<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/NCT03816215</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00053435</org_study_id>
    <nct_id>NCT03816215</nct_id>
  </id_info>
  <brief_title>Volunteering as an Intervention to Reduce Depression Among Adolescents</brief_title>
  <official_title>Volunteering as an Intervention to Reduce Depression Among Adolescents: Investigating Neurobiological Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to test in a preliminary manner an innovative strategy&#xD;
      for treating depression among adolescents (alongside existing therapy) using community&#xD;
      volunteerism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the present study is to test in a preliminary manner an innovative strategy&#xD;
      for treating depression among adolescents (alongside existing therapy) using community&#xD;
      volunteerism. In addition, this study will test a potential mechanism by which volunteering&#xD;
      might decrease depressive symptoms: increasing psychosocial assets, specifically decreasing&#xD;
      self-orientation and increasing an orientation toward others. This will be measured through&#xD;
      self-report as well as using functional magnetic resonance imaging (fMRI). This study will be&#xD;
      the first study to explore how neural response patterns are potentially altered by intense&#xD;
      experiences with volunteerism among depressed adolescents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2019</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant recruitment</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants screened (reported by clinical mental health providers)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant retention</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants retained in full study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms (Beck Depression Inventory)</measure>
    <time_frame>6 months</time_frame>
    <description>Beck Depression Inventory to measure depressive symptoms. Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is 0 and the maximum total score is 63. Higher scores denote worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Strength of Connectivity in DMN (Default Mode Network)</measure>
    <time_frame>6 months</time_frame>
    <description>Default Mode Network Connectivity will be measured using fMRI at rest and while processing emotional pictures before and after volunteering intervention. The strength of connectivity within the DMN will be calculated by averaging attributes for each node in the DMN.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope scale (Abler et al., 2017)</measure>
    <time_frame>6 months</time_frame>
    <description>Hope scale (Abler et al., 2017) will be measured on a scale from 1 (strongly disagree) to 5 (strongly agree). Items will be averaged; higher scores denote better outcome (more hope).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Hopelessness Inventory</measure>
    <time_frame>6 months</time_frame>
    <description>Beck Hopelessness Inventory will be used (scored from 1-20; higher score denotes worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>6 months</time_frame>
    <description>NIH toolbox measure from 1 (never) to 5 (very often); scores will be averaged and high score indicates more self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orientation Toward Others</measure>
    <time_frame>6 months</time_frame>
    <description>5 point scale from 1=strongly disagree to 5=strongly agree. Scores will be averaged; higher score denotes more orientation toward others.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empathy</measure>
    <time_frame>6 months</time_frame>
    <description>IRI (Interpersonal Reactivity Index) subscale to measure empathy on a 5 point scale from 1- strongly disagree to 5 -strongly agree. Scores will be averaged; higher score denotes more empathy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Experience in Volunteering</measure>
    <time_frame>6 months</time_frame>
    <description>Measured through the Inventory of Service Experience (Taylor &amp; Pancer, 2007) on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores will be averaged for subscales of the measure. Higher score denotes better outcomes (more positive experiences with volunteering).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Depression</condition>
  <condition>Adolescent Behavior</condition>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Adolescent Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be assigned to participate in community service (from a menu of options) for 30 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Volunteer experience</intervention_name>
    <description>Participants will be assigned to a meaningful volunteer experience from a menu of local options (e.g., volunteering at an animal shelter or in a library) for 30 hours.</description>
    <arm_group_label>Adolescent Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 14-20&#xD;
&#xD;
          -  new mild to moderate depression diagnosis (single episode)&#xD;
&#xD;
          -  new mild to moderate anxiety diagnosis&#xD;
&#xD;
          -  new adjustment disorder diagnosis&#xD;
&#xD;
          -  have been in treatment for &lt; 8 months&#xD;
&#xD;
          -  right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of recurrent depressive, anxiety or adjustment disorder episodes&#xD;
&#xD;
          -  have been in treatment &gt; 8 months&#xD;
&#xD;
          -  left-handed&#xD;
&#xD;
          -  expressing suicidal ideation&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  any contraindications for completing an MRI scan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Parissa Ballard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Trinity Center, Inc</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriCare, PA</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Beck, J. S. (2011). Cognitive behavior therapy: Basics and beyond: Guilford Press</citation>
  </reference>
  <reference>
    <citation>Beesdo K, Hofler M, Leibenluft E, Lieb R, Bauer M, Pfennig A. Mood episodes and mood disorders: patterns of incidence and conversion in the first three decades of life. Bipolar Disord. 2009 Sep;11(6):637-49. doi: 10.1111/j.1399-5618.2009.00738.x.</citation>
    <PMID>19689506</PMID>
  </reference>
  <reference>
    <citation>Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.</citation>
    <PMID>16199119</PMID>
  </reference>
  <reference>
    <citation>Gudayol-Ferre E, Pero-Cebollero M, Gonzalez-Garrido AA, Guardia-Olmos J. Changes in brain connectivity related to the treatment of depression measured through fMRI: a systematic review. Front Hum Neurosci. 2015 Nov 3;9:582. doi: 10.3389/fnhum.2015.00582. eCollection 2015.</citation>
    <PMID>26578927</PMID>
  </reference>
  <reference>
    <citation>Kessler RC, Avenevoli S, Ries Merikangas K. Mood disorders in children and adolescents: an epidemiologic perspective. Biol Psychiatry. 2001 Jun 15;49(12):1002-14. doi: 10.1016/s0006-3223(01)01129-5.</citation>
    <PMID>11430842</PMID>
  </reference>
  <reference>
    <citation>Sheline YI, Barch DM, Price JL, Rundle MM, Vaishnavi SN, Snyder AZ, Mintun MA, Wang S, Coalson RS, Raichle ME. The default mode network and self-referential processes in depression. Proc Natl Acad Sci U S A. 2009 Feb 10;106(6):1942-7. doi: 10.1073/pnas.0812686106. Epub 2009 Jan 26.</citation>
    <PMID>19171889</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescents</keyword>
  <keyword>FMRI</keyword>
  <keyword>volunteerism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03816215/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03816215
org study id: IRB00053435
nct id: NCT03816215
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the present study is to test in a preliminary manner an innovative strategy
      for treating depression among adolescents (alongside existing therapy) using community
      volunteerism.
