xml: <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/NCT06000007</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00016340</org_study_id>
      <secondary_id>1R44AT011593-01</secondary_id>
      <nct_id>NCT06000007</nct_id>
    </id_info>
    <brief_title>Digital Therapeutic for Chronic Pain Feasibility Study</brief_title>
    <official_title>Development and Implementation of a Behavioral Digital Therapeutic Designed to Support, Educate, Screen and Remotely Monitor Patients With Chronic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Washington</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1)&#xD;
        the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility&#xD;
        of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger&#xD;
        efficacy trial based on our primary outcomes. The intervention arm will test a mobile app&#xD;
        that aims to help people reduce pain interference who have chronic pain, as well as mental&#xD;
        health issues with depression and anxiety. Participants in the intervention arm will also&#xD;
        have the option to sense health data with a tracker that integrates with the app, which will&#xD;
        inform the feasibility of this feature.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the&#xD;
        form of a mobile app, as a digital therapeutic for improving patients' pain self management&#xD;
        and function who suffer from chronic pain. Specifically, the investigators will conduct a&#xD;
        2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the&#xD;
        mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial,&#xD;
        and 3) estimate the effect size for planning for a larger efficacy trial based on our primary&#xD;
        outcomes. The intervention arm will test a mobile app that aims to help people reduce pain&#xD;
        interference who have chronic pain, as well as mental health issues with depression and&#xD;
        anxiety. Participants in the intervention arm will also have the option to sense health data&#xD;
        with a tracker that integrates with the app, which will inform the feasibility of this&#xD;
        feature.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <phase>Phase 3</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>Randomized control feasibility study with two arms: intervention arm vs. control arm</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PROMIS Pain Interference Scale - Short Form 6b</measure>
      <time_frame>will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)</time_frame>
      <description>Brief survey of patient's perceived pain interference in their ability to function; scores are normed on a T-score with 50 as the mean, 10 as the standard deviation, and higher scores are worse</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire 9 (PHQ-9)</measure>
      <time_frame>will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)</time_frame>
      <description>depression symptom measure; scores range from 0 to 27; higher scores are worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder 7 (GAD-7)</measure>
      <time_frame>will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)</time_frame>
      <description>anxiety symptom measure; scores range from 0-21; higher scores are worse</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>Treatment as usual</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Treatment as usual arm entails the patients continuing to receive care from their primary care provider and any specialists they choose to get involved in their care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app</intervention_name>
      <description>2Morrow Chronic Pain Self-Management Program is delivered via a mobile app that engaged patients in evidenced based psychotherapy for chronic pain, including Acceptance and Commitment Therapy and Cognitive Behavioral Therapy based activities, to improve a patient's pain self management. The mobile app also offers the ability to track activities, screen for other problems, support for communicating with medical providers, and access a coach via texting.</description>
      <arm_group_label>Intervention arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Treatment as usual</intervention_name>
      <description>Treatment as usual entails continuing with treatment for chronic pain with the patient's primary care provider and any potential specialists they choose to engage with.</description>
      <arm_group_label>Treatment as usual</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt;=18 years old&#xD;
  &#xD;
            -  at least one ICD pain related diagnosis noted in the electronic health record (EHR)&#xD;
  &#xD;
            -  at least 2 visits in a primary care clinic with at least one in the last 12 months&#xD;
  &#xD;
            -  willing to use a mobile app in English&#xD;
  &#xD;
            -  T-score for the PROMIS brief pain inventory of &gt;= 55&#xD;
  &#xD;
            -  access to a smartphone&#xD;
  &#xD;
            -  willing to download and use a mobile app daily&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  current cancer related diagnosis (to exclude cancer related chronic pain)&#xD;
  &#xD;
            -  plans for surgery in next 3 months&#xD;
  &#xD;
            -  pregnant&#xD;
  &#xD;
            -  currently receiving hospice care&#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>Kari A Stephens, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brennan Keiser, MSW</last_name>
      <phone>206-221-7863</phone>
      <email>bkeiser@uw.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Washington Primary Care</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98116</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kari A Stephens, PhD</last_name>
        <phone>206-221-0349</phone>
        <email>kstephen@uw.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Kari Stephens</investigator_full_name>
      <investigator_title>Professor of Family Medicine</investigator_title>
