xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06001814</url>
    </required_header>
    <id_info>
      <org_study_id>2023P002014</org_study_id>
      <secondary_id>1K23HL167650-01A1</secondary_id>
      <nct_id>NCT06001814</nct_id>
    </id_info>
    <brief_title>Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV</brief_title>
    <acronym>OM-OH</acronym>
    <official_title>Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts General Hospital</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>
        Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD)&#xD;
        attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting&#xD;
        inflammation. Systemic inflammation is exacerbated by psychological distress via activating&#xD;
        the immune response and driving pro-inflammatory CVD risk behaviors. There is promising&#xD;
        evidence to suggest that mindfulness could be an effective intervention to reduce&#xD;
        psychological distress and support behaviorally- and inflammatory-mediated CVD risk&#xD;
        reduction. This project aims to refine and synthesize mindfulness and behavior change content&#xD;
        from evidence-based protocols (mindfulness-based stress reduction and diabetes prevention&#xD;
        program) to develop and pilot test a new text message-enhanced intervention called &quot;One Mind&#xD;
        One Heart&quot; (OM-OH) using feedback from semi-structured interviews with OPWH in psychological&#xD;
        distress (N=20), and my multidisciplinary mentorship team (Aim 1). An open pilot (N=5) with&#xD;
        exit interviews and pre-post self-report assessments, will inform the initial acceptability&#xD;
        of OM-OH and further refine OM-OH as needed (Aim 2). Finally, a pilot randomized controlled&#xD;
        trial (RCT; N=50) will be conducted to a.) evaluate benchmarks of feasibility and&#xD;
        acceptability of study methods and refined OM-OH compared to enhanced usual care, and b.)&#xD;
        investigate potential for effects on psychological distress, inflammation, and behavioral CVD&#xD;
        risk (Aim 3). Findings will provide the foundation for an R01 application to conduct an&#xD;
        efficacy trial of OM-OH to reduce inflammatory-mediated CVD risk among OPWH.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2027</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of recruitment</measure>
      <time_frame>Baseline (pre-intervention)</time_frame>
      <description>70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of eligibility criteria</measure>
      <time_frame>Baseline (pre-intervention)</time_frame>
      <description>Less than 20% of participants are ineligible due to each criterion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of randomization</measure>
      <time_frame>Pre-intervention</time_frame>
      <description>70% or more of participants are randomized and complete the first intervention session</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of the OM-OM intervention</measure>
      <time_frame>Duration of intervention</time_frame>
      <description>70% or more of participants attend all sessions and complete all homework</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of research assessments</measure>
      <time_frame>Duration of intervention; 0 and 12-week follow-up</time_frame>
      <description>70% or more of weekly and follow-up research assessments are completed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of blood draws</measure>
      <time_frame>Baseline; 12-week follow-up</time_frame>
      <description>70% of more are collected</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of OM-OH intervention</measure>
      <time_frame>0-weeks post-intervention</time_frame>
      <description>Rating of 7.5 or greater/10 on: session satisfaction, helpfulness, and utility; overall program satisfaction; plan to use the skills; and would recommend the intervention program to a friend</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of text-enhanced delivery</measure>
      <time_frame>0-weeks post-intervention</time_frame>
      <description>Rating of 7.5 or greater/10 on: ease, and confidence of use; and rating of 2 or less/10 on interference of technical problems</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of blood draws</measure>
      <time_frame>0- and 12-weeks post-intervention</time_frame>
      <description>Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Five Factor Mindfulness Questionnaire (FFMQ)</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>The FFQ assesses trait mindfulness.There are five sub scales: observing, describing, acting with awareness, non-judging, and non-reactivity. The FFMQ sub scale summary scores can be calculated by dividing the total in each category by the number of items in that category. The FFMQ sum score can be divided by 39 to get an average item score. Higher scores indicated greater trait mindfulness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire - 9 (PHQ-9)</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>PHQ-9 assesses depressive symptoms. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depressive symptoms, respectively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder - 7 (GAD-7)</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>GAD-7 assesses anxiety symptoms. Total scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety symptoms, respectively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale (PSS)</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>The PSS assessed perceived stress. Scores on the PSS range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HIV/AIDS Stress Scale</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>The HIV/AIDS Stress Scale assesses HIV-related stress. The total score ranges from 0-68, with higher scores indicating higher levels of HIV-related stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Alcohol Use Disorder Identification Test - Concise (AUDIT-C)</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive for hazardous drinking; in women, a score of 3 or more is considered positive for hazardous drinking. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity and Sedentary Behavior Questionnaire (PASBQ)</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>The PASBQ assesses frequency and time spent in physical activity and sedentary behaviors. These time will be compared to Centers for Disease Control and Prevention (CDC) to determine if current guidelines are being met (yes/no) for 150 minutes of moderate aerobic activity (or 75 minutes of vigorous aerobic activity) and 2 or more days of muscle strengthening activities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary Risk Assessment (DRA)</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>The DRA assesses dietary patterns. A total DRA score and 4 subscales (Nuts, Oils, Dressings, and Spreads; Vegetables, Fruit, Whole Grains, and Beans; Drinks, Desserts, Snacks, Eating Out, and Salt; and Fish, Meat, Poultry, Dairy, and Eggs) can be derived. Subscales are scored independently by assigning score values accordingly: 2 for response choices in the &quot;Desirable&quot; column; 1 for response choices in the &quot;Could be improved&quot; column; and 0 for response choices in the &quot;Needs to be improved&quot; column. Sum the 4 subscales to obtain a total DRA score ranging 0 to 46. For all scoring, a higher score represents a more healthful dietary pattern.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fagerstrom Test For Nicotine Dependence (FTND)</measure>
      <time_frame>0 and 12-weeks post-intervention</time_frame>
      <description>The FTND assesses dependence on nicotine. Scores for all item are summed. Scores of �1-2: low dependence; 3-4 low to moderate dependence; 5-7 moderate dependence; 8+ high dependence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inflammation Biomarkers</measure>
      <time_frame>0- and 12-weeks post-intervention</time_frame>
      <description>Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Hiv</condition>
    <condition>Cardiovascular Diseases</condition>
    <arm_group>
      <arm_group_label>One-Mind One-Heart</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One-Mind One-Heart (OM-OH) is intended to be a mindfulness-based, behavior change intervention to reduce psychological and behavioral cardiovascular disease risk.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Education</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The education session will provide information on behaviors important for cardiovascular disease risk reduction.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>One-Mind One-Heart</intervention_name>
      <description>One-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use.</description>
      <arm_group_label>One-Mind One-Heart</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education</intervention_name>
      <description>Education will be provided on behavioral cardiovascular disease risk reduction strategies, such as increasing physical activity, reducing salt intake in diet, and reduce/stop alcohol and tobacco-use.</description>
      <arm_group_label>Education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. age ≥50 years&#xD;
  &#xD;
            2. clinical diagnosis of HIV per medical record or provision of current antiretroviral&#xD;
               medication prescription&#xD;
  &#xD;
            3. viral suppression - i.e., lower than detectable limit - per medical record or&#xD;
               provision of viral load test from the past six months&#xD;
  &#xD;
            4. current elevated psychological distress (score ≥10 on 10-item Kessler Psychological&#xD;
               Distress Scale [K10]) screener)&#xD;
  &#xD;
            5. ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score&#xD;
               Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol&#xD;
  &#xD;
            6. access to cell phone with text messaging capabilities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. non-English-speaking&#xD;
  &#xD;
            2. cognitive impairments preventing informed consent&#xD;
  &#xD;
            3. untreated or under-treated serious mental illness (i.e., psychosis and bipolar&#xD;
               disorder) based on clinical interview&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jacklyn Foley, PhD</last_name>
      <phone>857-347-5312</phone>
      <email>jdfoley@mgh.harvard.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Jacklyn D. Foley, Ph.D</investigator_full_name>
      <investigator_title>Psychologist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>We plan to share aggregated data only.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06001814
  org study id: 2023P002014
  secondary id: 1K23HL167650-01A1
  nct id: NCT06001814
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD)
        attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting
        inflammation. Systemic inflammation is exacerbated by psychological distress via activating
        the immune response and driving pro-inflammatory CVD risk behaviors. There is promising
        evidence to suggest that mindfulness could be an effective intervention to reduce
        psychological distress and support behaviorally- and inflammatory-mediated CVD risk
        reduction. This project aims to refine and synthesize mindfulness and behavior change content
        from evidence-based protocols (mindfulness-based stress reduction and diabetes prevention
        program) to develop and pilot test a new text message-enhanced intervention called "One Mind
        One Heart" (OM-OH) using feedback from semi-structured interviews with OPWH in psychological
        distress (N=20), and my multidisciplinary mentorship team (Aim 1). An open pilot (N=5) with
        exit interviews and pre-post self-report assessments, will inform the initial acceptability
        of OM-OH and further refine OM-OH as needed (Aim 2). Finally, a pilot randomized controlled
        trial (RCT; N=50) will be conducted to a.) evaluate benchmarks of feasibility and
        acceptability of study methods and refined OM-OH compared to enhanced usual care, and b.)
