<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/NCT03029468</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17010378</org_study_id>
    <secondary_id>K23HL135396</secondary_id>
    <nct_id>NCT03029468</nct_id>
  </id_info>
  <brief_title>Computerized Cognitive Behavioral Therapy Assisted Life Management for Pain in Sickle Cell Disease</brief_title>
  <acronym>CALM-SCD</acronym>
  <official_title>A Three-arm Feasibility Study of Web- and Smartphone-delivered Cognitive Behavioral Therapy as an Adjunct to Opioid Pain Treatment Among Adults With Sickle Cell Disease (SCD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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 primary aim of this study is to test the feasibility and acceptability of implementing a&#xD;
      multimedia computerized cognitive behavioral therapy (cCBT) program for reducing SCD pain&#xD;
      symptoms in a single-arm pilot pragmatic clinical trial. The investigators will recruit 40&#xD;
      SCD patients with chronic pain and/or on chronic opioid pain treatment and randomize them 3:1&#xD;
      to two groups (cCBT and e-Education respectively), randomizing unevenly in order to best&#xD;
      gather feasibility data for the cCBT. Both groups will use a mobile app to track daily&#xD;
      pain/mood. The cCBT group will receive sessions of the CALM-SCD program to complete via&#xD;
      mobile device and will have weekly follow-up with a care coach. The Education group will&#xD;
      receive online education modules to complete via mobile device and will also have weekly&#xD;
      follow-up with a care coach. The primary outcomes of the trial include feasibility&#xD;
      (recruitment, retention, provider and patient feedback) and acceptability (sessions&#xD;
      completed) of the CALM-SCD program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to provide the experiences and data that will support a later,&#xD;
      larger, and adequately powered effectiveness trial of the CALM-SCD, computerized cognitive&#xD;
      behavioral therapy (cCBT) program. The investigators hypothesize that CALM-SCD is acceptable,&#xD;
      i.e., patients will use it (90% of users will complete the first lesson within 3 months; 70%&#xD;
      will complete³4 sessions; 50% of users will complete all 8 sessions), and feasible, i.e., the&#xD;
      investigators can recruit &gt;80% of patients approached, and &gt;90% of enrolled participants will&#xD;
      complete their 6-month follow-up assessment. The investigators will also have preliminary&#xD;
      data on effectiveness and hypothesize that 70% of cCBT users will achieve a &gt;50% decline in&#xD;
      daily pain ratings.&#xD;
&#xD;
      The investigators will enroll 40 SCD patients at the University of Pittsburgh Medical Center&#xD;
      (UPMC) with chronic pain to either CALM-SCD or pain education (eEducation) and follow them&#xD;
      for 12 months. Implementation of routine stress/pain screening in the UPMC Adult Sickle Cell&#xD;
      Clinic allows investigators to identify patients with SCD who have chronic pain as indicated&#xD;
      by self-report &quot;I have had pain nearly every day for at least 3 months&quot; or have been&#xD;
      prescribed long-acting opioids for pain.&#xD;
&#xD;
      Following confirmation of protocol-eligibility and informed consent, investigators will&#xD;
      provide all patients with a large-screen smartphone (unless the patient owns their own&#xD;
      compatible large-screen smartphone) with a symptoms diary app, and GPS tracking features&#xD;
      pre-installed; this will allow investigators to track pain and mood as well as any opioid or&#xD;
      non-opioid pain treatments used by patients, and steps traveled.&#xD;
&#xD;
      Patients enrolled in the CALM-SCD group will complete at least 4 1-hour cCBT sessions over 3&#xD;
      months using their personal or study-provided smartphone. Because cCBT programs are less&#xD;
      effective without a human support component, participants will also be introduced to a care&#xD;
      coach (master's level student tech who will receive training in CBT) who will contact them on&#xD;
      a weekly basis by phone/text for up to 3 months. The care coach will reinforce CBT materials&#xD;
      and encourage engagement. Participants will have continued access to the program after first&#xD;
      3 months, but care coach support will only be available on an as-needed basis.&#xD;
&#xD;
      Patients enrolled in the eEducation group will receive pain education through online modules&#xD;
      that they will be asked to complete using their study-provided smartphone. Each module&#xD;
      includes learning tasks, a reading assignment, and a short quiz based on material. The&#xD;
      education group will receive care coach contact on the same schedule as the cCBT group. The&#xD;
      care coach will provide supportive therapy and encouragement to complete modules and apply&#xD;
      the lessons to their daily life.&#xD;
&#xD;
      Patients who are not eligible or who are not randomized into one of the intervention arms of&#xD;
      this study will serve as a comparison group to ensure we are treating a representative sample&#xD;
      of patients. Further, patients who were eligible but were not randomized into one of the&#xD;
      intervention arms will serve as a usual care control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2018</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 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>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Three-arm feasibility trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of cognitive behavioral therapy trial for participants</measure>
    <time_frame>6 months</time_frame>
    <description>Number of cCBT sessions completed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of recruitment and enrollment into cognitive behavioral therapy trial</measure>
    <time_frame>3-6 months of open enrollment</time_frame>
