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/NCT05998967</url>
    </required_header>
    <id_info>
      <org_study_id>IVX 23-001</org_study_id>
      <secondary_id>SWIFT-IVI 22-115</secondary_id>
      <nct_id>NCT05998967</nct_id>
    </id_info>
    <brief_title>Pilot Trial of Mobile Mantram Delivery</brief_title>
    <acronym>mMRP</acronym>
    <official_title>Feasibility and Acceptability of Mobile Mantram Repetition Program for Veterans With PTSD (IVI 22-115)</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>
        Mantram Repetition Program (MRP) is a meditation practice that involves silent repetition of&#xD;
        a spiritual word, one-pointed attention, and slowing down. It has been shown to help reduce&#xD;
        PTSD symptoms among Veterans. This study will look at how Veterans reach to learning MRP via&#xD;
        the Internet, either in a self-directed way or with text/phone support.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Easily accessible interventions to address post-traumatic stress disorder (PTSD) can play&#xD;
        critical role in reducing PTSD and associated symptoms in Veterans, especially for those who&#xD;
        remain symptomatic after treatment with other evidence-based interventions, those who prefer&#xD;
        complimentary and integrative therapies, or those who have difficulty accessing traditional&#xD;
        face-to-face mental health services. The value of these programs is their ability to provide&#xD;
        Veterans with more options in their recovery journey and to reach a broad range of Veterans&#xD;
        across multiple settings, including remote rural contexts.&#xD;
  &#xD;
        The Mantram Repetition Program (MRP) is a meditation-based practice that consists of the&#xD;
        repetition of a spiritual word, one-pointed attention, and slowing down. MRP has been shown&#xD;
        to reduce stress in several high-risk populations, and two large randomized, controlled&#xD;
        studies show that MRP reduces PTSD symptoms among Veterans. A brief, web-based, self-directed&#xD;
        version of MRP has been developed to increase the accessibility of evidence-based PTSD&#xD;
        treatment. This version of MRP was tested in a pilot study with undergraduate students,&#xD;
        demonstrating its ease of use and success in getting students to engage with the practice.&#xD;
        The proposed mixed method study will use the Reach, Effectiveness, Adoption, Implementation,&#xD;
        Maintenance (RE-AIM) framework to evaluate the mobile MRP in Veterans with PTSD in two&#xD;
        conditions: self-directed and with text/phone support. Data from this pilot study will inform&#xD;
        the refinement of the MRP delivery strategy and the development of a full-scale trial to test&#xD;
        its effectiveness and implementation outcomes, as well as barriers and facilitators, and&#xD;
        other contextual factors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Actual">September 30, 2022</completion_date>
    <primary_completion_date type="Actual">September 30, 2022</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>Internet-based instruction in MRP in a self-directed or supported manner</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Eligibility rate</measure>
      <time_frame>Day 0</time_frame>
      <description>Rate of eligibility among those screened for participation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Initiation rate</measure>
      <time_frame>Day 1</time_frame>
      <description>Rate of intervention initiation among eligible Veterans</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Completion rate</measure>
      <time_frame>Day 28</time_frame>
      <description>Rate of intervention completion among eligible Veterans</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Credibility</measure>
      <time_frame>Day 1</time_frame>
      <description>Average Veteran perception of the logic, utility and expected benefit of treatment rated on a scale of 0 (not at all) to 8 (very)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Client Satisfaction Questionnaire (CSQ-8)</measure>
      <time_frame>Day 28</time_frame>
      <description>Degree of satisfaction with care received as measured by a CSQ-8 total score. Scores range from 8-32 with higher scores indicating greater satisfaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of Intervention Measure (AIM)</measure>
      <time_frame>Day 28</time_frame>
      <description>Perceived acceptability of the intervention as measured by an AIM average score. Scores range from 1-5 with higher scores indicating greater acceptability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Appropriateness Measure (IAM)</measure>
      <time_frame>Day 28</time_frame>
      <description>Perceived appropriateness of the intervention as measured by an IAM average score. Scores range from 1-5 with higher scores indicating greater appropriateness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Intervention Measure (FIM)</measure>
      <time_frame>Day 28</time_frame>
      <description>Perceived feasibility of the intervention as measured by an FIM average score. Scores range from 1-5 with higher scores indicating greater feasibility.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mantram practice</measure>
      <time_frame>Weeks 2-4</time_frame>
      <description>Frequency of mantram practice in the past week as 0-7 days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PTSD Checklist for DSM-5 (PCL-5)</measure>
      <time_frame>Day 0-28</time_frame>
      <description>Change in PTSD symptoms from baseline to post-treatment as measured by change in the PCL-5 total score. Scores range from 0-80 with higher scores indicating greater PTSD symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire depression items (PHQ-9)</measure>
      <time_frame>Day 0-28</time_frame>
      <description>Change in depression from baseline to post-treatment as measured by change in the PHQ-9 total score. Scores range from 0-27 with higher scores indicating greater depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index</measure>
      <time_frame>Day 0-28</time_frame>
      <description>Change in insomnia from baseline to post-treatment as measured by change in the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">36</enrollment>
    <condition>PTSD</condition>
    <arm_group>
      <arm_group_label>Self-directed MRP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Self-directed instruction in MRP via Internet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Supported MRP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Supported instruction in MRP via Internet</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mobile Mantram Repetition Program</intervention_name>
      <description>Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down</description>
      <arm_group_label>Self-directed MRP</arm_group_label>
      <arm_group_label>Supported MRP</arm_group_label>
      <other_name>mMRP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Veteran&#xD;
  &#xD;
            -  Primary clinical complaint of PTSD&#xD;
  &#xD;
            -  Access to an Internet-enabled device&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cognitive impairment or mental health concerns that necessitated a higher level of&#xD;
               care or interfered with ability to engage in study activities&#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>Ariel J. Lang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA San Diego Healthcare System, San Diego, CA</affiliation>
    </overall_official>
    <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>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 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>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Internet-based care</keyword>
    <keyword>Meditation</keyword>
    <keyword>Feasibility</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 18, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT05998967/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <pending_results>
      <submitted>August 24, 2023</submitted>
    </pending_results>
    <!-- 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/NCT05998967
  org study id: IVX 23-001
  secondary id: SWIFT-IVI 22-115
  nct id: NCT05998967
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Mantram Repetition Program (MRP) is a meditation practice that involves silent repetition of
        a spiritual word, one-pointed attention, and slowing down. It has been shown to help reduce
        PTSD symptoms among Veterans. This study will look at how Veterans reach to learning MRP via
        the Internet, either in a self-directed way or with text/phone support.
