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/NCT05980104</url>
    </required_header>
    <id_info>
      <org_study_id>68906</org_study_id>
      <nct_id>NCT05980104</nct_id>
    </id_info>
    <brief_title>Single-Session &quot;Empowered Relief&quot; Class for Marfan Syndrome and Related Conditions</brief_title>
    <official_title>Virtual Single-Session &quot;Empowered Relief&quot; Class for Individuals With Marfan Syndrome and Related Conditions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to conduct a feasibility clinical trial by implementing a&#xD;
        1-session pain relief skills intervention (Empowered Relief; two hours total treatment time)&#xD;
        for individuals with Marfan syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome,&#xD;
        and related conditions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will implement a single arm online feasibility and preliminary efficacy&#xD;
        trial of a pain relief skills intervention &quot;Empowered Relief&quot; to reduce pain metrics for&#xD;
        individuals with Marfan syndrome and related conditions. Completion of the brief&#xD;
        post-treatment survey is a binary measure of treatment engagement; treatment feasibility and&#xD;
        appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to&#xD;
        use skills learned). Electronic surveys will measure pain intensity and symptom status at:&#xD;
        baseline, immediately post-treatment; at post-treatment week 2 and months 1, 2, and 3.&#xD;
  &#xD;
        Online delivery of evidence-based behavioral treatment for pain will greatly expand access to&#xD;
        patients across the U.S. living with Marfan syndrome and related conditions and associated&#xD;
        chronic pain. Results from this study will fill several critical gaps in evidence for pain&#xD;
        care in this population.&#xD;
  &#xD;
        This study will provide a low-cost, low-risk, widely available and feasible protocol that may&#xD;
        help address the needs of patients living with Marfan and related syndromes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants registered for class</measure>
      <time_frame>baseline</time_frame>
      <description>Full registration for the online session (N=100)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Class attendance</measure>
      <time_frame>at treatment</time_frame>
      <description>60% attendance rate (N=60)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment appraisal</measure>
      <time_frame>immediately post-treatment</time_frame>
      <description>8 items assess satisfaction and perceived utility of assigned treatment using 7 and 11-point scales where higher ratings represent greater satisfaction with the treatment. We aim to achieve 80% ratings for treatment satisfaction (combined items) rated immediately post-treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain Intensity</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post reductions at 3 months with the Patient Reported Outcomes Measurement Systems (PROMIS) Pain Intensity 1-item scale assessing average pain intensity for the past 7 days (0= &quot;No pain&quot; to 10= &quot;Worst pain imaginable&quot;) where a higher score represents a greater degree of pain intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Catastrophizing</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 months with the Pain Catastrophizing 13-item scale quantifying an individual's pain experience (5 point scale where 0 = &quot;Not at all&quot; and 4 = &quot;All the time&quot;). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pain Intensity</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post reductions at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Intensity 1-item scale assessing average pain intensity for the past 7 days (0= &quot;No pain&quot; to 10= &quot;Worst pain imaginable&quot;) where a higher score represents a greater degree of pain intensity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Catastrophizing</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Pain Catastrophizing 13-item scale quantifying an individual's pain experience. Reponses range from 0 = &quot;Not at all&quot; and 4 = &quot;All the time&quot;. Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Interference</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = &quot;Not at all&quot; to 5 = &quot;Very much&quot; where higher scores represent a greater degree of pain interference.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Interference</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = &quot;Not at all&quot; to 5 = &quot;Very much&quot; where higher scores represent a greater degree of pain interference.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep Disturbance</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 6-item scale assessing sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep Disturbance</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 6-item scale assessing sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Bothersomeness</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 months with the Pain Bothersomeness 1-item scale assessing pain bothersomeness over the past 7 days. Responses range from 0 = &quot;Not at all bothersome&quot; to 10 = &quot;Extremely bothersome&quot; where higher scores represent a greater degree of pain bothersomeness.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Bothersomeness</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Pain Bothersomeness 1-item scale assessing pain bothersomeness over the past 7 days. Responses range from 0 = &quot;Not at all bothersome&quot; to 10 = &quot;Extremely bothersome&quot; where higher scores represent a greater degree of pain bothersomeness.</description>
    </other_outcome>
    <other_outcome>
      <measure>Fatigue</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Fatigue 8-item scale assessing fatigue over the past 7 days. Responses range from 1 = &quot;Not at all&quot; and &quot;Never&quot; to 5 = &quot;Very much&quot; and &quot;Always&quot; where higher scores represent a greater degree of fatigue.</description>
    </other_outcome>
    <other_outcome>
      <measure>Fatigue</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Fatigue 8-item scale assessing fatigue over the past 7 days. Responses range from 1 = &quot;Not at all&quot; and &quot;Never&quot; to 5 = &quot;Very much&quot; and &quot;Always&quot; where higher scores represent a greater degree of fatigue.</description>
    </other_outcome>
    <other_outcome>
      <measure>Satisfaction with Participation in Social Roles</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Satisfaction with Participation in Social Roles 7-item scale assessing satisfaction with performing one's usual social roles and activities. Responses range from 1 = &quot;Not at all&quot; to 5 &quot;Very much&quot; where higher scores represent greater satisfaction.</description>
    </other_outcome>
    <other_outcome>
      <measure>Satisfaction with Participation in Social Roles</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Satisfaction with Participation in Social Roles 7-item scale assessing satisfaction with performing one's usual social roles and activities. Responses range from 1 = &quot;Not at all&quot; to 5 &quot;Very much&quot; where higher scores represent greater satisfaction.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Self-Efficacy Questionnaire</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 months with the Pain Self-Efficacy Questionnaire 2-item scale assessing confidence in functioning in the presence of pain. Responses range from 0 = &quot;Not at all confident&quot; to 6 = &quot;Completely confident&quot; where higher scores represent greater confidence in functioning.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Self-Efficacy Questionnaire</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Pain Self-Efficacy 2-item scale assessing confidence in functioning in the presence of pain. Responses range from 0 = &quot;Not at all confident&quot; to 6 = &quot;Completely confident&quot; where higher scores represent greater confidence in functioning.</description>
    </other_outcome>
    <other_outcome>
      <measure>Depression</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Depression 6-item scale assessing negative mood in the past 7 days. Responses range from 1 = &quot;Never&quot; to 5 = &quot;Always&quot; where higher scores represent greater degree of depression.</description>
    </other_outcome>
    <other_outcome>
      <measure>Depression</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Depression 6-item scale assessing negative mood in the past 7 days. Responses range from 1 = &quot;Never&quot; to 5 = &quot;Always&quot; where higher scores represent greater degree of depression.</description>
    </other_outcome>
    <other_outcome>
      <measure>Anxiety</measure>
      <time_frame>post-treatment month 3</time_frame>
      <description>Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Anxiety 6-item scale assessing fearfulness, worry and nervousness in the past 7 days. Responses range from 1 = &quot;Never&quot; to 5 = &quot;Always&quot; where higher scores represent greater degree of anxiety.</description>
    </other_outcome>
    <other_outcome>
      <measure>Anxiety</measure>
      <time_frame>post-treatment month 1</time_frame>
      <description>Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Anxiety 6-item scale assessing fearfulness, worry and nervousness in the past 7 days. Responses range from 1 = &quot;Never&quot; to 5 = &quot;Always&quot; where higher scores represent greater degree of anxiety.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Chronic Pain</condition>
    <condition>Marfan Syndrome</condition>
    <condition>Vascular Ehlers-Danlos Syndrome</condition>
    <condition>Loeys-Dietz Syndrome</condition>
    <arm_group>
      <arm_group_label>Empowered Relief</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to a group of patients by a certified instructor using a standardized treatment manual and electronic slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Empowered Relief</intervention_name>