        investigate potential for effects on psychological distress, inflammation, and behavioral CVD
        risk (Aim 3). Findings will provide the foundation for an R01 application to conduct an
        efficacy trial of OM-OH to reduce inflammatory-mediated CVD risk among OPWH.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Feasibility of recruitment
  time frame: Baseline (pre-intervention)
  description: 70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study
  measure: Feasibility of eligibility criteria
  time frame: Baseline (pre-intervention)
  description: Less than 20% of participants are ineligible due to each criterion
  measure: Feasibility of randomization
  time frame: Pre-intervention
  description: 70% or more of participants are randomized and complete the first intervention session
  measure: Feasibility of the OM-OM intervention
  time frame: Duration of intervention
  description: 70% or more of participants attend all sessions and complete all homework
  measure: Feasibility of research assessments
  time frame: Duration of intervention; 0 and 12-week follow-up
  description: 70% or more of weekly and follow-up research assessments are completed
  measure: Feasibility of blood draws
  time frame: Baseline; 12-week follow-up
  description: 70% of more are collected
  measure: Acceptability of OM-OH intervention
  time frame: 0-weeks post-intervention
  description: Rating of 7.5 or greater/10 on: session satisfaction, helpfulness, and utility; overall program satisfaction; plan to use the skills; and would recommend the intervention program to a friend
  measure: Acceptability of text-enhanced delivery
  time frame: 0-weeks post-intervention
  description: Rating of 7.5 or greater/10 on: ease, and confidence of use; and rating of 2 or less/10 on interference of technical problems
  measure: Acceptability of blood draws
  time frame: 0- and 12-weeks post-intervention
  description: Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain
  measure: Five Factor Mindfulness Questionnaire (FFMQ)
  time frame: 0 and 12-weeks post-intervention
  description: The FFQ assesses trait mindfulness.There are five sub scales: observing, describing, acting with awareness, non-judging, and non-reactivity. The FFMQ sub scale summary scores can be calculated by dividing the total in each category by the number of items in that category. The FFMQ sum score can be divided by 39 to get an average item score. Higher scores indicated greater trait mindfulness.
  measure: Patient Health Questionnaire - 9 (PHQ-9)
  time frame: 0 and 12-weeks post-intervention
  description: PHQ-9 assesses depressive symptoms. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depressive symptoms, respectively.
  measure: Generalized Anxiety Disorder - 7 (GAD-7)
  time frame: 0 and 12-weeks post-intervention
  description: GAD-7 assesses anxiety symptoms. Total scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety symptoms, respectively.
  measure: Perceived Stress Scale (PSS)
  time frame: 0 and 12-weeks post-intervention
  description: The PSS assessed perceived stress. Scores on the PSS range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
  measure: HIV/AIDS Stress Scale
  time frame: 0 and 12-weeks post-intervention
  description: The HIV/AIDS Stress Scale assesses HIV-related stress. The total score ranges from 0-68, with higher scores indicating higher levels of HIV-related stress.
  measure: Alcohol Use Disorder Identification Test - Concise (AUDIT-C)
  time frame: 0 and 12-weeks post-intervention
  description: The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive for hazardous drinking; in women, a score of 3 or more is considered positive for hazardous drinking. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
  measure: Physical Activity and Sedentary Behavior Questionnaire (PASBQ)
  time frame: 0 and 12-weeks post-intervention
  description: The PASBQ assesses frequency and time spent in physical activity and sedentary behaviors. These time will be compared to Centers for Disease Control and Prevention (CDC) to determine if current guidelines are being met (yes/no) for 150 minutes of moderate aerobic activity (or 75 minutes of vigorous aerobic activity) and 2 or more days of muscle strengthening activities.
  measure: Dietary Risk Assessment (DRA)
  time frame: 0 and 12-weeks post-intervention
  description: The DRA assesses dietary patterns. A total DRA score and 4 subscales (Nuts, Oils, Dressings, and Spreads; Vegetables, Fruit, Whole Grains, and Beans; Drinks, Desserts, Snacks, Eating Out, and Salt; and Fish, Meat, Poultry, Dairy, and Eggs) can be derived. Subscales are scored independently by assigning score values accordingly: 2 for response choices in the "Desirable" column; 1 for response choices in the "Could be improved" column; and 0 for response choices in the "Needs to be improved" column. Sum the 4 subscales to obtain a total DRA score ranging 0 to 46. For all scoring, a higher score represents a more healthful dietary pattern.
  measure: Fagerstrom Test For Nicotine Dependence (FTND)
  time frame: 0 and 12-weeks post-intervention
  description: The FTND assesses dependence on nicotine. Scores for all item are summed. Scores of �1-2: low dependence; 3-4 low to moderate dependence; 5-7 moderate dependence; 8+ high dependence.
  measure: Inflammation Biomarkers
  time frame: 0- and 12-weeks post-intervention
  description: Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood
  arm group label: One-Mind One-Heart
  arm group type: Experimental
  description: One-Mind One-Heart (OM-OH) is intended to be a mindfulness-based, behavior change intervention to reduce psychological and behavioral cardiovascular disease risk.
  arm group label: Education
  arm group type: Active Comparator
  description: The education session will provide information on behaviors important for cardiovascular disease risk reduction.
  intervention type: Behavioral
  intervention name: One-Mind One-Heart
  description: One-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use.
  arm group label: One-Mind One-Heart
  intervention type: Other
  intervention name: Education
  description: Education will be provided on behavioral cardiovascular disease risk reduction strategies, such as increasing physical activity, reducing salt intake in diet, and reduce/stop alcohol and tobacco-use.
  arm group label: Education
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jacklyn Foley, PhD
  phone: 857-347-5312
  email: jdfoley@mgh.harvard.edu
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Jacklyn D. Foley, Ph.D
  investigator title: Psychologist
  mesh term: Cardiovascular Diseases
  sharing ipd: No
  ipd description: We plan to share aggregated data only.