<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/NCT04488757</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00035303</org_study_id>
    <secondary_id>1K23AT010643-01A1</secondary_id>
    <nct_id>NCT04488757</nct_id>
  </id_info>
  <brief_title>Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain</brief_title>
  <official_title>Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's 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>
      Chronic widespread pain (CWP) is a common chronic pain condition in youth and often&#xD;
      associated with significant pain-related and psychosocial impairment. Understanding the&#xD;
      neurobiological mechanisms that may underlie pediatric chronic pain and pain-related&#xD;
      impairment can inform future treatments to ameliorate patients' suffering, making it a&#xD;
      critical area of empirical investigation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric chronic widespread pain (CWP) is a serious public health problem resulting in high&#xD;
      levels of healthcare utilization and disability. Youth with CWP also frequently report&#xD;
      exposure to adverse childhood experiences (ACEs; abuse/neglect, violent/conflictual home&#xD;
      environment, etc.) and a significant subset continue to experience physical and psychosocial&#xD;
      impairment long-term. Certain mind-body interventions such as mindfulness-based stress&#xD;
      reduction (MBSR) or meditation may be particularly appropriate for youth with CWP as they&#xD;
      have been shown to modulate stress-induced maladaptation of the HPA-axis, autonomic nervous&#xD;
      system, cardiovascular system, and brain structure (e.g., hippocampus). However, it is&#xD;
      currently unknown if these targets are affected in youth with CWP. Preliminary research&#xD;
      indicates that allostatic load (AL), or &quot;wear and tear&quot; on the nervous system due to stress,&#xD;
      may contribute to pain chronicity. Similarly, evidence suggests that the hippocampus, a brain&#xD;
      structure that is among the most deleteriously affected by stress, plays a role in pain&#xD;
      perception. However, no study to-date has examined AL and hippocampal functioning in relation&#xD;
      to stress exposure in youth with CWP. Mind-body interventions such as MBSR or meditation are&#xD;
      an important and safe therapy option for both pain and stress reduction in youth with CWP and&#xD;
      may modulate the negative impact of ACEs, so there is a critical need to know if these&#xD;
      mechanisms are engaged in this population. The current study utilizes multifactorial&#xD;
      physiological and neuroimaging measurement techniques to enhance our understanding of the&#xD;
      potential role of these mechanisms in pain-related impairment and responsiveness to mind-body&#xD;
      interventions over time. The aims of this study are to better characterize AL, assessed via a&#xD;
      multifactorial composite, and hippocampal functioning via fMRI in pediatric CWP as specific&#xD;
      targets for mind-body interventions that can lead to treatment optimization and improved&#xD;
      compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 4, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>All participants will undergo fMRI and stress physiology measurement. Intervention outcomes will be compared across two groups: 1. pediatric chronic widespread pain and 2. age and gender matched healthy controls.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hippocampal Functioning</measure>
    <time_frame>baseline</time_frame>
    <description>measured via fMRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Morning Cortisol</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via 2 samples of saliva taken via passive drool over the course of two days. After analysis, morning cortisol will be dichotomously coded with participants receiving a &quot;1&quot; if they score over one standard deviation above the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Dehydroepiandrosterone (DHEA)</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via 2 samples of saliva taken via passive drool over the course of two days. After analysis, DHEA will be dichotomously coded with participants receiving a &quot;1&quot; if they score over one standard deviation above the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Flattened Cortisol</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via 10 samples of saliva taken via passive drool over the course of two days. After analysis, the presence of cortisol will be dichotomously coded with participants receiving a &quot;1&quot; if the change in cortisol levels across the day fell at or below one standard deviation below the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Blood Pressure</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via blood pressure cuff by trained nurse. Results will be coded to capture levels that fall in the &quot;normal&quot;, &quot;prehypertension&quot; and &quot;hypertension&quot; range with individuals scoring in the latter two ranges receiving a coding of &quot;1&quot; to be included in the allostatic load risk composite measure. Scoring of blood pressure ranges will be done using ezbmi- calculates deviation from expected BP/BMI by age/gender.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body-Mass Index (BMI)</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via height and weight (in cm and kg) by a trained nurse. Results will be coded to capture individuals that score in the &quot;underweight&quot;, &quot;normal&quot;, &quot;overweight&quot; and &quot;obese&quot; ranges with individuals falling in all categories but &quot;normal&quot; receiving a coding of &quot;1&quot; to be included in the allostatic load risk ratio. Scoring of BMI ranges will be done using ezbmi- calculates deviation from expected BP/BMI by age/gender.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Waist-Hip Ratio (WHR)</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via tape measure around the smallest part of the waist and the widest part of the hips by a trained research coordinator. Results (waist measurement/hip measurement) will be coded dichotomously with individuals scoring a &quot;1&quot; whose WHR falls greater than or equal to one standard deviation above the mean of the sample. This scoring will also be included in the larger allostatic load risk ratio.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Heart Rate (HR)</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via pulse taken by a trained nurse. Results will be coded dichotomously with individuals scoring a &quot;1&quot; whose HR falls greater than or equal to one standard deviation above the mean of the sample. This scoring will also be included in the larger allostatic load risk ratio.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Intensity</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via numeric rating scale (range: 0-10). Higher rating indicates more intense pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Disability</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via self-report Functional Disability Inventory (range: 0-60). Higher rating indicates greater functional disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via Patient Reported Outcome Measurement Information System (PROMIS) sleep disturbance scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater impairment in sleep.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Treatment Engagement</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via participant self-report of treatment as usual (e.g., engagement in physical therapy, cognitive-behavioral therapy, acupuncture, etc.). Observational measure without metrics for risk or impairment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Adverse Childhood Experiences (ACEs) exposure</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via Childhood Trust Events Scale (CTES). Items on this measure are coded dichotomously (0 = no; 1 = yes) and will be summed to provide a total metric of ACEs exposure (range: 0-26).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Psychological Stress</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via Patient Reported Outcome Measurement Information System (PROMIS) psychological stress scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of psychological stress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Anxiety</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via Patient Reported Outcome Measurement Information System (PROMIS) anxiety scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of anxiety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Depression</measure>
    <time_frame>baseline and 4-month follow-up</time_frame>
    <description>measured via Patient Reported Outcome Measurement Information System (PROMIS) depression scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of depressive symptoms.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Chronic Widespread Pain</condition>
  <condition>Stress, Psychological</condition>
  <condition>Stress, Physiological</condition>
  <arm_group>
    <arm_group_label>Study Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants enrolled in the study will undergo baseline fMRI and baseline and follow-up (4-month post-baseline) assessment of stress physiology (i.e., allostatic load). Treatment as usual information will be gathered for all participants to assess observational intervention response.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>functional Magnetic Resonance Imaging (fMRI)</intervention_name>
    <description>Participants will undergo a one hour fMRI scan with pain-induction using heat-based QST protocol.</description>
    <arm_group_label>Study Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Allostatic Load Composite</intervention_name>
    <description>All participants will be asked to provide saliva samples to measure cortisol response over time and dehydroepiandrosterone (DHEA) in addition to physiological measurements such as blood pressure/pulse, height/weight, and waist-hip ratio. Measurements will be taken at baseline and 4-month follow-up.</description>
    <arm_group_label>Study Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Chronic Widespread Pain (CWP) group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Between ages 11-17 years&#xD;
&#xD;
          -  Referred to the Boston Children's Hospital Pain Treatment Service for evaluation of a&#xD;
             CWP condition with duration &gt; 3 months&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak sufficient English to complete questionnaires&#xD;
&#xD;
          -  Severe cognitive impairment&#xD;
&#xD;
          -  Prescription steroidal (interference with cortisol measures) or psychotropic&#xD;
             medication&#xD;
&#xD;
          -  Any other chronic pain diagnosis (e.g., migraines, abdominal pain, CRPS)&#xD;
&#xD;
          -  fMRI contraindications (e.g., dental appliances)&#xD;
&#xD;
        Healthy Control (HC) group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Between ages 11-17 years&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak sufficient English to complete questionnaires&#xD;
&#xD;
          -  Severe cognitive impairment&#xD;
&#xD;
          -  Prescription steroidal (interference with cortisol measures) or psychotropic&#xD;
             medication&#xD;
&#xD;
          -  Any chronic pain diagnosis&#xD;
&#xD;
          -  Presence of documented chronic (&gt; 3 months) medical condition with an identifiable,&#xD;
             organic cause (e.g., diabetes, cystic fibrosis)&#xD;
&#xD;
          -  fMRI contraindications (e.g., dental appliances)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Nelson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital/Harvard Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarah Nelson, PhD</last_name>
    <phone>6173557040</phone>
    <email>sarah.nelson@childrens.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ayeong Kim</last_name>
    </contact>
    <investigator>
      <last_name>Sarah Nelson, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Sarah Nelson</investigator_full_name>
    <investigator_title>Assistant Professor and Attending Psychologist</investigator_title>
  </responsible_party>
  <keyword>Chronic Widespread Pain</keyword>
  <keyword>Pediatric Pain</keyword>
  <keyword>Allostatic Load</keyword>
  <keyword>fMRI</keyword>
  <keyword>Mind-Body Interventions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Dr. Nelson and collaborators acknowledge their willingness to share data and materials with other eligible investigators through academically established means.&#xD;
Finalized data sets will be available to other researchers who seek to conduct further analysis on any and all variables of the study, in full compliance with HIPAA and institutional IRB oversight. Interested researchers would need the permission of the PI of this study (Nelson). Any data-sharing agreement would include the purpose of the secondary analyses and the credentials of the researchers, and will be in full HIPAA compliance, as the data will be de-identified. This data-sharing agreement will meet the NIH's policy for data sharing.</ipd_description>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be made available on a case-by-case basis.</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04488757
org study id: IRB-P00035303
secondary id: 1K23AT010643-01A1
nct id: NCT04488757
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic widespread pain (CWP) is a common chronic pain condition in youth and often
      associated with significant pain-related and psychosocial impairment. Understanding the
      neurobiological mechanisms that may underlie pediatric chronic pain and pain-related
      impairment can inform future treatments to ameliorate patients' suffering, making it a
      critical area of empirical investigation.