      <description>A certified instructor delivers 1 online session of a pain relief skills intervention (Empowered Relief) to one group of patients</description>
      <arm_group_label>Empowered Relief</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and females 18 years of age or older&#xD;
  &#xD;
            -  Marfan Syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome or related&#xD;
               connective tissue disease and chronic pain&#xD;
  &#xD;
            -  English fluency&#xD;
  &#xD;
            -  Ability to adhere to and complete study protocols&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cognitive impairment, non-English speaking, or psychological factors that would&#xD;
               preclude comprehension of material and/or full participation in the study.&#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>Beth Darnall, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Beth Darnall, PhD</last_name>
      <phone>650-723-2040</phone>
      <email>bdarnall@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Corinne Jung, PhD</last_name>
      <phone>650-724-0522</phone>
      <email>cejung@stanford.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Beth Darnall</investigator_full_name>
      <investigator_title>Director of Stanford Pain Relief Innovations Lab</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Marfan Syndrome</mesh_term>
      <mesh_term>Arachnodactyly</mesh_term>
      <mesh_term>Loeys-Dietz Syndrome</mesh_term>
      <mesh_term>Ehlers-Danlos Syndrome</mesh_term>
      <mesh_term>Ehlers-Danlos Syndrome, Type IV</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Chronic Pain</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/NCT05980104
  org study id: 68906
  nct id: NCT05980104
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to conduct a feasibility clinical trial by implementing a
        1-session pain relief skills intervention (Empowered Relief; two hours total treatment time)
        for individuals with Marfan syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome,
        and related conditions.
  The investigators will implement a single arm online feasibility and preliminary efficacy
        trial of a pain relief skills intervention "Empowered Relief" to reduce pain metrics for
        individuals with Marfan syndrome and related conditions. Completion of the brief
        post-treatment survey is a binary measure of treatment engagement; treatment feasibility and
        appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to
        use skills learned). Electronic surveys will measure pain intensity and symptom status at:
        baseline, immediately post-treatment; at post-treatment week 2 and months 1, 2, and 3.
  
        Online delivery of evidence-based behavioral treatment for pain will greatly expand access to
        patients across the U.S. living with Marfan syndrome and related conditions and associated
        chronic pain. Results from this study will fill several critical gaps in evidence for pain
        care in this population.
  
        This study will provide a low-cost, low-risk, widely available and feasible protocol that may
        help address the needs of patients living with Marfan and related syndromes.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants registered for class
  time frame: baseline
  description: Full registration for the online session (N=100)
  measure: Class attendance
  time frame: at treatment
  description: 60% attendance rate (N=60)
  measure: Treatment appraisal
  time frame: immediately post-treatment
  description: 8 items assess satisfaction and perceived utility of assigned treatment using 7 and 11-point scales where higher ratings represent greater satisfaction with the treatment. We aim to achieve 80% ratings for treatment satisfaction (combined items) rated immediately post-treatment.
  measure: Pain Intensity
  time frame: post-treatment month 3
  description: Group pre-post reductions at 3 months with the Patient Reported Outcomes Measurement Systems (PROMIS) Pain Intensity 1-item scale assessing average pain intensity for the past 7 days (0= "No pain" to 10= "Worst pain imaginable") where a higher score represents a greater degree of pain intensity.
  measure: Pain Catastrophizing
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 months with the Pain Catastrophizing 13-item scale quantifying an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
  measure: Pain Intensity
  time frame: post-treatment month 1
  description: Group pre-post reductions at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Intensity 1-item scale assessing average pain intensity for the past 7 days (0= "No pain" to 10= "Worst pain imaginable") where a higher score represents a greater degree of pain intensity.
  measure: Pain Catastrophizing
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Pain Catastrophizing 13-item scale quantifying an individual's pain experience. Reponses range from 0 = "Not at all" and 4 = "All the time". Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
  measure: Pain Interference
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" where higher scores represent a greater degree of pain interference.
