improving Well-Being After TBI Through Structured Volunteer Activity</brief_title>
  <official_title>Improving Well-Being After TBI Through Structured Volunteer Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Craig Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Craig Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to determine if participating in volunteer activity improves&#xD;
      the psychological well-being of individuals with traumatic brain injury (TBI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">December 27, 2017</completion_date>
  <primary_completion_date type="Actual">December 27, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.</measure>
    <time_frame>Baseline, post-intervention, 3 mos f/u, 6 mos f/u</time_frame>
    <description>A five-item, self-rated scale of global life satisfaction. Items are rated on 1-7 point Likert scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.</measure>
    <time_frame>Baseline, post-intervetion, 3mos f/u, 6mos f/u</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points.</measure>
    <time_frame>Baseline, post-intervention, 3mos f/u, 6mos f/u</time_frame>
    <description>An 18-item, self-rated measure of psychological distress. Items are rated on 0-4 Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points.</measure>
    <time_frame>Baseline, post-intervention, 3mos f/u, 6mos f/u</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points.</measure>
    <time_frame>Baseline, post-intervention, 3mos f/u, 6mos f/u</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline on Hair Cortisol test at post-intervention and at follow-up points.</measure>
    <time_frame>Baseline, post-intervention, 3mos f/u, 6 mos f/u</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants who are randomized to the control arm will be offered the HOPE intervention at the conclusion of study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HOPE - Helping Others through Purpose and Engagement</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>HOPE - Helping Other through Purpose and Engagement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has sustained a documented TBI that required inpatient rehabilitation;&#xD;
&#xD;
          -  is at least one year post TBI;&#xD;
&#xD;
          -  is age 18 or older;&#xD;
&#xD;
          -  is able to commit to completing the entire three month volunteer placement;&#xD;
&#xD;
          -  is English or Spanish speaking;&#xD;
&#xD;
          -  receives written medical release from a physician to participate in this intervention;&#xD;
&#xD;
          -  is rated a level 1-2 on the Supervision Rating Scale (functionally independent during&#xD;
             the day);&#xD;
&#xD;
          -  provides informed consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is employed or engaged in regularly scheduled volunteer work outside of the&#xD;
             intervention;&#xD;
&#xD;
          -  obtains a score of 25 or above on the SWLS, which is 0.5 SD above the TBIMS NDB mean;&#xD;
&#xD;
          -  unable to travel to assessments and placement; even with study transportation&#xD;
             assistance;&#xD;
&#xD;
          -  has been convicted of a felony, which would prohibit volunteer placement;&#xD;
&#xD;
          -  unable to communicate effectively to complete standardized assessments;&#xD;
&#xD;
          -  has cognitive impairment that precludes completion of baseline testing;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lenore Hawley, LCSW</last_name>
    <role>Principal Investigator</role>
    <affiliation>Craig Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Payne, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Craig Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Craig Hospital</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>January 26, 2018</last_update_submitted>
  <last_update_submitted_qc>January 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>traumatic brain injury</keyword>
  <keyword>volunteering</keyword>
  <keyword>well being</keyword>
  <keyword>cortisol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01728350
org study id: H133A120032-1
nct id: NCT01728350
lead sponsor: 
has dmc: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.
time frame: Baseline, post-intervention, 3 mos f/u, 6 mos f/u
description: A five-item, self-rated scale of global life satisfaction. Items are rated on 1-7 point Likert scale.
measure: Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.
time frame: Baseline, post-intervetion, 3mos f/u, 6mos f/u
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.
measure: Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points.
time frame: Baseline, post-intervention, 3mos f/u, 6mos f/u
description: An 18-item, self-rated measure of psychological distress. Items are rated on 0-4 Likert scale.
measure: Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points.
time frame: Baseline, post-intervention, 3mos f/u, 6mos f/u
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.
measure: Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points.
time frame: Baseline, post-intervention, 3mos f/u, 6mos f/u
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.
measure: Change from baseline on Hair Cortisol test at post-intervention and at follow-up points.
time frame: Baseline, post-intervention, 3mos f/u, 6 mos f/u
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.
arm group label: Treatment
arm group type: Experimental
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 group label: Control
arm group type: No Intervention
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: HOPE - Helping Others through Purpose and Engagement
arm group label: Treatment
other name: HOPE - Helping Other through Purpose and Engagement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lenore Hawley, LCSW
role: Principal Investigator
affiliation: Craig Hospital
last name: Lisa Payne, PhD
role: Principal Investigator
affiliation: Craig Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic