<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/NCT03800654</url>
  </required_header>
  <id_info>
    <org_study_id>D2807-W</org_study_id>
    <secondary_id>RX002807</secondary_id>
    <nct_id>NCT03800654</nct_id>
  </id_info>
  <brief_title>Mindful Action for Pain</brief_title>
  <acronym>MAP</acronym>
  <official_title>Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function</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>Yes</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>
      An emerging scientific model that has been applied to chronic pain is the psychological&#xD;
      flexibility (PF) model. PF refers to the ability to behave consistently with one's values&#xD;
      even in the face of unwanted thoughts, feelings, and bodily sensations such as pain.&#xD;
      Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model&#xD;
      and is as effective as the gold standard Cognitive Behavioral Therapy (CBT), but falls short&#xD;
      on achieving meaningful changes in functional improvement. Although ACT was designed to&#xD;
      impact PF, methods from different treatment approaches are also consistent with the model. An&#xD;
      experiential strategy that holds promise for enhancing PF is formal mindfulness meditation, a&#xD;
      practice used to train non-judgmental awareness and attention to present-moment experiences,&#xD;
      which has never been tested within the PF model. There is compelling theoretical and&#xD;
      empirical rationale that the mechanisms underlying formal mindfulness meditation will bolster&#xD;
      PF processes and thereby can be applied to facilitate functional improvement. To test this,&#xD;
      the principal investigator, has developed a novel 8-week group-based intervention, Mindful&#xD;
      Action for Pain (MAP), which integrates formal mindfulness meditation with experiential&#xD;
      methods from different evidence-based treatment approaches in accordance with the PF model.&#xD;
      MAP is designed such that daily mindfulness meditation practice is used to develop the&#xD;
      capacity to more completely utilize strategies to address the key psychosocial barriers&#xD;
      (e.g., pain catastrophizing) to optimal functioning.&#xD;
&#xD;
      This CDA-2 project consists of two phases. Phase 1 (years 1 - 2) consists of using&#xD;
      qualitative and quantitative methods to iteratively develop and refine MAP over the course of&#xD;
      4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot RCT (n = 86) of MAP vs. CBT&#xD;
      for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and&#xD;
      estimate the preliminary impact of MAP. Functional improvement will be measured by reductions&#xD;
      in pain interference (primary clinical outcome). Further, meditation adherence will be&#xD;
      assessed to explore dose-response relationships with functional improvement, and objective&#xD;
      measures of physical activity (actigraphy) will be captured to explore the psychophysical&#xD;
      impact of MAP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pain, defined as persistent or episodic pain that does not resolve with treatment,&#xD;
      affects up to 50% of Veterans, costs the nation between $560 and $635 billion dollars&#xD;
      annually, and is associated with high rates of disability and low quality of life. According&#xD;
      to the Veterans Health Administration (VHA), the goal of pain treatment is to improve&#xD;
      physical and psychosocial functioning, emphasizing non-pharmacological approaches, such as&#xD;
      psychosocial interventions, to target psychosocial factors that maintain disability.&#xD;
      Unfortunately, the gold standard psychosocial intervention for chronic pain, Cognitive&#xD;
      Behavioral Therapy (CBT), does not reliably produce meaningful increases in function.&#xD;
&#xD;
      An emerging scientific model that has been applied to chronic pain is the psychological&#xD;
      flexibility (PF) model. PF refers to the ability to behave consistently with one's values&#xD;
      even in the face of unwanted thoughts, feelings, and bodily sensations such as pain.&#xD;
      Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model&#xD;
      and is as effective as the gold standard CBT, but still falls short on achieving meaningful&#xD;
      changes in functional improvement. Although ACT was designed to impact PF, methods from&#xD;
      different treatment approaches are also consistent with the model. An experiential strategy&#xD;
      that holds promise for enhancing PF is formal mindfulness meditation, a practice used to&#xD;
      train non-judgmental awareness and attention to present-moment experiences, which has never&#xD;
      been tested within the PF model. There is compelling theoretical and empirical rationale that&#xD;
      the mechanisms underlying formal mindfulness meditation will bolster PF processes and thereby&#xD;
      can be applied to facilitate functional improvement. To test this, the principal&#xD;
      investigator, has developed a novel 8-week group-based intervention, Mindful Action for Pain&#xD;
      (MAP), which integrates formal mindfulness meditation with experiential methods from&#xD;