The purpose of the present study is to test in a preliminary manner an innovative strategy
      for treating depression among adolescents (alongside existing therapy) using community
      volunteerism. In addition, this study will test a potential mechanism by which volunteering
      might decrease depressive symptoms: increasing psychosocial assets, specifically decreasing
      self-orientation and increasing an orientation toward others. This will be measured through
      self-report as well as using functional magnetic resonance imaging (fMRI). This study will be
      the first study to explore how neural response patterns are potentially altered by intense
      experiences with volunteerism among depressed adolescents.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participant recruitment
time frame: 6 months
description: Number of participants screened (reported by clinical mental health providers)
measure: Participant retention
time frame: 6 months
description: Number of participants retained in full study
measure: Depressive symptoms (Beck Depression Inventory)
time frame: 6 months
description: Beck Depression Inventory to measure depressive symptoms. Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is 0 and the maximum total score is 63. Higher scores denote worse outcome
measure: Strength of Connectivity in DMN (Default Mode Network)
time frame: 6 months
description: Default Mode Network Connectivity will be measured using fMRI at rest and while processing emotional pictures before and after volunteering intervention. The strength of connectivity within the DMN will be calculated by averaging attributes for each node in the DMN.
measure: Hope scale (Abler et al., 2017)
time frame: 6 months
description: Hope scale (Abler et al., 2017) will be measured on a scale from 1 (strongly disagree) to 5 (strongly agree). Items will be averaged; higher scores denote better outcome (more hope).
measure: Beck Hopelessness Inventory
time frame: 6 months
description: Beck Hopelessness Inventory will be used (scored from 1-20; higher score denotes worse outcome).
measure: Self-efficacy
time frame: 6 months
description: NIH toolbox measure from 1 (never) to 5 (very often); scores will be averaged and high score indicates more self-efficacy.
measure: Orientation Toward Others
time frame: 6 months
description: 5 point scale from 1=strongly disagree to 5=strongly agree. Scores will be averaged; higher score denotes more orientation toward others.
measure: Empathy
time frame: 6 months
description: IRI (Interpersonal Reactivity Index) subscale to measure empathy on a 5 point scale from 1- strongly disagree to 5 -strongly agree. Scores will be averaged; higher score denotes more empathy.
measure: Experience in Volunteering
time frame: 6 months
description: Measured through the Inventory of Service Experience (Taylor & Pancer, 2007) on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores will be averaged for subscales of the measure. Higher score denotes better outcomes (more positive experiences with volunteering).
arm group label: Adolescent Participants
arm group type: Experimental
description: Participants will be assigned to participate in community service (from a menu of options) for 30 hours.
intervention type: Behavioral
intervention name: Volunteer experience
description: Participants will be assigned to a meaningful volunteer experience from a menu of local options (e.g., volunteering at an animal shelter or in a library) for 30 hours.
arm group label: Adolescent Participants
criteria: 
gender: All
minimum age: 14 Years
maximum age: 20 Years
healthy volunteers: No
last name: Parissa Ballard, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
facility: 
facility: 
country: United States
citation: Beck, J. S. (2011). Cognitive behavior therapy: Basics and beyond: Guilford Press
citation: Beesdo K, Hofler M, Leibenluft E, Lieb R, Bauer M, Pfennig A. Mood episodes and mood disorders: patterns of incidence and conversion in the first three decades of life. Bipolar Disord. 2009 Sep;11(6):637-49. doi: 10.1111/j.1399-5618.2009.00738.x.
PMID: 19689506
citation: Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.
PMID: 16199119
citation: Gudayol-Ferre E, Pero-Cebollero M, Gonzalez-Garrido AA, Guardia-Olmos J. Changes in brain connectivity related to the treatment of depression measured through fMRI: a systematic review. Front Hum Neurosci. 2015 Nov 3;9:582. doi: 10.3389/fnhum.2015.00582. eCollection 2015.
PMID: 26578927
citation: Kessler RC, Avenevoli S, Ries Merikangas K. Mood disorders in children and adolescents: an epidemiologic perspective. Biol Psychiatry. 2001 Jun 15;49(12):1002-14. doi: 10.1016/s0006-3223(01)01129-5.
PMID: 11430842
citation: Sheline YI, Barch DM, Price JL, Rundle MM, Vaishnavi SN, Snyder AZ, Mintun MA, Wang S, Coalson RS, Raichle ME. The default mode network and self-referential processes in depression. Proc Natl Acad Sci U S A. 2009 Feb 10;106(6):1942-7. doi: 10.1073/pnas.0812686106. Epub 2009 Jan 26.
PMID: 19171889
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
provided document: 