<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/NCT03022643</url>
  </required_header>
  <id_info>
    <org_study_id>094507</org_study_id>
    <nct_id>NCT03022643</nct_id>
  </id_info>
  <brief_title>Social &amp; Behavioral Rhythms in Chronic Pain</brief_title>
  <official_title>Social &amp; Behavioral Rhythms in Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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>
      Behavioral and biological rhythms are essential for health. No study evaluated behavioral&#xD;
      rhythm or rhythm regulation in chronic pain and how this impacts functioning. The objective&#xD;
      of this study is to gather preliminary data, focusing on the role of behavioral rhythms in&#xD;
      the cardinal clinical symptoms of chronic pain (i.e., sleep, fatigue, and mood).&#xD;
      Additionally, this study will provide preliminary data for the feasibility and acceptability&#xD;
      of the therapeutic approach aiming to strengthen behavioral rhythms for patients with chronic&#xD;
      pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this study is to gather preliminary data, focusing on behavioral rhythms&#xD;
      in patients with chronic pain as well as the relationship between behavioral rhythms and the&#xD;
      pain-related clinical symptoms. Additionally, this study will provide preliminary data for&#xD;
      the feasibility, acceptability, and treatment effects of repurposing interpersonal social&#xD;
      rhythm therapy (IPSRT) along with light therapy for patients with chronic pain exhibiting&#xD;
      significant rhythm dysregulation, sleep disturbances, and mood symptoms. The deliverables at&#xD;
      the end of this project will include 1) preliminary evidence concerning the prevalence of&#xD;
      behavioral rhythm disturbances in patients with chronic pain; 2) the association between such&#xD;
      behavioral rhythm disruptions and the symptom cluster of pain-sleep-fatigue-mood; 3)&#xD;
      feasibility and acceptability of a prototype IPSRT repurposed for chronic pain patients along&#xD;
      with bright light therapy. The specific aims of this proposed study are as follows:&#xD;
&#xD;
      Aim 1: To evaluate regularity of social and behavioral rhythms (SBR), disruption of circadian&#xD;
      activity rhythms (CAR), and the relationship of SBR and CAR with clinical symptoms of&#xD;
      pain-sleep-fatigue-mood in chronic pain patients compared to healthy control.&#xD;
&#xD;
      Hypothesis 1: Patients with chronic pain will show high degrees of SBR and CAR disruption&#xD;
      compared to controls.&#xD;
&#xD;
      Hypothesis 2: Patients with increasingly dysregulated SBR and attenuated CAR will exhibit&#xD;
      worse clinical symptoms.&#xD;
&#xD;
      Hypothesis 3: SBR will be associated with CAR in patients with chronic pain and in controls.&#xD;
&#xD;
      Aim 2: To assess feasibility and acceptance of interpersonal social rhythm therapy repurposed&#xD;
      for chronic pain patient population along with bright light therapy provided to patients&#xD;
      exhibiting SBR disruption with significant sleep and mood symptoms.&#xD;
&#xD;
      Hypothesis 1: The IPSRT will be well tolerated and accepted by the patients&#xD;
&#xD;
      Hypothesis 2: Descriptive data will suggest improvement of SBR, CAR, and the pain-related&#xD;
      symptoms and functioning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Activity Rhythms - Actigraphy Assessment</measure>
    <time_frame>Baseline</time_frame>
    <description>Collected continuously for 8 days at baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Activity Rhythms - Actigraphy Assessment</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected continuously for 8 days at baseline, at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity index</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Rhythms Metric</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected continuously at baseline (during the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Disturbances: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Sleep disturbance</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep-Related Impairment: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for sleep related impairment</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Fatigue</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Depression</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Anxiety</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Behavior: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Pain behavior</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Interference: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for pain interference</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Functioning: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for physical functioning</measure>
    <time_frame>Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)</time_frame>
    <description>Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Pain Patients</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>40 Pain Patients will be screened for social and behavioral rhythms with no treatment involved. All patients will be evaluated an Actigraph by Philips for 8-days to assess sleep and activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>40 Controls will be screened for social and behavioral rhythms with no treatment involved. All Controls will be evaluated an Actigraph by Philips for 8-days to assess sleep and activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 patients from the original 40 will receive Interpersonal Social Rhythms Psychotherapy and Bright Light Device therapy to improve social and behavioral rhythms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interpersonal Social Rhythms Psychotherapy</intervention_name>
    <description>The treatment involves 8-weeks of individual psychotherapy. Weekly sessions will be 60-minute long and will take place at the Pain Research Center. The treatment focuses on 1) the link between life events, pain severity, sleep disturbances, fatigue, and mood, 2) social and behavioral rhythms and sleep-wake disturbances, 3) identification and management of rhythm dysregulation and the triggers for it, 4) allowing and facilitating the mourning of the loss healthy self, 5) identification and appropriate management of symptoms.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bright Light Device</intervention_name>