      different evidence-based treatment approaches in accordance with the PF model. MAP is&#xD;
      designed such that daily mindfulness meditation practice is used to develop the capacity to&#xD;
      more completely utilize strategies to address the key psychosocial barriers (e.g., pain&#xD;
      catastrophizing) to optimal functioning.&#xD;
&#xD;
      This CDA-2 project consists of two phases. Phase 1 (years 1 - 2) consists of using&#xD;
      qualitative and quantitative methods to iteratively develop and refine MAP over the course of&#xD;
      4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot RCT (n = 86) of MAP vs. CBT&#xD;
      for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and&#xD;
      estimate the preliminary impact of MAP. Functional improvement will be measured by reductions&#xD;
      in pain interference (primary clinical outcome). Further, meditation adherence will be&#xD;
      assessed to explore dose-response relationships with functional improvement, and objective&#xD;
      measures of physical activity (actigraphy) will be captured to explore the psychophysical&#xD;
      impact of MAP.&#xD;
&#xD;
      Aim 1: Fully develop MAP in a population of Veterans with chronic pain (Phase 1).&#xD;
&#xD;
      Aim 2: Evaluate the feasibility of a future randomized efficacy trial of MAP vs. CBT-CP&#xD;
      (Phase 2).&#xD;
&#xD;
      Hypothesis 1: MAP and CBT-CP will be feasible to deliver, as evidenced by attainment of&#xD;
      recruitment goals, retention rates &gt; 80%, and high credibility and expectancy ratings.&#xD;
&#xD;
      Aim 3: Estimate the preliminary impact of MAP and CBT-CP to determine if a future efficacy&#xD;
      trial is warranted.&#xD;
&#xD;
      Examine changes in pain interference (a proxy for functional improvement and one of the most&#xD;
      commonly measured outcomes in psychosocial intervention trials of chronic pain), pain&#xD;
      acceptance, trait mindfulness, and pain catastrophizing, as well as patient satisfaction&#xD;
      ratings, as indicators that MAP may be worthy of investigation in a future large-scale trial.&#xD;
&#xD;
      Exploratory Aim 1: Explore the relationship between meditation adherence and treatment&#xD;
      outcomes.&#xD;
&#xD;
      There is growing evidence for a dose-response relationship between meditation practice and&#xD;
      positive outcomes. Therefore, strategies to increase meditation adherence will be optimized&#xD;
      (Phase 1) and the relationship between adherence as measured via daily diaries and outcomes&#xD;
      will be assessed (Phase 2).&#xD;
&#xD;
      Exploratory Aim 2: Explore objective measures of physical activity at baseline and&#xD;
      post-intervention as a potential future index of functional outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 28, 2019</start_date>
  <completion_date type="Anticipated">March 29, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 29, 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>Group Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Pain Inventory (BPI) Pain Interference Subscale Change</measure>
    <time_frame>Baseline, weekly during treatment (i.e., weeks 1 - 8), and week 9</time_frame>
    <description>The BPI Pain Interference subscale consists of 7-items rated on a 0 - 10 scale that measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Higher scores indicate higher levels of pain interference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chronic Pain Acceptance Questionnaire (CPAQ)</measure>
    <time_frame>Baseline and week 9</time_frame>
    <description>The CPAQ consists of 20-items rated on a 0 - 6 scale that measures the degree that patients have adjusted to pain as part of their identity and lifestyle. Higher scores indicate higher levels of pain acceptance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five-Factor Mindfulness Questionnaire (FFMQ)</measure>
    <time_frame>Baseline and week 9</time_frame>
    <description>The FFMQ measure five facets of mindfulness: observing inner experience, describing experience, acting with awareness, non-judging of experience, and non-reactivity to inner experience. The FFMQ consists of 39-items rated on a 1 - 5 scale with higher scores indicating greater mindfulness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>Baseline and week 9</time_frame>
    <description>The PCS consists of 13 items rated on 0 - 4 scale that measures the degree to which people experience an aversive orientation towards pain. Higher scores indicate higher levels of pain catastrophizing.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Meditation diaries</measure>
    <time_frame>Weekly during treatment (i.e., weeks 1 - 8) and week 9</time_frame>
    <description>On these diaries, participants report the duration of meditation practice and what kind of practice (e.g., breathing, body scan).</description>
  </other_outcome>
  <other_outcome>
    <measure>Actigraphy</measure>
    <time_frame>Baseline and week 9</time_frame>
    <description>Participants will wear actiwatches for two 7-day periods at baseline and week 9 to measure average physical activity counts.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Mindful Action for Pain (MAP) Development</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the first arm, MAP will be fully developed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MAP vs. CBT-CP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the second arm, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindful Action for Pain</intervention_name>
    <description>MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.</description>
    <arm_group_label>MAP vs. CBT-CP</arm_group_label>
    <arm_group_label>Mindful Action for Pain (MAP) Development</arm_group_label>
    <other_name>MAP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Chronic Pain</intervention_name>
    <description>CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.</description>
    <arm_group_label>MAP vs. CBT-CP</arm_group_label>
    <other_name>CBT-CP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veteran&#xD;
&#xD;
          -  Diagnosis of a chronic, non-terminal pain condition&#xD;
&#xD;
          -  Pain most days (&gt; 3 days/week) for at least 6 months&#xD;
&#xD;
          -  Average pain severity and interference with enjoyment of life and/or general activity&#xD;
             rated &gt; 4/10 over the past week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious or unstable medical or psychiatric illness&#xD;
&#xD;
               -  (e.g., unmanaged psychosis, manic episode, or substance abuse within the past&#xD;
                  year) or psychosocial instability&#xD;
&#xD;
               -  (e.g., homelessness) that could compromise study participation&#xD;
&#xD;
          -  Active suicidal ideation or history of suicide attempt within past 3 years&#xD;
&#xD;
          -  Current participation in group psychotherapy for pain or any type of individual&#xD;
             psychotherapy&#xD;
&#xD;
          -  Changes to professionally delivered pain or mood treatments&#xD;
&#xD;
               -  (e.g., no discontinuation of a treatment; no increasing the dose of medication)&#xD;
                  one month preceding the baseline assessment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Herbert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA San Diego Healthcare System, San Diego, CA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer S Salamat, BS</last_name>
    <phone>(858) 552-8585</phone>
    <phone_ext>5596</phone_ext>
    <email>jennifer.salamat@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthew Herbert, PhD</last_name>
    <phone>(858) 642-3944</phone>
    <email>matthew.herbert2@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA San Diego Healthcare System, San Diego, CA</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161-0002</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Niloofar Afari, PhD</last_name>
      <phone>619-400-5016</phone>
      <email>Niloofar.Afari@va.gov</email>
    </contact>
    <investigator>
      <last_name>Matthew Herbert, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Pain</keyword>
  <keyword>Psychological Flexibility</keyword>
  <keyword>Mindfulness Meditation</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>A data repository will be created upon completion of the study. Data obtained in this study that has scientific value to other qualified researchers will made available upon request. Interested researches will be able to access de-identified data through a Data Use Agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Indefinitely</ipd_time_frame>
    <ipd_access_criteria>February, 2024</ipd_access_criteria>
  </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/NCT03800654
org study id: D2807-W
secondary id: RX002807
nct id: NCT03800654
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
An emerging scientific model that has been applied to chronic pain is the psychological
      flexibility (PF) model. PF refers to the ability to behave consistently with one's values
      even in the face of unwanted thoughts, feelings, and bodily sensations such as pain.
      Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model
      and is as effective as the gold standard Cognitive Behavioral Therapy (CBT), but falls short
      on achieving meaningful changes in functional improvement. Although ACT was designed to
      impact PF, methods from different treatment approaches are also consistent with the model. An
      experiential strategy that holds promise for enhancing PF is formal mindfulness meditation, a
      practice used to train non-judgmental awareness and attention to present-moment experiences,
      which has never been tested within the PF model. There is compelling theoretical and
      empirical rationale that the mechanisms underlying formal mindfulness meditation will bolster
      PF processes and thereby can be applied to facilitate functional improvement. To test this,
      the principal investigator, has developed a novel 8-week group-based intervention, Mindful
      Action for Pain (MAP), which integrates formal mindfulness meditation with experiential
      methods from different evidence-based treatment approaches in accordance with the PF model.
      MAP is designed such that daily mindfulness meditation practice is used to develop the
      capacity to more completely utilize strategies to address the key psychosocial barriers
      (e.g., pain catastrophizing) to optimal functioning.

      This CDA-2 project consists of two phases. Phase 1 (years 1 - 2) consists of using
      qualitative and quantitative methods to iteratively develop and refine MAP over the course of
      4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot RCT (n = 86) of MAP vs. CBT
      for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and
      estimate the preliminary impact of MAP. Functional improvement will be measured by reductions
      in pain interference (primary clinical outcome). Further, meditation adherence will be
      assessed to explore dose-response relationships with functional improvement, and objective
      measures of physical activity (actigraphy) will be captured to explore the psychophysical
      impact of MAP.
Chronic pain, defined as persistent or episodic pain that does not resolve with treatment,
      affects up to 50% of Veterans, costs the nation between $560 and $635 billion dollars
      annually, and is associated with high rates of disability and low quality of life. According
      to the Veterans Health Administration (VHA), the goal of pain treatment is to improve
      physical and psychosocial functioning, emphasizing non-pharmacological approaches, such as
      psychosocial interventions, to target psychosocial factors that maintain disability.
      Unfortunately, the gold standard psychosocial intervention for chronic pain, Cognitive
      Behavioral Therapy (CBT), does not reliably produce meaningful increases in function.

      An emerging scientific model that has been applied to chronic pain is the psychological
      flexibility (PF) model. PF refers to the ability to behave consistently with one's values
      even in the face of unwanted thoughts, feelings, and bodily sensations such as pain.
      Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model
      and is as effective as the gold standard CBT, but still falls short on achieving meaningful
      changes in functional improvement. Although ACT was designed to impact PF, methods from
      different treatment approaches are also consistent with the model. An experiential strategy
      that holds promise for enhancing PF is formal mindfulness meditation, a practice used to
      train non-judgmental awareness and attention to present-moment experiences, which has never
      been tested within the PF model. There is compelling theoretical and empirical rationale that
      the mechanisms underlying formal mindfulness meditation will bolster PF processes and thereby
      can be applied to facilitate functional improvement. To test this, the principal
      investigator, has developed a novel 8-week group-based intervention, Mindful Action for Pain
      (MAP), which integrates formal mindfulness meditation with experiential methods from
      different evidence-based treatment approaches in accordance with the PF model. MAP is
      designed such that daily mindfulness meditation practice is used to develop the capacity to
      more completely utilize strategies to address the key psychosocial barriers (e.g., pain
      catastrophizing) to optimal functioning.

      This CDA-2 project consists of two phases. Phase 1 (years 1 - 2) consists of using
      qualitative and quantitative methods to iteratively develop and refine MAP over the course of
      4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot RCT (n = 86) of MAP vs. CBT
      for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and
      estimate the preliminary impact of MAP. Functional improvement will be measured by reductions
      in pain interference (primary clinical outcome). Further, meditation adherence will be
      assessed to explore dose-response relationships with functional improvement, and objective
      measures of physical activity (actigraphy) will be captured to explore the psychophysical
      impact of MAP.

      Aim 1: Fully develop MAP in a population of Veterans with chronic pain (Phase 1).

      Aim 2: Evaluate the feasibility of a future randomized efficacy trial of MAP vs. CBT-CP
      (Phase 2).

      Hypothesis 1: MAP and CBT-CP will be feasible to deliver, as evidenced by attainment of
      recruitment goals, retention rates > 80%, and high credibility and expectancy ratings.

      Aim 3: Estimate the preliminary impact of MAP and CBT-CP to determine if a future efficacy
      trial is warranted.

      Examine changes in pain interference (a proxy for functional improvement and one of the most
      commonly measured outcomes in psychosocial intervention trials of chronic pain), pain
      acceptance, trait mindfulness, and pain catastrophizing, as well as patient satisfaction
      ratings, as indicators that MAP may be worthy of investigation in a future large-scale trial.

      Exploratory Aim 1: Explore the relationship between meditation adherence and treatment
      outcomes.

      There is growing evidence for a dose-response relationship between meditation practice and
      positive outcomes. Therefore, strategies to increase meditation adherence will be optimized
      (Phase 1) and the relationship between adherence as measured via daily diaries and outcomes
      will be assessed (Phase 2).

      Exploratory Aim 2: Explore objective measures of physical activity at baseline and
      post-intervention as a potential future index of functional outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group Randomized Controlled Trial
primary purpose: Treatment
masking: Single (Participant)
measure: Brief Pain Inventory (BPI) Pain Interference Subscale Change
time frame: Baseline, weekly during treatment (i.e., weeks 1 - 8), and week 9
description: The BPI Pain Interference subscale consists of 7-items rated on a 0 - 10 scale that measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Higher scores indicate higher levels of pain interference.
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
time frame: Baseline and week 9
description: The CPAQ consists of 20-items rated on a 0 - 6 scale that measures the degree that patients have adjusted to pain as part of their identity and lifestyle. Higher scores indicate higher levels of pain acceptance.
measure: Five-Factor Mindfulness Questionnaire (FFMQ)
time frame: Baseline and week 9
description: The FFMQ measure five facets of mindfulness: observing inner experience, describing experience, acting with awareness, non-judging of experience, and non-reactivity to inner experience. The FFMQ consists of 39-items rated on a 1 - 5 scale with higher scores indicating greater mindfulness.
measure: Pain Catastrophizing Scale (PCS)
time frame: Baseline and week 9
description: The PCS consists of 13 items rated on 0 - 4 scale that measures the degree to which people experience an aversive orientation towards pain. Higher scores indicate higher levels of pain catastrophizing.
measure: Meditation diaries
time frame: Weekly during treatment (i.e., weeks 1 - 8) and week 9
description: On these diaries, participants report the duration of meditation practice and what kind of practice (e.g., breathing, body scan).
measure: Actigraphy
time frame: Baseline and week 9
description: Participants will wear actiwatches for two 7-day periods at baseline and week 9 to measure average physical activity counts.
arm group label: Mindful Action for Pain (MAP) Development
arm group type: Other
description: In the first arm, MAP will be fully developed.
arm group label: MAP vs. CBT-CP
arm group type: Active Comparator
description: In the second arm, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
intervention type: Behavioral
intervention name: Mindful Action for Pain
description: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.
arm group label: MAP vs. CBT-CP
arm group label: Mindful Action for Pain (MAP) Development
other name: MAP
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Chronic Pain
description: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
arm group label: MAP vs. CBT-CP
other name: CBT-CP
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Matthew Herbert, PhD
role: Principal Investigator
affiliation: VA San Diego Healthcare System, San Diego, CA
last name: Jennifer S Salamat, BS
phone: (858) 552-8585
phone ext: 5596
email: jennifer.salamat@va.gov
last name: Matthew Herbert, PhD
phone: (858) 642-3944
email: matthew.herbert2@va.gov
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: Yes
ipd description: A data repository will be created upon completion of the study. Data obtained in this study that has scientific value to other qualified researchers will made available upon request. Interested researches will be able to access de-identified data through a Data Use Agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Indefinitely
ipd access criteria: February, 2024