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/NCT05989841</url>
    </required_header>
    <id_info>
      <org_study_id>UNLV 2023-32</org_study_id>
      <nct_id>NCT05989841</nct_id>
    </id_info>
    <brief_title>Mitigating PTSD-CUD After Sexual Assault</brief_title>
    <acronym>RISE-C</acronym>
    <official_title>Mitigating PTSD-CUD Among Women Presenting to Emergency Care After Sexual Assault: Testing a Digital Therapeutic Targeting Anxiety Sensitivity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Nevada, Las Vegas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Nevada, Las Vegas</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>
        683,000 women are sexually assaulted annually in the United States, half of whom develop&#xD;
        chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for&#xD;
        cannabis use disorder (CUD). The current proposal will test the acceptability, initial&#xD;
        efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD,&#xD;
        which could address the critical need for PTSD-CUD prevention for the 100,000 women who&#xD;
        annually present for emergency care after sexual assault. In this research context, the&#xD;
        applicant will receive key training in multisite, emergency-care based randomized clinical&#xD;
        trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment&#xD;
        data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development,&#xD;
        launching her independent research career focused on reducing the public health burden of&#xD;
        PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">May 2028</completion_date>
    <primary_completion_date type="Anticipated">May 2028</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety Sensitivity Index-3 (ASI-3)</measure>
      <time_frame>6 weeks</time_frame>
      <description>18-item self-report measure of anxiety sensitivity assessing all three subdomains of anxiety sensitivity (physical, cognitive, social). Participants respond to 18 items (e.g., It scares me when my heart beats rapidly) on a 4-point Likert scale. Scores range from 0-72, with higher scores indicating higher levels of anxiety sensitivity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Marijuana Problems Scale (MPS)</measure>
      <time_frame>6 months</time_frame>
      <description>19-item self-report measure of problems related to cannabis use (e.g., problems with work, school, social functioning). Participants rate 19 items on a 3- point Likert scale. Scores range from 0 to 38, with higher scores indicating more problems related to cannabis use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Marijuana Motives Measure - Coping</measure>
      <time_frame>6 months</time_frame>
      <description>The MMM is a 25-item self-report measure of cannabis motives, including coping-oriented motives for cannabis use. Participants respond to a list of motives (e.g., to forget my worries, to get high) on a 5-point Likert scale. Scores range from 25 to 125 for the entire measure, with higher scores indicating higher levels of various types of marijuana motives. The primary motive that will be used as an outcome is coping motives (scores range from 4 to 20 on this subscale).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measurement Information System - Anxiety Measurement Information System (PROMIS) Anxiety and Depression</measure>
      <time_frame>6 months</time_frame>
      <description>7-items assessing self-reported symptoms of anxiety (e.g., anxious, worried, nervous) rated on a 5-point scale. Scores range from 7 to 35, with higher scores indicating higher levels of anxiety. T-scores are used for final scoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measurement Information System - Depression Measurement Information System (PROMIS) Anxiety and Depression</measure>
      <time_frame>6 months</time_frame>
      <description>8 items assessing self-reported symptoms of depression (e.g., worthlessness, helplessness, sadness) rated on a 5-point scale. Scores range from 8 to 40, with higher scores indicating higher levels of depression. T-scores are used for final scoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cannabis Use Frequency</measure>
      <time_frame>6 weeks</time_frame>
      <description>Ecological momentary assessment will include self-report measures of whether or not cannabis was used that day (yes/no). The item will be scored as 0 (no) vs. 1 (yes), with higher scores indicating higher levels of cannabis use frequency.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cannabis Use Quantity</measure>
      <time_frame>6 weeks</time_frame>
      <description>Ecological momentary assessment will assess quantity of cannabis used on an 8-point scale, assessed 1x/day over 6 weeks. Scores will range from 1-8, with higher scores indicating a higher quantity of cannabis consumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Marijuana Cravings - Emotionality Questionnaire</measure>
      <time_frame>6 weeks</time_frame>
      <description>Ecological momentary assessment will include a state version of the emotionality subscale of the Marijuana Cravings Questionnaire. This consists of 4 items rated on a 7-point Likert scale, assessed 4x/day over 6 weeks. Scores range from 4 to 28, with higher scores indicating higher levels of cravings.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PTSD Checklist for Diagnostic and Statistical Manual -5 (DSM-5) (PCL-5)</measure>
      <time_frame>6 months</time_frame>
      <description>20-item self-report measure of DSM-5 PTSD symptoms, including 4 symptom clusters of PTSD (re-experiencing, avoidance, negative alterations in cognition and mood, alterations in arousal and reactivity). Participants respond to items corresponding to each DSM-5 symptom of PTSD on a 5-point Likert scale (0 to 4). Scores range from 0 to 80, with higher scores indicating higher levels of PTSD symptoms.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Posttraumatic Stress Disorder</condition>
    <condition>Cannabis Use Disorder</condition>
    <arm_group>