    <description>All patients will be provided with a bright light device (Re-Timer) and will be instructed to use it in the first 2-hours of the day (for a minimum of 30 minutes) throughout the 8-week treatment period.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Re-Timer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants (patients and controls):&#xD;
&#xD;
          -  18-65 years of age with&#xD;
&#xD;
          -  reading/writing proficiency in English.&#xD;
&#xD;
        Aim 1:&#xD;
&#xD;
        Patients must:&#xD;
&#xD;
          -  have had persistent pain for more than 1-year at a consistent body part or diffuse&#xD;
             body pain (e.g., fibromyalgia) that is stable rather than progressive in nature&#xD;
&#xD;
          -  report experiencing pain for more than 70% of the waking hours in any given week&#xD;
&#xD;
          -  under current medical care by a physician for a pain diagnosis&#xD;
&#xD;
          -  able remain stable on any of their medication (as prescribed) for the duration of the&#xD;
             8-day evaluation involved in Aim 1&#xD;
&#xD;
        Control subjects must:&#xD;
&#xD;
          -  be pain-free for the past 1-year&#xD;
&#xD;
          -  no prior treatment for a chronic pain condition&#xD;
&#xD;
          -  in overall good health&#xD;
&#xD;
        Aim 2:&#xD;
&#xD;
        Patients must:&#xD;
&#xD;
          -  have current symptoms of insomnia (Insomnia Severity Index (ISI), ISI&gt;8)&#xD;
&#xD;
          -  have depression (Patient Health Questionnaire-9, PHQ-9&gt;10)&#xD;
&#xD;
          -  exhibit significant circadian activity rhythm dysregulation during the 8-day&#xD;
             evaluation (defined as Amplitude&lt;0.9)&#xD;
&#xD;
        Control subjects must:&#xD;
&#xD;
          -  be pain-free for the past 1-year&#xD;
&#xD;
          -  no prior treatment for a chronic pain condition&#xD;
&#xD;
          -  in overall good health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Aim 1:&#xD;
&#xD;
          -  patients/controls who underwent surgery in the last 6-months&#xD;
&#xD;
          -  shift workers&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  current drug abuse/dependence&#xD;
&#xD;
          -  receiving treatment in methadone clinic&#xD;
&#xD;
          -  current cardiac conditions&#xD;
&#xD;
          -  untreated sleep apnea&#xD;
&#xD;
          -  untreated restless legs syndrome&#xD;
&#xD;
          -  neurodegenerative disease&#xD;
&#xD;
          -  bipolar disorder&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  suicidal ideation&#xD;
&#xD;
          -  have changed time-zones in the last 7 days&#xD;
&#xD;
          -  experienced a significant life change in the last month (e.g., death in the family,&#xD;
             loss of job, traumatic event)&#xD;
&#xD;
        Aim 2:&#xD;
&#xD;
          -  patients/controls who underwent surgery in the last 6-months&#xD;
&#xD;
          -  shift workers&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  current drug abuse/dependence&#xD;
&#xD;
          -  receiving treatment in methadone clinic&#xD;
&#xD;
          -  current cardiac conditions&#xD;
&#xD;
          -  untreated sleep apnea&#xD;
&#xD;
          -  untreated restless legs syndrome&#xD;
&#xD;
          -  neurodegenerative disease&#xD;
&#xD;
          -  bipolar disorder&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  suicidal ideation&#xD;
&#xD;
          -  have changed time-zones in the last 7 days&#xD;
&#xD;
          -  experienced a significant life change in the last month (e.g., death in the family,&#xD;
             loss of job, traumatic event)&#xD;
&#xD;
          -  receiving psychotherapy&#xD;
&#xD;
          -  significant photophobia&#xD;
&#xD;
          -  chronic migraines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ariel B Neikrug, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>March 13, 2019</last_update_submitted>
  <last_update_submitted_qc>March 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Ariel Neikrug</investigator_full_name>
    <investigator_title>Postdoctoral Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03022643
org study id: 094507
nct id: NCT03022643
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Behavioral and biological rhythms are essential for health. No study evaluated behavioral
      rhythm or rhythm regulation in chronic pain and how this impacts functioning. The objective
      of this study is to gather preliminary data, focusing on the role of behavioral rhythms in
      the cardinal clinical symptoms of chronic pain (i.e., sleep, fatigue, and mood).
      Additionally, this study will provide preliminary data for the feasibility and acceptability
      of the therapeutic approach aiming to strengthen behavioral rhythms for patients with chronic
      pain.
The overall goal of this study is to gather preliminary data, focusing on behavioral rhythms
      in patients with chronic pain as well as the relationship between behavioral rhythms and the
      pain-related clinical symptoms. Additionally, this study will provide preliminary data for
      the feasibility, acceptability, and treatment effects of repurposing interpersonal social
      rhythm therapy (IPSRT) along with light therapy for patients with chronic pain exhibiting
      significant rhythm dysregulation, sleep disturbances, and mood symptoms. The deliverables at
      the end of this project will include 1) preliminary evidence concerning the prevalence of
      behavioral rhythm disturbances in patients with chronic pain; 2) the association between such
      behavioral rhythm disruptions and the symptom cluster of pain-sleep-fatigue-mood; 3)
      feasibility and acceptability of a prototype IPSRT repurposed for chronic pain patients along
      with bright light therapy. The specific aims of this proposed study are as follows:

      Aim 1: To evaluate regularity of social and behavioral rhythms (SBR), disruption of circadian
      activity rhythms (CAR), and the relationship of SBR and CAR with clinical symptoms of
      pain-sleep-fatigue-mood in chronic pain patients compared to healthy control.

      Hypothesis 1: Patients with chronic pain will show high degrees of SBR and CAR disruption
      compared to controls.

      Hypothesis 2: Patients with increasingly dysregulated SBR and attenuated CAR will exhibit
      worse clinical symptoms.

      Hypothesis 3: SBR will be associated with CAR in patients with chronic pain and in controls.

      Aim 2: To assess feasibility and acceptance of interpersonal social rhythm therapy repurposed
      for chronic pain patient population along with bright light therapy provided to patients
      exhibiting SBR disruption with significant sleep and mood symptoms.

      Hypothesis 1: The IPSRT will be well tolerated and accepted by the patients

      Hypothesis 2: Descriptive data will suggest improvement of SBR, CAR, and the pain-related
      symptoms and functioning.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Activity Rhythms - Actigraphy Assessment
time frame: Baseline
description: Collected continuously for 8 days at baseline
measure: Change in Activity Rhythms - Actigraphy Assessment
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected continuously for 8 days at baseline, at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Insomnia Severity index
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Social Rhythms Metric
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected continuously at baseline (during the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Sleep Disturbances: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Sleep disturbance
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Sleep-Related Impairment: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for sleep related impairment
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Fatigue: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Fatigue
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Depression: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Depression
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Anxiety: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Anxiety
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Pain Behavior: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Pain behavior
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Pain Interference: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for pain interference
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
measure: Physical Functioning: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for physical functioning
time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
description: Collected at baseline (prior the 8-day assessment), at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
arm group label: Pain Patients
arm group type: No Intervention
description: 40 Pain Patients will be screened for social and behavioral rhythms with no treatment involved. All patients will be evaluated an Actigraph by Philips for 8-days to assess sleep and activity.
arm group label: Controls
arm group type: No Intervention
description: 40 Controls will be screened for social and behavioral rhythms with no treatment involved. All Controls will be evaluated an Actigraph by Philips for 8-days to assess sleep and activity.
arm group label: Treatment
arm group type: Experimental
description: 10 patients from the original 40 will receive Interpersonal Social Rhythms Psychotherapy and Bright Light Device therapy to improve social and behavioral rhythms.
intervention type: Behavioral
intervention name: Interpersonal Social Rhythms Psychotherapy
description: The treatment involves 8-weeks of individual psychotherapy. Weekly sessions will be 60-minute long and will take place at the Pain Research Center. The treatment focuses on 1) the link between life events, pain severity, sleep disturbances, fatigue, and mood, 2) social and behavioral rhythms and sleep-wake disturbances, 3) identification and management of rhythm dysregulation and the triggers for it, 4) allowing and facilitating the mourning of the loss healthy self, 5) identification and appropriate management of symptoms.
arm group label: Treatment
intervention type: Other
intervention name: Bright Light Device
description: All patients will be provided with a bright light device (Re-Timer) and will be instructed to use it in the first 2-hours of the day (for a minimum of 30 minutes) throughout the 8-week treatment period.
arm group label: Treatment
other name: Re-Timer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ariel B Neikrug, PhD
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Ariel Neikrug
investigator title: Postdoctoral Fellow
mesh term: Chronic Pain
sharing ipd: No