<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/NCT04486066</url>
  </required_header>
  <id_info>
    <org_study_id>D3283-R</org_study_id>
    <secondary_id>IO1RX003283-01A2</secondary_id>
    <nct_id>NCT04486066</nct_id>
  </id_info>
  <brief_title>An Evaluation of MBSR and CBT for Veterans With Chronic Pain</brief_title>
  <acronym>IMPROVE</acronym>
  <official_title>An Evaluation of MBSR and CBT for Veterans With Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately fifty percent of Veterans report chronic pain. Management of chronic pain is&#xD;
      often compounded by other life problems, including depression and posttraumatic stress&#xD;
      disorder. Use of opioids for pain management entails risk of harm, and effective&#xD;
      non-pharmacologic approaches to chronic pain management are needed. Mindfulness-Based Stress&#xD;
      Reduction (MBSR) and group Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) are&#xD;
      programs that teach skills to improve functionality and quality of life for people with&#xD;
      chronic pain. However, studies of MBSR and the group form of CBT-CP for chronic pain remain&#xD;
      limited. In the proposed trial, MBSR will be compared to CBT-CP and usual care, with&#xD;
      assessment of pain interference and other outcomes at 6-month follow-up. If MBSR and group&#xD;
      CBT-CP are shown to be effective in improving outcomes, it would support use of these&#xD;
      modalities for chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Pain is one of the most common reasons Veterans seek health care. Mental health&#xD;
      conditions (including PTSD, anxiety, and depression) are estimated to co-occur for 30-50% of&#xD;
      Veterans with chronic pain. Current recommendations for pain management include an&#xD;
      integrative approach informed by the biopsychosocial model. It is increasingly recognized&#xD;
      that use of opioids for pain management is associated with risk of harm, yet treatment&#xD;
      studies of non-pharmacologic approaches remain limited. Mindfulness-Based Stress Reduction&#xD;
      (MBSR) and Cognitive Behavioral Therapy for chronic pain (CBT-CP) teach skills intended to&#xD;
      enhance functionality and quality of life in the face of chronic pain. The proposed&#xD;
      randomized clinical trial will evaluate if MBSR and CBT-CP each result in improvements in&#xD;
      pain interference that are superior to usual care. Two hundred twenty-two Veterans with&#xD;
      chronic musculoskeletal pain will be randomized to MBSR, CBT-CP or usual care. Measures&#xD;
      pertaining to the primary outcome of pain interference will be collected at baseline, at the&#xD;
      post-MBSR/CBT-CP time point, and at 6-month follow-up. In addition, measures of pain&#xD;
      intensity, depression, and treatment satisfaction will be applied to more fully characterize&#xD;
      the impact of MBSR relative to CBT-CP and usual care. Exploratory analyses will assess if&#xD;
      outcomes differ for MBSR and CBT-CP, the impact of the interventions on opioid use and&#xD;
      indicators of suicidality, and whether Veteran characteristics assessed at baseline function&#xD;
      as treatment moderators. Aims: Primary Aim: Assess if MBSR and CBT-CP each result in greater&#xD;
      reductions in the pain interference subscale of the Brief Pain Inventory (BPI) as compared to&#xD;
      usual care, from baseline to 6 months post-treatment. Secondary Aim: Evaluate if MBSR and&#xD;
      CBT-CP are each superior to usual care in producing improvements in pain severity, treatment&#xD;
      satisfaction, and depression. Exploratory Aim 1: Evaluate whether outcomes for patients&#xD;
      randomized to MBSR and CBT-CP differ for changes in pain interference, pain severity,&#xD;
      depression, and treatment satisfaction. Exploratory Aim 2: Evaluate the impact of MBSR and&#xD;
      CBT-CP on utilization of opioid analgesics and markers of suicidality.&#xD;
&#xD;
      Exploratory Aim 3: Evaluate moderators of response to MBSR and CBT-CP to lay the groundwork&#xD;
      for identifying Veterans more likely to succeed in one or the other treatment. Potential&#xD;
      moderators assessed will include: age, gender, baseline depressive symptoms, anxiety&#xD;
      sensitivity, and pain catastrophizing.&#xD;
&#xD;
      Design: A three-arm randomized controlled trial comparing MBSR, CBT-CP and usual care.&#xD;
      Participants: 222 Veterans at a large urban VA facility with chronic musculoskeletal pain.&#xD;
      Interventions: Group MBSR or group CBT-CP, each 8 weeks in duration. Analyses: Mixed models&#xD;
      with assess whether MBSR, CBT-CP each produce greater reductions in outcome variables from&#xD;
      baseline to follow-up compared to usual care. Implications: If MBSR and CBT-CP are each shown&#xD;
      to be superior to usual care for treatment of chronic pain among Veterans, it would support&#xD;
      providing MBSR and CBT-CP for this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 27, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2024</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>Randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Interference Subscale of Brief Pain Inventory (BPI)</measure>
    <time_frame>6 months after completing treatment</time_frame>
    <description>The primary outcome is the Brief Pain Inventory Short Form Interference subscale (BPI). This is a 7-item scale that assesses the extent to which pain interferes with activities in daily life, such as general activity, mood, walking ability, work, relations with other people, sleep, and enjoyment of life.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">222</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Mindfulness-Based Stress Reduction (MBSR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In MBSR, participants meet for 2 hours per week for 8 weeks in a video group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 sessions in a video group format, while retaining all essential elements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-Based Stress Reduction</intervention_name>
    <description>In MBSR, participants meet by video for 2 hours per week for 8 weeks in a group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.</description>
    <arm_group_label>Mindfulness-Based Stress Reduction (MBSR)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Chronic Pain</intervention_name>
    <description>Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 video sessions in a group format, while retaining all essential elements.</description>
    <arm_group_label>Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants must meet criteria for chronic musculoskeletal pain, defined as:&#xD;
&#xD;
          -  musculoskeletal pain of low back&#xD;
&#xD;
          -  cervical spine, or extremities (hip, knee, or shoulder)&#xD;
&#xD;
          -  pain for at least 3 months&#xD;
&#xD;
          -  pain severity (worst or average pain score equal to or greater than 4)(i.e., score of&#xD;
             4 or greater on BPI items 3 or 5) and average pain interference (BPI items 9A-9G)&#xD;
             rated equal to or great than 3 of 10 over prior week, as measured using the Brief Pain&#xD;
             Inventory (BPI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        At baseline, the MINI psychiatric interview will determine psychiatric exclusion criteria:&#xD;
&#xD;
          -  uncontrolled psychotic disorder&#xD;
&#xD;
          -  current bipolar affective disorder with mania&#xD;
&#xD;
          -  current suicidal or homicidal ideation with intent in the last month&#xD;
&#xD;
          -  inpatient psychiatric admission within the past month&#xD;
&#xD;
          -  severe medical conditions that would limit participation (e.g., Class III or IV heart&#xD;
             failure)&#xD;
&#xD;
          -  pending back surgery&#xD;
&#xD;
        Additional exclusion criteria include prior formal participation in MBSR or CBT-CP. The&#xD;
        investigators will include subjects with Alcohol Use Disorder (AUD; defined by the MINI)&#xD;
        but exclude those for whom alcohol use poses a safety threat (defined as current drinking&#xD;
        and a past-year history of alcohol-related seizures or delirium tremens). The investigators&#xD;
        will also include those with Opioid Use Disorder (OUD) and other Substance Use Disorder&#xD;
        (SUD; each defined by the MINI).&#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>Tracy L Simpson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Puget Sound Health Care System Seattle Division, Seattle, WA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tracy L Simpson, PhD</last_name>
    <phone>(206) 277-3337</phone>
    <email>tracy.simpson@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Meghan Storms, MSW</last_name>
    <phone>(206) 277-3594</phone>
    <email>meghan.storms@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System Seattle Division, Seattle, WA</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter J Storm, MHA FACHE</last_name>
      <phone>206-764-2520</phone>
      <email>Peter.Storm@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Amy Marsh</last_name>
      <phone>(206) 764-2670</phone>
      <email>amy.marsh@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>David J. Kearney, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tracy L Simpson, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>December 16, 2022</last_update_submitted>
  <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mindfulness</keyword>
  <keyword>cognitive behavioral therapy</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/NCT04486066
org study id: D3283-R
secondary id: IO1RX003283-01A2
nct id: NCT04486066
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Approximately fifty percent of Veterans report chronic pain. Management of chronic pain is
      often compounded by other life problems, including depression and posttraumatic stress
      disorder. Use of opioids for pain management entails risk of harm, and effective
      non-pharmacologic approaches to chronic pain management are needed. Mindfulness-Based Stress
      Reduction (MBSR) and group Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) are
      programs that teach skills to improve functionality and quality of life for people with
      chronic pain. However, studies of MBSR and the group form of CBT-CP for chronic pain remain
      limited. In the proposed trial, MBSR will be compared to CBT-CP and usual care, with
      assessment of pain interference and other outcomes at 6-month follow-up. If MBSR and group
      CBT-CP are shown to be effective in improving outcomes, it would support use of these
      modalities for chronic pain.