  Easily accessible interventions to address post-traumatic stress disorder (PTSD) can play
        critical role in reducing PTSD and associated symptoms in Veterans, especially for those who
        remain symptomatic after treatment with other evidence-based interventions, those who prefer
        complimentary and integrative therapies, or those who have difficulty accessing traditional
        face-to-face mental health services. The value of these programs is their ability to provide
        Veterans with more options in their recovery journey and to reach a broad range of Veterans
        across multiple settings, including remote rural contexts.
  
        The Mantram Repetition Program (MRP) is a meditation-based practice that consists of the
        repetition of a spiritual word, one-pointed attention, and slowing down. MRP has been shown
        to reduce stress in several high-risk populations, and two large randomized, controlled
        studies show that MRP reduces PTSD symptoms among Veterans. A brief, web-based, self-directed
        version of MRP has been developed to increase the accessibility of evidence-based PTSD
        treatment. This version of MRP was tested in a pilot study with undergraduate students,
        demonstrating its ease of use and success in getting students to engage with the practice.
        The proposed mixed method study will use the Reach, Effectiveness, Adoption, Implementation,
        Maintenance (RE-AIM) framework to evaluate the mobile MRP in Veterans with PTSD in two
        conditions: self-directed and with text/phone support. Data from this pilot study will inform
        the refinement of the MRP delivery strategy and the development of a full-scale trial to test
        its effectiveness and implementation outcomes, as well as barriers and facilitators, and
        other contextual factors.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Internet-based instruction in MRP in a self-directed or supported manner
  primary purpose: Other
  masking: None (Open Label)
  measure: Eligibility rate
  time frame: Day 0
  description: Rate of eligibility among those screened for participation
  measure: Initiation rate
  time frame: Day 1
  description: Rate of intervention initiation among eligible Veterans
  measure: Completion rate
  time frame: Day 28
  description: Rate of intervention completion among eligible Veterans
  measure: Credibility
  time frame: Day 1
  description: Average Veteran perception of the logic, utility and expected benefit of treatment rated on a scale of 0 (not at all) to 8 (very)
  measure: Client Satisfaction Questionnaire (CSQ-8)
  time frame: Day 28
  description: Degree of satisfaction with care received as measured by a CSQ-8 total score. Scores range from 8-32 with higher scores indicating greater satisfaction.
  measure: Acceptability of Intervention Measure (AIM)
  time frame: Day 28
  description: Perceived acceptability of the intervention as measured by an AIM average score. Scores range from 1-5 with higher scores indicating greater acceptability.
  measure: Intervention Appropriateness Measure (IAM)
  time frame: Day 28
  description: Perceived appropriateness of the intervention as measured by an IAM average score. Scores range from 1-5 with higher scores indicating greater appropriateness.
  measure: Feasibility of Intervention Measure (FIM)
  time frame: Day 28
  description: Perceived feasibility of the intervention as measured by an FIM average score. Scores range from 1-5 with higher scores indicating greater feasibility.
  measure: Mantram practice
  time frame: Weeks 2-4
  description: Frequency of mantram practice in the past week as 0-7 days
  measure: PTSD Checklist for DSM-5 (PCL-5)
  time frame: Day 0-28
  description: Change in PTSD symptoms from baseline to post-treatment as measured by change in the PCL-5 total score. Scores range from 0-80 with higher scores indicating greater PTSD symptoms.
  measure: Patient Health Questionnaire depression items (PHQ-9)
  time frame: Day 0-28
  description: Change in depression from baseline to post-treatment as measured by change in the PHQ-9 total score. Scores range from 0-27 with higher scores indicating greater depression.
  measure: Insomnia Severity Index
  time frame: Day 0-28
  description: Change in insomnia from baseline to post-treatment as measured by change in the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia.
  arm group label: Self-directed MRP
  arm group type: Experimental
  description: Self-directed instruction in MRP via Internet
  arm group label: Supported MRP
  arm group type: Active Comparator
  description: Supported instruction in MRP via Internet
  intervention type: Behavioral
  intervention name: Mobile Mantram Repetition Program
  description: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down
  arm group label: Self-directed MRP
  arm group label: Supported MRP
  other name: mMRP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ariel J. Lang, PhD
  role: Principal Investigator
  affiliation: VA San Diego Healthcare System, San Diego, CA
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No
  provided document: 
  submitted: August 24, 2023