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/NCT05998369</url>
    </required_header>
    <id_info>
      <org_study_id>68451</org_study_id>
      <nct_id>NCT05998369</nct_id>
    </id_info>
    <brief_title>Empowered Relief for Youth</brief_title>
    <acronym>ER-Y</acronym>
    <official_title>Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain</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 pilot study is to examine the feasibility and preliminary efficacy of&#xD;
        Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single-session pain management&#xD;
        class for youth focused on pain science education and teaching self-regulatory skills for&#xD;
        pain management based on the evidence-based adult ER class. Feasibility and acceptability of&#xD;
        ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering&#xD;
        surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The current proposed, single-arm, uncontrolled pilot study will determine a) feasibility of&#xD;
        ER-Y in youth with chronic pain, b) patients' perceptions and satisfaction of the ER-Y class&#xD;
        and c) preliminary efficacy to inform the design of a subsequent randomized controlled trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>Treatment Expectancy Credibility (TEC-C)</measure>
      <time_frame>Immediately post class</time_frame>
      <description>The TEC-C assess treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = &quot;not at all&quot; to 10 = &quot;very much&quot;) with a higher score indicating high expectations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Program Feedback Scale</measure>
      <time_frame>Immediately post class</time_frame>
      <description>The Program Feedback Scale assesses participants agreement to seven statements indicating their perceived acceptability and feasibility based on a scale (score 0 = &quot;really disagree&quot; to 4 = &quot;really agree&quot;) with a higher score indicating positive feedback and two open ended questions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PROMIS Pain Interference</measure>
      <time_frame>Pre class, 4 weeks, 8 weeks, and 12 weeks post class</time_frame>
      <description>The PROMIS Pain Interference form assesses to what level pain hinders their engagement in several activities using a ranked scale (score 0 = &quot;never&quot; to 4 = &quot;almost always&quot;) with a higher score indicating great pain interference.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Change (PGIC)</measure>
      <time_frame>4 weeks, 8 weeks, and 12 weeks post class</time_frame>
      <description>The Pain Global Impression of Change survey asks participants to rank how their overall pain has changed since the start of study using a ranked scale (score 0 = &quot;very much improved&quot; to 6 = &quot;very much worse&quot;) with higher scores indicating greater severity to their pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Catastrophizing Scale (PCS)</measure>
      <time_frame>Pre class, 4 weeks, 8 weeks, and 12 weeks post class</time_frame>
      <description>The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (score 0= &quot;not at all true&quot; to 4 &quot;very true&quot;). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Child Pain Self-Efficacy Scale (PSES-C)</measure>
      <time_frame>Pre class, 4 weeks, 8 weeks, and 12 weeks post class</time_frame>
      <description>The Child Pain Self- Efficacy Scale assesses the participants self-efficacy with regard to normal functioning when in pain based on a ranked scale (score 1 = &quot;very sure&quot; to 5 = &quot;very unsure&quot;) with higher scores indicating enhanced uncertainty.</description>
    </other_outcome>
    <other_outcome>
      <measure>PROMIS Anxiety</measure>
      <time_frame>Pre class, 4 weeks, 8 weeks, and 12 weeks post class</time_frame>
      <description>The PROMIS anxiety study assesses fear, fear, misery, hyperarousal, and somatic symptoms related to arousal within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = &quot;never&quot; to 5 = &quot;almost always&quot;) with higher scores indicating greater experience to anxiety.</description>
    </other_outcome>
    <other_outcome>
      <measure>PROMIS Depression</measure>
      <time_frame>Pre class, 4 weeks, 8 weeks, and 12 weeks post class</time_frame>
      <description>The PROMIS depression study assesses symptoms related to depression within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = &quot;never&quot; to 5 = &quot;almost always&quot;) with higher scores indicating greater depressive symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Hope Scale</measure>
      <time_frame>Pre class, 4 weeks, 8 weeks, and 12 weeks post class</time_frame>
      <description>The Hope Scale assess the participant's hope level based on a ranked scale (score 1 = &quot;definitely false&quot; to 8 = &quot;definitely true&quot;) with a higher score indicating highly hopeful.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Chronic Pain</condition>
    <condition>Musculoskeletal Pain</condition>
    <condition>Fibromyalgia</condition>
    <condition>Neuropathic Pain</condition>
    <condition>Complex Regional Pain Syndromes</condition>
    <condition>Abdominal Pain</condition>
    <arm_group>
      <arm_group_label>Empowered Relief for Youth</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Empowered Relief for Youth is a single-session pain management class focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Empowered Relief for Youth</intervention_name>
      <description>The Empowered Relief for Youth is a 90-minute class that provides pain science education, as well as cognitive, emotional, and physiologic self-regulation skills for youth with chronic pain. Youth will also develop a personalized plan to use the acquired skills daily. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.</description>
      <arm_group_label>Empowered Relief for Youth</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age at least 10 years old to 18 years&#xD;
  &#xD;
            -  Diagnosis of Chronic Pain&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental&#xD;
               delay&#xD;
  &#xD;
            -  Severe affective disorder (e.g., severe depression/ anxiety) from medical record&#xD;
               review.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laura Simons, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dylan Mayanja, BA</last_name>
      <phone>650-736-2945</phone>
      <email>dmayanja@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jeremy Giberson, MAS</last_name>
      <email>jgiberso@stanford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Laura Simons, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lauren Harrison, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rashmi Bhandari, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Laura E Simons</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Musculoskeletal Pain</mesh_term>
      <mesh_term>Neuralgia</mesh_term>
      <mesh_term>Complex Regional Pain Syndromes</mesh_term>
      <mesh_term>Reflex Sympathetic Dystrophy</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Abdominal 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/NCT05998369
  org study id: 68451
  nct id: NCT05998369
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this pilot study is to examine the feasibility and preliminary efficacy of
        Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single-session pain management
        class for youth focused on pain science education and teaching self-regulatory skills for
        pain management based on the evidence-based adult ER class. Feasibility and acceptability of
        ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering
        surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class.
  The current proposed, single-arm, uncontrolled pilot study will determine a) feasibility of
        ER-Y in youth with chronic pain, b) patients' perceptions and satisfaction of the ER-Y class
        and c) preliminary efficacy to inform the design of a subsequent randomized controlled trial.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Treatment Expectancy Credibility (TEC-C)
  time frame: Immediately post class
  description: The TEC-C assess treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = "not at all" to 10 = "very much") with a higher score indicating high expectations.
  measure: Program Feedback Scale
  time frame: Immediately post class
  description: The Program Feedback Scale assesses participants agreement to seven statements indicating their perceived acceptability and feasibility based on a scale (score 0 = "really disagree" to 4 = "really agree") with a higher score indicating positive feedback and two open ended questions.
  measure: PROMIS Pain Interference
  time frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
  description: The PROMIS Pain Interference form assesses to what level pain hinders their engagement in several activities using a ranked scale (score 0 = "never" to 4 = "almost always") with a higher score indicating great pain interference.
  measure: Patient Global Impression of Change (PGIC)
  time frame: 4 weeks, 8 weeks, and 12 weeks post class
  description: The Pain Global Impression of Change survey asks participants to rank how their overall pain has changed since the start of study using a ranked scale (score 0 = "very much improved" to 6 = "very much worse") with higher scores indicating greater severity to their pain.
  measure: Pain Catastrophizing Scale (PCS)
  time frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
  description: The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (score 0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.
  measure: Child Pain Self-Efficacy Scale (PSES-C)
  time frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
  description: The Child Pain Self- Efficacy Scale assesses the participants self-efficacy with regard to normal functioning when in pain based on a ranked scale (score 1 = "very sure" to 5 = "very unsure") with higher scores indicating enhanced uncertainty.
  measure: PROMIS Anxiety
  time frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
  description: The PROMIS anxiety study assesses fear, fear, misery, hyperarousal, and somatic symptoms related to arousal within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater experience to anxiety.
  measure: PROMIS Depression
  time frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
  description: The PROMIS depression study assesses symptoms related to depression within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater depressive symptoms.
  measure: Hope Scale
  time frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
  description: The Hope Scale assess the participant's hope level based on a ranked scale (score 1 = "definitely false" to 8 = "definitely true") with a higher score indicating highly hopeful.
  arm group label: Empowered Relief for Youth
  arm group type: Experimental
  description: Empowered Relief for Youth is a single-session pain management class focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class.
  intervention type: Behavioral
  intervention name: Empowered Relief for Youth
  description: The Empowered Relief for Youth is a 90-minute class that provides pain science education, as well as cognitive, emotional, and physiologic self-regulation skills for youth with chronic pain. Youth will also develop a personalized plan to use the acquired skills daily. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
  arm group label: Empowered Relief for Youth
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Laura Simons, PhD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Dylan Mayanja, BA
  phone: 650-736-2945
  email: dmayanja@stanford.edu
  last name: Jeremy Giberson, MAS
  email: jgiberso@stanford.edu
  facility: 
  status: Recruiting
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Laura E Simons
  investigator title: Professor
  mesh term: Fibromyalgia
  mesh term: Musculoskeletal Pain
  mesh term: Neuralgia
  mesh term: Complex Regional Pain Syndromes
  mesh term: Reflex Sympathetic Dystrophy
  mesh term: Chronic Pain
  mesh term: Abdominal Pain