<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/NCT04419168</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20110346</org_study_id>
    <secondary_id>CER-2018C2-13320 20</secondary_id>
    <nct_id>NCT04419168</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications</brief_title>
  <acronym>CaRISMA</acronym>
  <official_title>Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</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 investigators are conducting a comparative effectiveness trial among adult patients with&#xD;
      sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either&#xD;
      mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital&#xD;
      education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent&#xD;
      if requested or needed) follow-up with a health coach for at least 3 months to reinforce&#xD;
      learned materials. Both groups will also use their mobile device to track daily pain, mood,&#xD;
      and medication used for two-week periods at baseline and each of the follow-up points (3, 6&#xD;
      and 12 months). Participants will also be given access to a study-associated online support&#xD;
      group page where members can discuss with other patients, issues participants faced and what&#xD;
      skills were or could be used to address them. Participants will continue all routine care&#xD;
      including opioid pain management and novel therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study interventions are both Internet-delivered, evidence-based tools that have been&#xD;
      tailored specifically for the target population through a user-centered approach that has&#xD;
      engaged stakeholders at each stage of the process.&#xD;
&#xD;
        1. Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach&#xD;
           users how to recognize negative thoughts and emotions, use cognitive skills and&#xD;
           problem-solving, and apply coping behaviors such as distraction, activity scheduling,&#xD;
           and relaxation. The cCBT arm emphasizes skills acquisition and learning through&#xD;
           practice; this intervention is consistent with the tailored behavioral services patients&#xD;
           would receive individually or as a group when working with a psychologist or behavioral&#xD;
           pain specialist.&#xD;
&#xD;
        2. Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education&#xD;
           program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and&#xD;
           exercise), and facts about SCD. This program is consistent with the education patients&#xD;
           and families would receive with a patient educator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>comparative effectiveness trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain interference</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>- PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale a validated questionnaire that assesses how day-to-day function is altered by pain. Range 8-40, higher scores may mean that pain limits your activity level and enjoyment of certain activities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Daily pain intensity</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>Daily pain intensity: 3, 6 and 12-month change in average daily pain intensity &quot;Using any number from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable, what is your pain level today?&quot;</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Depression, Anxiety</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>cCBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>m-Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Convenience Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Not participating in the intervention. Participants will complete the baseline questionnaire battery only and we will abstract their medical record data for the 12-months before enrollment and 12-months post enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cCBT</intervention_name>
    <description>A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.</description>
    <arm_group_label>cCBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>m-Education</intervention_name>
    <description>A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.</description>
    <arm_group_label>m-Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People with any type of sickle cell disease&#xD;
&#xD;
          -  Male or female, age 18 years or older&#xD;
&#xD;
          -  Reports chronic pain: i.e pain more days that not for the past 3 months or longer&#xD;
             and/or is prescribed daily or long-acting opioids for pain.&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any potential participants who fail consent comprehension questions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Illinous-Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27858</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Kaleab Abebe, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>sickle cell disease</keyword>
  <keyword>pain</keyword>
  <keyword>opioids</keyword>
  <keyword>depression</keyword>
  <keyword>cognitive behavioral therapy</keyword>
  <keyword>mobile technology</keyword>
  <keyword>digital health</keyword>
  <keyword>mHealth</keyword>
  <keyword>implementation science</keyword>
  <keyword>community-based participatory research</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Depression</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/NCT04419168
org study id: STUDY20110346
secondary id: CER-2018C2-13320 20
nct id: NCT04419168
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators are conducting a comparative effectiveness trial among adult patients with
      sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either
      mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital
      education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent
      if requested or needed) follow-up with a health coach for at least 3 months to reinforce
      learned materials. Both groups will also use their mobile device to track daily pain, mood,
      and medication used for two-week periods at baseline and each of the follow-up points (3, 6
      and 12 months). Participants will also be given access to a study-associated online support
      group page where members can discuss with other patients, issues participants faced and what
      skills were or could be used to address them. Participants will continue all routine care
      including opioid pain management and novel therapies.
The study interventions are both Internet-delivered, evidence-based tools that have been
      tailored specifically for the target population through a user-centered approach that has
      engaged stakeholders at each stage of the process.

        1. Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach
           users how to recognize negative thoughts and emotions, use cognitive skills and
           problem-solving, and apply coping behaviors such as distraction, activity scheduling,
           and relaxation. The cCBT arm emphasizes skills acquisition and learning through
           practice; this intervention is consistent with the tailored behavioral services patients
           would receive individually or as a group when working with a psychologist or behavioral
           pain specialist.

        2. Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education
           program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and
           exercise), and facts about SCD. This program is consistent with the education patients
           and families would receive with a patient educator.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: comparative effectiveness trial
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Pain interference
time frame: 3, 6, 12 months
description: - PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale a validated questionnaire that assesses how day-to-day function is altered by pain. Range 8-40, higher scores may mean that pain limits your activity level and enjoyment of certain activities
measure: Change in Daily pain intensity
time frame: 3, 6, 12 months
description: Daily pain intensity: 3, 6 and 12-month change in average daily pain intensity "Using any number from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable, what is your pain level today?"
arm group label: cCBT
arm group type: Experimental
description: Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.
arm group label: m-Education
arm group type: Experimental
description: Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.
arm group label: Convenience Comparison
arm group type: No Intervention
description: Not participating in the intervention. Participants will complete the baseline questionnaire battery only and we will abstract their medical record data for the 12-months before enrollment and 12-months post enrollment.
intervention type: Other
intervention name: cCBT
description: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
arm group label: cCBT
intervention type: Other
intervention name: m-Education
description: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.
arm group label: m-Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Kaleab Abebe, PhD
investigator title: Associate Professor
mesh term: Chronic Pain
mesh term: Depression
sharing ipd: No