Pediatric chronic widespread pain (CWP) is a serious public health problem resulting in high
      levels of healthcare utilization and disability. Youth with CWP also frequently report
      exposure to adverse childhood experiences (ACEs; abuse/neglect, violent/conflictual home
      environment, etc.) and a significant subset continue to experience physical and psychosocial
      impairment long-term. Certain mind-body interventions such as mindfulness-based stress
      reduction (MBSR) or meditation may be particularly appropriate for youth with CWP as they
      have been shown to modulate stress-induced maladaptation of the HPA-axis, autonomic nervous
      system, cardiovascular system, and brain structure (e.g., hippocampus). However, it is
      currently unknown if these targets are affected in youth with CWP. Preliminary research
      indicates that allostatic load (AL), or "wear and tear" on the nervous system due to stress,
      may contribute to pain chronicity. Similarly, evidence suggests that the hippocampus, a brain
      structure that is among the most deleteriously affected by stress, plays a role in pain
      perception. However, no study to-date has examined AL and hippocampal functioning in relation
      to stress exposure in youth with CWP. Mind-body interventions such as MBSR or meditation are
      an important and safe therapy option for both pain and stress reduction in youth with CWP and
      may modulate the negative impact of ACEs, so there is a critical need to know if these
      mechanisms are engaged in this population. The current study utilizes multifactorial
      physiological and neuroimaging measurement techniques to enhance our understanding of the
      potential role of these mechanisms in pain-related impairment and responsiveness to mind-body
      interventions over time. The aims of this study are to better characterize AL, assessed via a
      multifactorial composite, and hippocampal functioning via fMRI in pediatric CWP as specific
      targets for mind-body interventions that can lead to treatment optimization and improved
      compliance.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants will undergo fMRI and stress physiology measurement. Intervention outcomes will be compared across two groups: 1. pediatric chronic widespread pain and 2. age and gender matched healthy controls.
primary purpose: Treatment
masking: None (Open Label)
measure: Hippocampal Functioning
time frame: baseline
description: measured via fMRI
measure: Change in Morning Cortisol
time frame: baseline and 4-month follow-up
description: measured via 2 samples of saliva taken via passive drool over the course of two days. After analysis, morning cortisol will be dichotomously coded with participants receiving a "1" if they score over one standard deviation above the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.
measure: Change in Dehydroepiandrosterone (DHEA)
time frame: baseline and 4-month follow-up
description: measured via 2 samples of saliva taken via passive drool over the course of two days. After analysis, DHEA will be dichotomously coded with participants receiving a "1" if they score over one standard deviation above the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.
measure: Change in Flattened Cortisol
time frame: baseline and 4-month follow-up
description: measured via 10 samples of saliva taken via passive drool over the course of two days. After analysis, the presence of cortisol will be dichotomously coded with participants receiving a "1" if the change in cortisol levels across the day fell at or below one standard deviation below the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.
measure: Change in Blood Pressure
time frame: baseline and 4-month follow-up
description: measured via blood pressure cuff by trained nurse. Results will be coded to capture levels that fall in the "normal", "prehypertension" and "hypertension" range with individuals scoring in the latter two ranges receiving a coding of "1" to be included in the allostatic load risk composite measure. Scoring of blood pressure ranges will be done using ezbmi- calculates deviation from expected BP/BMI by age/gender.
