<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/NCT03776890</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100183</org_study_id>
    <nct_id>NCT03776890</nct_id>
  </id_info>
  <brief_title>DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk</brief_title>
  <official_title>DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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 this research study is to determine whether a positive psychology intervention&#xD;
      paired with a health behavior intervention is successful in decreasing perceived stress and&#xD;
      increasing positive affect in residents of Vance and Granville County. Participants will&#xD;
      attend 4 classes that occur once a week. The first class will focus on nutrition, the second&#xD;
      class will focus on exercise, the 3rd class will focus on tobacco use, and the 4th class that&#xD;
      will review the previous 3 classes and help participants incorporate the strategies taught in&#xD;
      the Destress for Health Program into their everyday lives. The duration of each class is 1&#xD;
      hour and the classes will be held once a week for a total of 4 weeks. Participants in this&#xD;
      research study will be asked to complete 2 surveys. The first survey will occur during class&#xD;
      1, and will ask participants about their demographic information, health behaviors, stress&#xD;
      levels, emotions, and behaviors. The second survey will be conducted over the phone and will&#xD;
      occur 30-days after the final class and will ask participants about their health behaviors,&#xD;
      stress levels, emotions, behaviors and also about whether or not they felt the classes they&#xD;
      attended were useful to them. Total study duration is about 2 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">February 6, 2020</completion_date>
  <primary_completion_date type="Actual">February 6, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Recruited in a 6-Month Time-frame</measure>
    <time_frame>6 Months</time_frame>
    <description>Measured via subject enrollment log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants That Stay in Study for Duration</measure>
    <time_frame>3 Months</time_frame>
    <description>Measured via subject enrollment log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants That Attend All Intervention Sessions</measure>
    <time_frame>3 Months</time_frame>
    <description>Measured via subject enrollment log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Participants Rating Intervention as Useful</measure>
    <time_frame>3 Months</time_frame>
    <description>Measured on a scale from 1-5 with 1 being &quot;Not Useful at All&quot; and 5 being &quot;Extremely Useful&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Participants Recommending Intervention to Friend</measure>
    <time_frame>3 Months</time_frame>
    <description>Measured on a scale from 1-5 with 1 being &quot;Not at All&quot; and 5 being &quot;Extremely&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Stress Self Regulation As Measured By a Survey</measure>
    <time_frame>Baseline, 3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Positive Emotion As Measured by a Survey</measure>
    <time_frame>Baseline, 3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Behavioral Self Regulation As Measured by a Survey</measure>
    <time_frame>Baseline, 3 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Stress Reduction</condition>
  <arm_group>
    <arm_group_label>DeStress for Health Program Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rural residents 18 years and older of Granville and Vance counties (n=30) will be recruited to participate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DeStress for Health Program</intervention_name>
    <description>The program will consist of 4 in person sessions that are based on empirically supported Positive Psychosocial Well-Being PPWB components including Optimism, Mindfulness, Positive Reprisal as well as Strengths-based Cognitive Behavioral Therapy (SBCBT) to improve behavioral self-regulation towards health-related goals. Research staff will conduct face-to-face surveys with participants at baseline and at end of program. Finally, we will conduct a phone-based survey 30 days after program completion to assess sustainability of intervention effects.</description>
    <arm_group_label>DeStress for Health Program Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Live in Granville or Vance Counties;&#xD;
&#xD;
          -  &gt;18 years old;&#xD;
&#xD;
          -  Interested in participating a stress reduction study&#xD;
&#xD;
          -  Speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does Not Live in Granville or Vance Counties&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Not interested in participating in a stress reduction study&#xD;
&#xD;
          -  Does not speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Devon Noonan, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Granville Vance Public Health Department</name>
      <address>
        <city>Oxford</city>
        <state>North Carolina</state>
        <zip>27565</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stress reduction</keyword>
  <keyword>rural</keyword>
  <keyword>health behaviors</keyword>
  <keyword>north carolina</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03776890
org study id: Pro00100183
nct id: NCT03776890
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to determine whether a positive psychology intervention
      paired with a health behavior intervention is successful in decreasing perceived stress and
      increasing positive affect in residents of Vance and Granville County. Participants will
      attend 4 classes that occur once a week. The first class will focus on nutrition, the second
      class will focus on exercise, the 3rd class will focus on tobacco use, and the 4th class that
      will review the previous 3 classes and help participants incorporate the strategies taught in
      the Destress for Health Program into their everyday lives. The duration of each class is 1
      hour and the classes will be held once a week for a total of 4 weeks. Participants in this
      research study will be asked to complete 2 surveys. The first survey will occur during class
      1, and will ask participants about their demographic information, health behaviors, stress
      levels, emotions, and behaviors. The second survey will be conducted over the phone and will
      occur 30-days after the final class and will ask participants about their health behaviors,
      stress levels, emotions, behaviors and also about whether or not they felt the classes they
      attended were useful to them. Total study duration is about 2 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants Recruited in a 6-Month Time-frame
time frame: 6 Months
description: Measured via subject enrollment log
measure: Percentage of Participants That Stay in Study for Duration
time frame: 3 Months
description: Measured via subject enrollment log
measure: Percentage of Participants That Attend All Intervention Sessions
time frame: 3 Months
description: Measured via subject enrollment log
measure: Percent of Participants Rating Intervention as Useful
time frame: 3 Months
description: Measured on a scale from 1-5 with 1 being "Not Useful at All" and 5 being "Extremely Useful".
measure: Percent of Participants Recommending Intervention to Friend
time frame: 3 Months
description: Measured on a scale from 1-5 with 1 being "Not at All" and 5 being "Extremely".
measure: Change in Stress Self Regulation As Measured By a Survey
time frame: Baseline, 3 Months
measure: Change in Positive Emotion As Measured by a Survey
time frame: Baseline, 3 Months
measure: Change in Behavioral Self Regulation As Measured by a Survey
time frame: Baseline, 3 Months
arm group label: DeStress for Health Program Participants
arm group type: Experimental
description: Rural residents 18 years and older of Granville and Vance counties (n=30) will be recruited to participate.
intervention type: Behavioral
intervention name: DeStress for Health Program
description: The program will consist of 4 in person sessions that are based on empirically supported Positive Psychosocial Well-Being PPWB components including Optimism, Mindfulness, Positive Reprisal as well as Strengths-based Cognitive Behavioral Therapy (SBCBT) to improve behavioral self-regulation towards health-related goals. Research staff will conduct face-to-face surveys with participants at baseline and at end of program. Finally, we will conduct a phone-based survey 30 days after program completion to assess sustainability of intervention effects.
arm group label: DeStress for Health Program Participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Devon Noonan, Ph.D
role: Principal Investigator
affiliation: Duke School of Nursing
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No