      <arm_group_label>RISE Guide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Brief cognitive behavioral intervention completed in the 3 weeks post-assault delivered via Internet on participants' smartphones targeting anxiety sensitivity, or fear of anxious arousal. Patients learn psychoeducation regarding the nature of stress, cognitive retraining to reduce negative interpretations of stress, and how to complete interoceptive exposures to reduce anxiety sensitivity. These skills are supported by 6 concurrent then subsequent weeks of ecological momentary intervention to deliver personalized intervention reminders based on symptoms.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Relaxation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will download the &quot;Breathe2Relax&quot; app, which delivers information about how to use diaphragm breathing (taking slow, deep breaths through the diaphragm) to manage stress. Participants will receive reminders to engage with the intervention. Participants will also receive ecological momentary intervention reminders to engage with the relaxation intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>RISE Guide</intervention_name>
      <description>Brief cognitive behavioral intervention completed in the 3 weeks post-assault delivered via Internet on participants' smartphones targeting anxiety sensitivity, or fear of anxious arousal. Patients learn psychoeducation regarding the nature of stress, cognitive retraining to reduce negative interpretations of stress, and how to complete interoceptive exposures to reduce anxiety sensitivity. These skills are supported by 6 concurrent then subsequent weeks of ecological momentary intervention to deliver personalized intervention reminders based on symptoms.</description>
      <arm_group_label>RISE Guide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Relaxation Control</intervention_name>
      <description>Patients will download the &quot;Breathe2Relax&quot; app, which delivers information about how to use diaphragm breathing (taking slow, deep breaths through the diaphragm) to manage stress. Participants will receive reminders to engage with the intervention. Participants will also receive ecological momentary intervention reminders to engage with the relaxation intervention.</description>
      <arm_group_label>Relaxation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Women sexual assault survivors presenting for emergency care &lt;72 hours post-assault at&#xD;
               1 of our 4 emergency care sites&#xD;
  &#xD;
            2. English speakers&#xD;
  &#xD;
            3. 18+ years of age&#xD;
  &#xD;
            4. Able to provide informed consent&#xD;
  &#xD;
            5. Have a smartphone with continuous service &gt;1 year&#xD;
  &#xD;
            6. Report &gt;1x/weekly cannabis use on a substance use screener&#xD;
  &#xD;
            7. Report elevated AS (&gt;17 on the Anxiety Sensitivity Index-3)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Inability to provide informed consent (e.g., serious injury preventing the ability to&#xD;
               hear, speak, or see to consent and participate, or other causes (e.g., diagnosed&#xD;
               cognitive deficits, diagnosed dementia, asleep at time of screening)).&#xD;
  &#xD;
            2. Prisoner&#xD;
  &#xD;
            3. Currently pregnant&#xD;
  &#xD;
            4. Lives with assailant and plans to continue to do so&#xD;
  &#xD;
            5. Admitted patient&#xD;
  &#xD;
            6. No mailing address&#xD;
  &#xD;
            7. Previously enrolled&#xD;
  &#xD;
            8. No sexual assault nurse examiner (SANE) examination&#xD;
  &#xD;
            9. Reporting current plan and intent for suicide or homicide&#xD;
  &#xD;
           10. Does not understand written and spoken English&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Assigned female at birth and currently identifying as female</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nicole A Short, PhD</last_name>
      <phone>7028950606</phone>
      <email>nicole.short@unlv.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Medical Center</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89102</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jordana Haber, MD</last_name>
        <phone>702-383-2000</phone>
        <email>jordana.haber@unlv.edu</email>
      </contact>
      <investigator>
        <last_name>Jordana Haber, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>UNC Chapel Hill</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Karen Serrano, MD</last_name>
        <phone>919-966-6442</phone>
        <email>kserrano@email.unc.edu</email>
      </contact>
      <investigator>
        <last_name>Karen Serrano, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tulsa Forensic Nursing</name>
        <address>
          <city>Tulsa</city>
          <state>Oklahoma</state>
          <zip>74103</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kasey Magness, BSN</last_name>
        <phone>918-743-5763</phone>
        <email>kmagness@cityoftulsa.org</email>
      </contact>
      <investigator>
        <last_name>Kasey Magness, BSN</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>SAFE Austin</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>74103</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jenny Black, BSN</last_name>
        <phone>512-267-7233</phone>
        <email>jblack@safeaustin.org</email>
      </contact>
      <investigator>
        <last_name>Jenny Black, BSN</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <!-- 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/NCT05989841
  org study id: UNLV 2023-32
  nct id: NCT05989841
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  683,000 women are sexually assaulted annually in the United States, half of whom develop
        chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for
        cannabis use disorder (CUD). The current proposal will test the acceptability, initial
        efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD,
        which could address the critical need for PTSD-CUD prevention for the 100,000 women who
        annually present for emergency care after sexual assault. In this research context, the
        applicant will receive key training in multisite, emergency-care based randomized clinical
        trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment
        data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development,
        launching her independent research career focused on reducing the public health burden of
        PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Anxiety Sensitivity Index-3 (ASI-3)
  time frame: 6 weeks
  description: 18-item self-report measure of anxiety sensitivity assessing all three subdomains of anxiety sensitivity (physical, cognitive, social). Participants respond to 18 items (e.g., It scares me when my heart beats rapidly) on a 4-point Likert scale. Scores range from 0-72, with higher scores indicating higher levels of anxiety sensitivity.