    <description>Number of patients enrolled / number of patients screened and approached</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>Average change in 0-10 VAS pain intensity over course of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>PROMIS Pain Interference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>PHQ-9 depression measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>GAD-7 anxiety scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>Pain Catastrophizing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sickle Cell Self-efficacy Scale</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>Self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASCQ-Me</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>Quality of life measures</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Activity space</measure>
    <time_frame>6 months</time_frame>
    <description>GPS activity tracking on the smartphone</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Sickle Cell Disease</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Computerized CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computerized cognitive behavioral therapy (cCBT) for pain via an integrated smartphone and web-based skills training program: The training plan will help users learn 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; thus, the program involves regular homework assignments, and follow-up with the care coach and social network about issues faced and what skills were or could be used. 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>e-Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive pain education through online modules that they will be asked to complete using their personal or study-provided smartphone. Each module includes learning tasks, a reading assignment, and a short quiz based on material. The education group will receive care coach contact on the same schedule as the cCBT group. The care coach will provide supportive therapy and encouragement to complete modules and apply the lessons to their daily life.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants who are not eligible or who are not randomized into one of the intervention arms of this study will serve as a comparison group to ensure we are treating a representative sample of patients. Further, patients who were eligible but were not randomized into one of the intervention arms will serve as a usual care control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive behavioral therapy</intervention_name>
    <description>CBT teaches 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.</description>
    <arm_group_label>Computerized CBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eEducation</intervention_name>
    <description>Pain and sickle cell disease education delivered through a mobile electronic device</description>
    <arm_group_label>e-Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be eligible for the study, patients must be 18 years of age or older, have a&#xD;
             documented diagnosis of SCD (HgbSS, HgbSC, SB+Thal, or SBoThal), receive routine care&#xD;
             at the UPMC Sickle Cell Clinic, and self-report chronic pain or have been prescribed&#xD;
             long-acting opioids for pain.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent due to low literacy or cognitive difficulties&#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>Charles Jonassaint, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Charles Jonassaint</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Cognitive behavioral therapy</keyword>
  <keyword>Chronic pain</keyword>
  <keyword>Sickle cell disease</keyword>
  <keyword>Mobile phone app</keyword>
  <keyword>Mental health</keyword>
  <keyword>Behavioral intervention</keyword>
  <keyword>Behavioral health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>A public-use data set (PUD) will be available through our study website. The PUD will be a cleaned, de-identified copy that includes all enrolled participants. Sensitive, identifying, unreliable, or invalid data will be excluded.&#xD;
Researchers may request a copy of the PUD electronically from the Clinical Research Services at the University of Pittsburgh, conditional upon receiving IRB approval for a research proposal from their home institution.</ipd_description>
  </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/NCT03029468
org study id: PRO17010378
secondary id: K23HL135396
nct id: NCT03029468
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to test the feasibility and acceptability of implementing a
      multimedia computerized cognitive behavioral therapy (cCBT) program for reducing SCD pain
      symptoms in a single-arm pilot pragmatic clinical trial. The investigators will recruit 40
      SCD patients with chronic pain and/or on chronic opioid pain treatment and randomize them 3:1
      to two groups (cCBT and e-Education respectively), randomizing unevenly in order to best
      gather feasibility data for the cCBT. Both groups will use a mobile app to track daily
      pain/mood. The cCBT group will receive sessions of the CALM-SCD program to complete via
      mobile device and will have weekly follow-up with a care coach. The Education group will
      receive online education modules to complete via mobile device and will also have weekly
      follow-up with a care coach. The primary outcomes of the trial include feasibility
      (recruitment, retention, provider and patient feedback) and acceptability (sessions
      completed) of the CALM-SCD program.
The objective of this study is to provide the experiences and data that will support a later,
      larger, and adequately powered effectiveness trial of the CALM-SCD, computerized cognitive
      behavioral therapy (cCBT) program. The investigators hypothesize that CALM-SCD is acceptable,
      i.e., patients will use it (90% of users will complete the first lesson within 3 months; 70%
      will complete³4 sessions; 50% of users will complete all 8 sessions), and feasible, i.e., the
      investigators can recruit >80% of patients approached, and >90% of enrolled participants will
      complete their 6-month follow-up assessment. The investigators will also have preliminary
      data on effectiveness and hypothesize that 70% of cCBT users will achieve a >50% decline in
      daily pain ratings.