measure: Change in Body-Mass Index (BMI)
time frame: baseline and 4-month follow-up
description: measured via height and weight (in cm and kg) by a trained nurse. Results will be coded to capture individuals that score in the "underweight", "normal", "overweight" and "obese" ranges with individuals falling in all categories but "normal" receiving a coding of "1" to be included in the allostatic load risk ratio. Scoring of BMI ranges will be done using ezbmi- calculates deviation from expected BP/BMI by age/gender.
measure: Change in Waist-Hip Ratio (WHR)
time frame: baseline and 4-month follow-up
description: measured via tape measure around the smallest part of the waist and the widest part of the hips by a trained research coordinator. Results (waist measurement/hip measurement) will be coded dichotomously with individuals scoring a "1" whose WHR falls greater than or equal to one standard deviation above the mean of the sample. This scoring will also be included in the larger allostatic load risk ratio.
measure: Change in Heart Rate (HR)
time frame: baseline and 4-month follow-up
description: measured via pulse taken by a trained nurse. Results will be coded dichotomously with individuals scoring a "1" whose HR falls greater than or equal to one standard deviation above the mean of the sample. This scoring will also be included in the larger allostatic load risk ratio.
measure: Change in Pain Intensity
time frame: baseline and 4-month follow-up
description: measured via numeric rating scale (range: 0-10). Higher rating indicates more intense pain.
measure: Change in Functional Disability
time frame: baseline and 4-month follow-up
description: measured via self-report Functional Disability Inventory (range: 0-60). Higher rating indicates greater functional disability.
measure: Change in Sleep
time frame: baseline and 4-month follow-up
description: measured via Patient Reported Outcome Measurement Information System (PROMIS) sleep disturbance scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater impairment in sleep.
measure: Change in Treatment Engagement
time frame: baseline and 4-month follow-up
description: measured via participant self-report of treatment as usual (e.g., engagement in physical therapy, cognitive-behavioral therapy, acupuncture, etc.). Observational measure without metrics for risk or impairment.
measure: Change in Adverse Childhood Experiences (ACEs) exposure
time frame: baseline and 4-month follow-up
description: measured via Childhood Trust Events Scale (CTES). Items on this measure are coded dichotomously (0 = no; 1 = yes) and will be summed to provide a total metric of ACEs exposure (range: 0-26).
measure: Change in Psychological Stress
time frame: baseline and 4-month follow-up
description: measured via Patient Reported Outcome Measurement Information System (PROMIS) psychological stress scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of psychological stress.
measure: Change in Anxiety
time frame: baseline and 4-month follow-up
description: measured via Patient Reported Outcome Measurement Information System (PROMIS) anxiety scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of anxiety.
measure: Change in Depression
time frame: baseline and 4-month follow-up
description: measured via Patient Reported Outcome Measurement Information System (PROMIS) depression scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of depressive symptoms.
arm group label: Study Arm
arm group type: Other
description: All participants enrolled in the study will undergo baseline fMRI and baseline and follow-up (4-month post-baseline) assessment of stress physiology (i.e., allostatic load). Treatment as usual information will be gathered for all participants to assess observational intervention response.
intervention type: Diagnostic Test
intervention name: functional Magnetic Resonance Imaging (fMRI)
description: Participants will undergo a one hour fMRI scan with pain-induction using heat-based QST protocol.
arm group label: Study Arm
intervention type: Other
intervention name: Allostatic Load Composite
description: All participants will be asked to provide saliva samples to measure cortisol response over time and dehydroepiandrosterone (DHEA) in addition to physiological measurements such as blood pressure/pulse, height/weight, and waist-hip ratio. Measurements will be taken at baseline and 4-month follow-up.
arm group label: Study Arm
criteria: 
gender: All
minimum age: 11 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Nelson
role: Principal Investigator
affiliation: Boston Children's Hospital/Harvard Medical School
last name: Sarah Nelson, PhD
phone: 6173557040
email: sarah.nelson@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Sarah Nelson
investigator title: Assistant Professor and Attending Psychologist
mesh term: Chronic Pain
mesh term: Stress, Psychological
sharing ipd: Yes
ipd description: Dr. Nelson and collaborators acknowledge their willingness to share data and materials with other eligible investigators through academically established means.
Finalized data sets will be available to other researchers who seek to conduct further analysis on any and all variables of the study, in full compliance with HIPAA and institutional IRB oversight. Interested researchers would need the permission of the PI of this study (Nelson). Any data-sharing agreement would include the purpose of the secondary analyses and the credentials of the researchers, and will be in full HIPAA compliance, as the data will be de-identified. This data-sharing agreement will meet the NIH's policy for data sharing.
ipd info type: Analytic Code
ipd time frame: Data will be made available on a case-by-case basis.