  measure: Marijuana Problems Scale (MPS)
  time frame: 6 months
  description: 19-item self-report measure of problems related to cannabis use (e.g., problems with work, school, social functioning). Participants rate 19 items on a 3- point Likert scale. Scores range from 0 to 38, with higher scores indicating more problems related to cannabis use.
  measure: Marijuana Motives Measure - Coping
  time frame: 6 months
  description: The MMM is a 25-item self-report measure of cannabis motives, including coping-oriented motives for cannabis use. Participants respond to a list of motives (e.g., to forget my worries, to get high) on a 5-point Likert scale. Scores range from 25 to 125 for the entire measure, with higher scores indicating higher levels of various types of marijuana motives. The primary motive that will be used as an outcome is coping motives (scores range from 4 to 20 on this subscale).
  measure: Patient Reported Outcome Measurement Information System - Anxiety Measurement Information System (PROMIS) Anxiety and Depression
  time frame: 6 months
  description: 7-items assessing self-reported symptoms of anxiety (e.g., anxious, worried, nervous) rated on a 5-point scale. Scores range from 7 to 35, with higher scores indicating higher levels of anxiety. T-scores are used for final scoring.
  measure: Patient Reported Outcome Measurement Information System - Depression Measurement Information System (PROMIS) Anxiety and Depression
  time frame: 6 months
  description: 8 items assessing self-reported symptoms of depression (e.g., worthlessness, helplessness, sadness) rated on a 5-point scale. Scores range from 8 to 40, with higher scores indicating higher levels of depression. T-scores are used for final scoring.
  measure: Cannabis Use Frequency
  time frame: 6 weeks
  description: Ecological momentary assessment will include self-report measures of whether or not cannabis was used that day (yes/no). The item will be scored as 0 (no) vs. 1 (yes), with higher scores indicating higher levels of cannabis use frequency.
  measure: Cannabis Use Quantity
  time frame: 6 weeks
  description: Ecological momentary assessment will assess quantity of cannabis used on an 8-point scale, assessed 1x/day over 6 weeks. Scores will range from 1-8, with higher scores indicating a higher quantity of cannabis consumed.
  measure: Marijuana Cravings - Emotionality Questionnaire
  time frame: 6 weeks
  description: Ecological momentary assessment will include a state version of the emotionality subscale of the Marijuana Cravings Questionnaire. This consists of 4 items rated on a 7-point Likert scale, assessed 4x/day over 6 weeks. Scores range from 4 to 28, with higher scores indicating higher levels of cravings.
  measure: PTSD Checklist for Diagnostic and Statistical Manual -5 (DSM-5) (PCL-5)
  time frame: 6 months
  description: 20-item self-report measure of DSM-5 PTSD symptoms, including 4 symptom clusters of PTSD (re-experiencing, avoidance, negative alterations in cognition and mood, alterations in arousal and reactivity). Participants respond to items corresponding to each DSM-5 symptom of PTSD on a 5-point Likert scale (0 to 4). Scores range from 0 to 80, with higher scores indicating higher levels of PTSD symptoms.
  arm group label: RISE Guide
  arm group type: Experimental
  description: Brief cognitive behavioral intervention completed in the 3 weeks post-assault delivered via Internet on participants' smartphones targeting anxiety sensitivity, or fear of anxious arousal. Patients learn psychoeducation regarding the nature of stress, cognitive retraining to reduce negative interpretations of stress, and how to complete interoceptive exposures to reduce anxiety sensitivity. These skills are supported by 6 concurrent then subsequent weeks of ecological momentary intervention to deliver personalized intervention reminders based on symptoms.
  arm group label: Relaxation
  arm group type: Active Comparator
  description: Patients will download the "Breathe2Relax" app, which delivers information about how to use diaphragm breathing (taking slow, deep breaths through the diaphragm) to manage stress. Participants will receive reminders to engage with the intervention. Participants will also receive ecological momentary intervention reminders to engage with the relaxation intervention.
  intervention type: Behavioral
  intervention name: RISE Guide
  description: Brief cognitive behavioral intervention completed in the 3 weeks post-assault delivered via Internet on participants' smartphones targeting anxiety sensitivity, or fear of anxious arousal. Patients learn psychoeducation regarding the nature of stress, cognitive retraining to reduce negative interpretations of stress, and how to complete interoceptive exposures to reduce anxiety sensitivity. These skills are supported by 6 concurrent then subsequent weeks of ecological momentary intervention to deliver personalized intervention reminders based on symptoms.
  arm group label: RISE Guide
  intervention type: Behavioral
  intervention name: Relaxation Control
  description: Patients will download the "Breathe2Relax" app, which delivers information about how to use diaphragm breathing (taking slow, deep breaths through the diaphragm) to manage stress. Participants will receive reminders to engage with the intervention. Participants will also receive ecological momentary intervention reminders to engage with the relaxation intervention.
  arm group label: Relaxation
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Assigned female at birth and currently identifying as female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nicole A Short, PhD
  phone: 7028950606
  email: nicole.short@unlv.edu
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stress Disorders, Post-Traumatic