      The investigators will enroll 40 SCD patients at the University of Pittsburgh Medical Center
      (UPMC) with chronic pain to either CALM-SCD or pain education (eEducation) and follow them
      for 12 months. Implementation of routine stress/pain screening in the UPMC Adult Sickle Cell
      Clinic allows investigators to identify patients with SCD who have chronic pain as indicated
      by self-report "I have had pain nearly every day for at least 3 months" or have been
      prescribed long-acting opioids for pain.

      Following confirmation of protocol-eligibility and informed consent, investigators will
      provide all patients with a large-screen smartphone (unless the patient owns their own
      compatible large-screen smartphone) with a symptoms diary app, and GPS tracking features
      pre-installed; this will allow investigators to track pain and mood as well as any opioid or
      non-opioid pain treatments used by patients, and steps traveled.

      Patients enrolled in the CALM-SCD group will complete at least 4 1-hour cCBT sessions over 3
      months using their personal or study-provided smartphone. Because cCBT programs are less
      effective without a human support component, participants will also be introduced to a care
      coach (master's level student tech who will receive training in CBT) who will contact them on
      a weekly basis by phone/text for up to 3 months. The care coach will reinforce CBT materials
      and encourage engagement. Participants will have continued access to the program after first
      3 months, but care coach support will only be available on an as-needed basis.

      Patients enrolled in the eEducation group will receive pain education through online modules
      that they will be asked to complete using their study-provided smartphone. Each module
      includes learning tasks, a reading assignment, and a short quiz based on material. The
      education group will receive care coach contact on the same schedule as the cCBT group. The
      care coach will provide supportive therapy and encouragement to complete modules and apply
      the lessons to their daily life.

      Patients who are not eligible or who are not randomized into one of the intervention arms of
      this study will serve as a comparison group to ensure we are treating a representative sample
      of patients. Further, patients who were eligible but were not randomized into one of the
      intervention arms will serve as a usual care control group.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Three-arm feasibility trial
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability of cognitive behavioral therapy trial for participants
time frame: 6 months
description: Number of cCBT sessions completed
measure: Feasibility of recruitment and enrollment into cognitive behavioral therapy trial
time frame: 3-6 months of open enrollment
description: Number of patients enrolled / number of patients screened and approached
measure: Pain intensity
time frame: 1, 3, 6, and 12 months
description: Average change in 0-10 VAS pain intensity over course of study
measure: Pain interference
time frame: 1, 3, 6, and 12 months
description: PROMIS Pain Interference
measure: Depressive symptoms
time frame: 1, 3, 6, and 12 months
description: PHQ-9 depression measure
measure: Anxiety symptoms
time frame: 1, 3, 6, and 12 months
description: GAD-7 anxiety scale
measure: Pain Catastrophizing Scale
time frame: 1, 3, 6, and 12 months
description: Pain Catastrophizing
measure: Sickle Cell Self-efficacy Scale
time frame: 1, 3, 6, and 12 months
description: Self-efficacy
measure: ASCQ-Me
time frame: 1, 3, 6, and 12 months
description: Quality of life measures
measure: Activity space
time frame: 6 months
description: GPS activity tracking on the smartphone
arm group label: Computerized CBT
arm group type: Experimental
description: Computerized cognitive behavioral therapy (cCBT) for pain via an integrated smartphone and web-based skills training program: The training plan will help users learn 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; thus, the program involves regular homework assignments, and follow-up with the care coach and social network about issues faced and what skills were or could be used. 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: e-Education
arm group type: Active Comparator
description: Participants will receive pain education through online modules that they will be asked to complete using their personal or study-provided smartphone. Each module includes learning tasks, a reading assignment, and a short quiz based on material. The education group will receive care coach contact on the same schedule as the cCBT group. The care coach will provide supportive therapy and encouragement to complete modules and apply the lessons to their daily life.
arm group label: Usual Care
arm group type: No Intervention
description: Participants who are not eligible or who are not randomized into one of the intervention arms of this study will serve as a comparison group to ensure we are treating a representative sample of patients. Further, patients who were eligible but were not randomized into one of the intervention arms will serve as a usual care control group.
intervention type: Behavioral
intervention name: cognitive behavioral therapy
description: CBT teaches 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.
arm group label: Computerized CBT
intervention type: Behavioral
intervention name: eEducation
description: Pain and sickle cell disease education delivered through a mobile electronic device
arm group label: e-Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charles Jonassaint, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Charles Jonassaint
investigator title: PhD
mesh term: Anemia, Sickle Cell
mesh term: Chronic Pain
sharing ipd: Undecided
ipd description: A public-use data set (PUD) will be available through our study website. The PUD will be a cleaned, de-identified copy that includes all enrolled participants. Sensitive, identifying, unreliable, or invalid data will be excluded.
Researchers may request a copy of the PUD electronically from the Clinical Research Services at the University of Pittsburgh, conditional upon receiving IRB approval for a research proposal from their home institution.