Background: Pain is one of the most common reasons Veterans seek health care. Mental health
      conditions (including PTSD, anxiety, and depression) are estimated to co-occur for 30-50% of
      Veterans with chronic pain. Current recommendations for pain management include an
      integrative approach informed by the biopsychosocial model. It is increasingly recognized
      that use of opioids for pain management is associated with risk of harm, yet treatment
      studies of non-pharmacologic approaches remain limited. Mindfulness-Based Stress Reduction
      (MBSR) and Cognitive Behavioral Therapy for chronic pain (CBT-CP) teach skills intended to
      enhance functionality and quality of life in the face of chronic pain. The proposed
      randomized clinical trial will evaluate if MBSR and CBT-CP each result in improvements in
      pain interference that are superior to usual care. Two hundred twenty-two Veterans with
      chronic musculoskeletal pain will be randomized to MBSR, CBT-CP or usual care. Measures
      pertaining to the primary outcome of pain interference will be collected at baseline, at the
      post-MBSR/CBT-CP time point, and at 6-month follow-up. In addition, measures of pain
      intensity, depression, and treatment satisfaction will be applied to more fully characterize
      the impact of MBSR relative to CBT-CP and usual care. Exploratory analyses will assess if
      outcomes differ for MBSR and CBT-CP, the impact of the interventions on opioid use and
      indicators of suicidality, and whether Veteran characteristics assessed at baseline function
      as treatment moderators. Aims: Primary Aim: Assess if MBSR and CBT-CP each result in greater
      reductions in the pain interference subscale of the Brief Pain Inventory (BPI) as compared to
      usual care, from baseline to 6 months post-treatment. Secondary Aim: Evaluate if MBSR and
      CBT-CP are each superior to usual care in producing improvements in pain severity, treatment
      satisfaction, and depression. Exploratory Aim 1: Evaluate whether outcomes for patients
      randomized to MBSR and CBT-CP differ for changes in pain interference, pain severity,
      depression, and treatment satisfaction. Exploratory Aim 2: Evaluate the impact of MBSR and
      CBT-CP on utilization of opioid analgesics and markers of suicidality.

      Exploratory Aim 3: Evaluate moderators of response to MBSR and CBT-CP to lay the groundwork
      for identifying Veterans more likely to succeed in one or the other treatment. Potential
      moderators assessed will include: age, gender, baseline depressive symptoms, anxiety
      sensitivity, and pain catastrophizing.

      Design: A three-arm randomized controlled trial comparing MBSR, CBT-CP and usual care.
      Participants: 222 Veterans at a large urban VA facility with chronic musculoskeletal pain.
      Interventions: Group MBSR or group CBT-CP, each 8 weeks in duration. Analyses: Mixed models
      with assess whether MBSR, CBT-CP each produce greater reductions in outcome variables from
      baseline to follow-up compared to usual care. Implications: If MBSR and CBT-CP are each shown
      to be superior to usual care for treatment of chronic pain among Veterans, it would support
      providing MBSR and CBT-CP for this population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Interference Subscale of Brief Pain Inventory (BPI)
time frame: 6 months after completing treatment
description: The primary outcome is the Brief Pain Inventory Short Form Interference subscale (BPI). This is a 7-item scale that assesses the extent to which pain interferes with activities in daily life, such as general activity, mood, walking ability, work, relations with other people, sleep, and enjoyment of life.
arm group label: Mindfulness-Based Stress Reduction (MBSR)
arm group type: Experimental
description: In MBSR, participants meet for 2 hours per week for 8 weeks in a video group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
arm group label: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
arm group type: Experimental
description: Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 sessions in a video group format, while retaining all essential elements.
arm group label: Usual Care
arm group type: Other
description: Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
intervention type: Behavioral
intervention name: Mindfulness-Based Stress Reduction
description: In MBSR, participants meet by video for 2 hours per week for 8 weeks in a group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
arm group label: Mindfulness-Based Stress Reduction (MBSR)
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Chronic Pain
description: Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 video sessions in a group format, while retaining all essential elements.
arm group label: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
intervention type: Other
intervention name: Usual Care
description: Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tracy L Simpson, PhD
role: Principal Investigator
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
last name: Tracy L Simpson, PhD
phone: (206) 277-3337
email: tracy.simpson@va.gov
last name: Meghan Storms, MSW
phone: (206) 277-3594
email: meghan.storms@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No