  measure: Pain Interference
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" where higher scores represent a greater degree of pain interference.
  measure: Sleep Disturbance
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 6-item scale assessing sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality.
  measure: Sleep Disturbance
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 6-item scale assessing sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality.
  measure: Pain Bothersomeness
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 months with the Pain Bothersomeness 1-item scale assessing pain bothersomeness over the past 7 days. Responses range from 0 = "Not at all bothersome" to 10 = "Extremely bothersome" where higher scores represent a greater degree of pain bothersomeness.
  measure: Pain Bothersomeness
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Pain Bothersomeness 1-item scale assessing pain bothersomeness over the past 7 days. Responses range from 0 = "Not at all bothersome" to 10 = "Extremely bothersome" where higher scores represent a greater degree of pain bothersomeness.
  measure: Fatigue
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Fatigue 8-item scale assessing fatigue over the past 7 days. Responses range from 1 = "Not at all" and "Never" to 5 = "Very much" and "Always" where higher scores represent a greater degree of fatigue.
  measure: Fatigue
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Fatigue 8-item scale assessing fatigue over the past 7 days. Responses range from 1 = "Not at all" and "Never" to 5 = "Very much" and "Always" where higher scores represent a greater degree of fatigue.
  measure: Satisfaction with Participation in Social Roles
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Satisfaction with Participation in Social Roles 7-item scale assessing satisfaction with performing one's usual social roles and activities. Responses range from 1 = "Not at all" to 5 "Very much" where higher scores represent greater satisfaction.
  measure: Satisfaction with Participation in Social Roles
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Satisfaction with Participation in Social Roles 7-item scale assessing satisfaction with performing one's usual social roles and activities. Responses range from 1 = "Not at all" to 5 "Very much" where higher scores represent greater satisfaction.
  measure: Pain Self-Efficacy Questionnaire
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 months with the Pain Self-Efficacy Questionnaire 2-item scale assessing confidence in functioning in the presence of pain. Responses range from 0 = "Not at all confident" to 6 = "Completely confident" where higher scores represent greater confidence in functioning.
  measure: Pain Self-Efficacy Questionnaire
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Pain Self-Efficacy 2-item scale assessing confidence in functioning in the presence of pain. Responses range from 0 = "Not at all confident" to 6 = "Completely confident" where higher scores represent greater confidence in functioning.
  measure: Depression
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Depression 6-item scale assessing negative mood in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of depression.
  measure: Depression
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Depression 6-item scale assessing negative mood in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of depression.
  measure: Anxiety
  time frame: post-treatment month 3
  description: Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Anxiety 6-item scale assessing fearfulness, worry and nervousness in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of anxiety.
  measure: Anxiety
  time frame: post-treatment month 1
  description: Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Anxiety 6-item scale assessing fearfulness, worry and nervousness in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of anxiety.
  arm group label: Empowered Relief
  arm group type: Experimental
  description: Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to a group of patients by a certified instructor using a standardized treatment manual and electronic slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.
  intervention type: Behavioral
  intervention name: Empowered Relief
  description: A certified instructor delivers 1 online session of a pain relief skills intervention (Empowered Relief) to one group of patients
  arm group label: Empowered Relief
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Beth Darnall, PhD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Beth Darnall, PhD
  phone: 650-723-2040
  email: bdarnall@stanford.edu
  last name: Corinne Jung, PhD
  phone: 650-724-0522
  email: cejung@stanford.edu
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Beth Darnall
  investigator title: Director of Stanford Pain Relief Innovations Lab
  mesh term: Marfan Syndrome
  mesh term: Arachnodactyly
  mesh term: Loeys-Dietz Syndrome
  mesh term: Ehlers-Danlos Syndrome
  mesh term: Ehlers-Danlos Syndrome, Type IV
  mesh term: Syndrome
  mesh term: Chronic Pain