<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/NCT03234439</url>
  </required_header>
  <id_info>
    <org_study_id>2017/06/13</org_study_id>
    <nct_id>NCT03234439</nct_id>
  </id_info>
  <brief_title>Digital Tools for Coping With Chronic Pain</brief_title>
  <official_title>Digital Tools for Coping With Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MyStrength, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MyStrength, Inc.</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>
      Chronic pain is becoming increasingly more prevalent worldwide. High rates of co-morbid&#xD;
      psychological distress are also commonly found among individuals living with chronic pain.&#xD;
      Often requiring a multi-modal treatment approach, a growing body of literature suggests that&#xD;
      digital behavioral health interventions and tools may serve as promising complementary&#xD;
      options to help individuals cope with the pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research objective is to evaluate the effectiveness of the myStrength product offerings,&#xD;
      namely the chronic pain focus area, on study participants' functional well-being over time.&#xD;
      The research questions to be answered include the following:&#xD;
&#xD;
        1. Do study participants who are randomized to the myStrength intervention arm experience&#xD;
           change in their self-reported ability to function, outlook on pain, and/or perception of&#xD;
           prescription opioids.&#xD;
&#xD;
        2. Do study participants who are randomized to the myStrength intervention arm experience&#xD;
           change in terms of their behavioral health, such as anxiety and depression levels,&#xD;
           during the study period.&#xD;
&#xD;
      The study team hypothesizes that myStrength study participants will achieve a higher level of&#xD;
      functioning and adopt a more positive outlook toward their pain management as compared to the&#xD;
      waitlist control group. Self-assessments will be repeated throughout the study period to&#xD;
      capture the inflection point of change as well as the sustainability of these changes over&#xD;
      time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</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>
    <intervention_model_description>Double-arm, waitlist control trail with 1:1 randomization</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months</measure>
    <time_frame>Repeated measures over time: baseline and day 180</time_frame>
    <description>Measure ability to function in the presence of chronic pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in baseline PHQ9 at 6 months</measure>
    <time_frame>Repeated measures over time: baseline and day 180</time_frame>
    <description>Measure self-reported depression symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline Current Opioid Misuse Measure at 6 months</measure>
    <time_frame>Repeated measures over time: baseline and day 180</time_frame>
    <description>Screen for maladaptive opioid use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline confidence to live with chronic pain as measured by Pain Self-Efficacy Scale at 6 months</measure>
    <time_frame>Repeated measures over time: baseline and day 180</time_frame>
    <description>Measure ability to function in the presence of chronic pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline and GAD7 at 6 months</measure>
    <time_frame>Repeated measures over time: baseline and day 180</time_frame>
    <description>Measure self-reported anxiety symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>myStrength Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The myStrength intervention arm will be encouraged to utilize the chronic pain offering consisting of 6 modules. Each module has 5 activities and can take on average 5-15 minutes to complete. Study participants assigned to the myStrength intervention will have one week to complete each module. In addition to completing the required chronic pain modules, study participants in the myStrength intervention arm will have the option to also select other areas of interest and complete corresponding activities at their own pace. myStrength utilization will be recorded and analyzed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The waitlist control group will gain access to the myStrength platform 60 days following the start of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>myStrength</intervention_name>
    <description>myStrength is a digital self-care behavioral and wellness platform</description>
    <arm_group_label>myStrength Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Study participants must be 18 years of age or older&#xD;
&#xD;
          2. Self-report chronic pain lasting for at least the past 3 months but no more than 9&#xD;
             months (examples include lower back pain, arthritis, chronic headaches, neuropathic&#xD;
             pain, knee pain)&#xD;
&#xD;
          3. Must have considered, have a history of, or are currently taking a prescription opioid&#xD;
             for chronic pain (examples oxycodone (OxyContin, Percodan, Percocet), hydrocodone&#xD;
             (Vicodin, Lortab, Lorcet), morphine (Kadian, Avinza, MS Contin), fentanyl (Duragesic),&#xD;
             propoxyphene (Darvon), hydromorphone (Dilaudid)&#xD;
&#xD;
          4. Fluent in English and articulate Access to a laptop or mobile device to access email&#xD;
             and the myStrength platform&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Under the age of 18&#xD;
&#xD;
          2. Chronic pain due to cancer&#xD;
&#xD;
          3. Chronic pain &lt;3 months or &gt; 9 months&#xD;
&#xD;
          4. Prior exposure to the myStrength platform&#xD;
&#xD;
          5. Self-reported history of hospitalization for mental illness or a substance use&#xD;
             disorder&#xD;
&#xD;
          6. Receiving government benefits related to a developmental or behavioral health&#xD;
             disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Krista Schladweiler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MyStrength, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigslist</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>digital behavioral health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <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/NCT03234439
org study id: 2017/06/13
nct id: NCT03234439
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic pain is becoming increasingly more prevalent worldwide. High rates of co-morbid
      psychological distress are also commonly found among individuals living with chronic pain.
      Often requiring a multi-modal treatment approach, a growing body of literature suggests that
      digital behavioral health interventions and tools may serve as promising complementary
      options to help individuals cope with the pain.
The research objective is to evaluate the effectiveness of the myStrength product offerings,
      namely the chronic pain focus area, on study participants' functional well-being over time.
      The research questions to be answered include the following:

        1. Do study participants who are randomized to the myStrength intervention arm experience
           change in their self-reported ability to function, outlook on pain, and/or perception of
           prescription opioids.

        2. Do study participants who are randomized to the myStrength intervention arm experience
           change in terms of their behavioral health, such as anxiety and depression levels,
           during the study period.

      The study team hypothesizes that myStrength study participants will achieve a higher level of
      functioning and adopt a more positive outlook toward their pain management as compared to the
      waitlist control group. Self-assessments will be repeated throughout the study period to
      capture the inflection point of change as well as the sustainability of these changes over
      time.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-arm, waitlist control trail with 1:1 randomization
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months
time frame: Repeated measures over time: baseline and day 180
description: Measure ability to function in the presence of chronic pain
measure: Change in baseline PHQ9 at 6 months
time frame: Repeated measures over time: baseline and day 180
description: Measure self-reported depression symptoms
measure: Change in baseline Current Opioid Misuse Measure at 6 months
time frame: Repeated measures over time: baseline and day 180
description: Screen for maladaptive opioid use
measure: Change in baseline confidence to live with chronic pain as measured by Pain Self-Efficacy Scale at 6 months
time frame: Repeated measures over time: baseline and day 180
description: Measure ability to function in the presence of chronic pain
measure: Change in baseline and GAD7 at 6 months
time frame: Repeated measures over time: baseline and day 180
description: Measure self-reported anxiety symptoms
arm group label: myStrength Intervention
arm group type: Experimental
description: The myStrength intervention arm will be encouraged to utilize the chronic pain offering consisting of 6 modules. Each module has 5 activities and can take on average 5-15 minutes to complete. Study participants assigned to the myStrength intervention will have one week to complete each module. In addition to completing the required chronic pain modules, study participants in the myStrength intervention arm will have the option to also select other areas of interest and complete corresponding activities at their own pace. myStrength utilization will be recorded and analyzed.
arm group label: Waitlist Control
arm group type: No Intervention
description: The waitlist control group will gain access to the myStrength platform 60 days following the start of the study.
intervention type: Behavioral
intervention name: myStrength
description: myStrength is a digital self-care behavioral and wellness platform
arm group label: myStrength Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Krista Schladweiler, PhD
role: Principal Investigator
affiliation: MyStrength, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No