    </responsible_party>
    <keyword>chronic pain</keyword>
    <keyword>primary care</keyword>
    <keyword>digital therapeutic</keyword>
    <keyword>mobile app</keyword>
    <keyword>pain function</keyword>
    <keyword>pain interference</keyword>
    <keyword>psychotherapy</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>Yes</sharing_ipd>
      <ipd_description>Data will be made upon request after evaluation for appropriateness by principal investigator as an appropriate research request by individuals seeking to do further research. All data will be de-identified to protect participant privacy.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Sharing will occur after the publication of the final outcomes of the study are published and will be available for up to 7 years post completion of data collection.</ipd_time_frame>
      <ipd_access_criteria>The requestor must provide acceptable research justification and appropriate permissions from their institutional to use the data requested for specific and detailed research purposes.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000007
  org study id: STUDY00016340
  secondary id: 1R44AT011593-01
  nct id: NCT06000007
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1)
        the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility
        of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger
        efficacy trial based on our primary outcomes. The intervention arm will test a mobile app
        that aims to help people reduce pain interference who have chronic pain, as well as mental
        health issues with depression and anxiety. Participants in the intervention arm will also
        have the option to sense health data with a tracker that integrates with the app, which will
        inform the feasibility of this feature.
  This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the
        form of a mobile app, as a digital therapeutic for improving patients' pain self management
        and function who suffer from chronic pain. Specifically, the investigators will conduct a
        2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the
        mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial,
        and 3) estimate the effect size for planning for a larger efficacy trial based on our primary
        outcomes. The intervention arm will test a mobile app that aims to help people reduce pain
        interference who have chronic pain, as well as mental health issues with depression and
        anxiety. Participants in the intervention arm will also have the option to sense health data
        with a tracker that integrates with the app, which will inform the feasibility of this
        feature.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized control feasibility study with two arms: intervention arm vs. control arm
  primary purpose: Treatment
  masking: None (Open Label)
  measure: PROMIS Pain Interference Scale - Short Form 6b
  time frame: will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)
  description: Brief survey of patient's perceived pain interference in their ability to function; scores are normed on a T-score with 50 as the mean, 10 as the standard deviation, and higher scores are worse
  measure: Patient Health Questionnaire 9 (PHQ-9)
  time frame: will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)
  description: depression symptom measure; scores range from 0 to 27; higher scores are worse
  measure: Generalized Anxiety Disorder 7 (GAD-7)
  time frame: will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)
  description: anxiety symptom measure; scores range from 0-21; higher scores are worse
  arm group label: Treatment as usual
  arm group type: Active Comparator
  description: Treatment as usual arm entails the patients continuing to receive care from their primary care provider and any specialists they choose to get involved in their care.
  arm group label: Intervention arm
  arm group type: Active Comparator
  description: Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual
  intervention type: Device
  intervention name: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app
  description: 2Morrow Chronic Pain Self-Management Program is delivered via a mobile app that engaged patients in evidenced based psychotherapy for chronic pain, including Acceptance and Commitment Therapy and Cognitive Behavioral Therapy based activities, to improve a patient's pain self management. The mobile app also offers the ability to track activities, screen for other problems, support for communicating with medical providers, and access a coach via texting.
  arm group label: Intervention arm
  intervention type: Other
  intervention name: Treatment as usual
  description: Treatment as usual entails continuing with treatment for chronic pain with the patient's primary care provider and any potential specialists they choose to engage with.
  arm group label: Treatment as usual
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kari A Stephens, Ph.D.
  role: Principal Investigator
  affiliation: University of Washington
  last name: Brennan Keiser, MSW
  phone: 206-221-7863
  email: bkeiser@uw.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Kari Stephens
  investigator title: Professor of Family Medicine
  mesh term: Chronic Pain
  sharing ipd: Yes
  ipd description: Data will be made upon request after evaluation for appropriateness by principal investigator as an appropriate research request by individuals seeking to do further research. All data will be de-identified to protect participant privacy.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Sharing will occur after the publication of the final outcomes of the study are published and will be available for up to 7 years post completion of data collection.
  ipd access criteria: The requestor must provide acceptable research justification and appropriate permissions from their institutional to use the data requested for specific and detailed research purposes.