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/NCT05963607</url>
    </required_header>
    <id_info>
      <org_study_id>NURP-005-22F</org_study_id>
      <secondary_id>I01CX002591</secondary_id>
      <nct_id>NCT05963607</nct_id>
    </id_info>
    <brief_title>RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain</brief_title>
    <acronym>WB</acronym>
    <official_title>RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chronic pain is a major health concern for returning Veterans and is associated with&#xD;
        decreases in quality of life. In addition, chronic pain is often accompanied by significant&#xD;
        disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools&#xD;
        for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn&#xD;
        with weighted material inside to provide widespread pressure to the body- are a low-cost&#xD;
        wellness product used for anxiety and sleep. WBs have demonstrated large reductions in&#xD;
        insomnia, and the investigators have also shown that they can reduce the severity of chronic&#xD;
        pain. However, effects and mechanisms of longer WB use have not been examined in individuals&#xD;
        with pain and sleep disturbance. The investigators therefore propose a randomized controlled&#xD;
        trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators&#xD;
        will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego&#xD;
        Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160&#xD;
        Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The&#xD;
        investigators will remotely collect measures of pain (primary), pain catastrophizing, and&#xD;
        pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total&#xD;
        sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will&#xD;
        also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in&#xD;
        VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via&#xD;
        smartphone to capture study adherence.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic pain is a major health concern for returning Veterans15 and is associated with&#xD;
        decreases in quality of life16, increased opioid use/misuse and self-injury17,18, and&#xD;
        significant emotional toll on the patient and medical provider19. The management of pain is a&#xD;
        high priority for the Veterans Administration (VA)20 and VA primary care providers21. In&#xD;
        addition, chronic pain is highly comorbid with significant disturbance in sleep22, and sleep&#xD;
        fragmentation and poor sleep, in turn, are associated with increases in pain sensitivity and&#xD;
        pain interference23,24. Decreasing sleep disturbance among Veterans with chronic pain&#xD;
        therefore has the potential to greatly reduce pain22, ultimately improving quality of life.&#xD;
  &#xD;
        Sensory interventions may offer effective, low-cost complementary tools for chronic pain and&#xD;
        sleep disturbance in Veterans. Deep pressure is pleasant and calming25, and reduces acute&#xD;
        pain8 and anxiety25 in healthy adults. Weighted Blankets (WB)- blankets sewn with weighted&#xD;
        material inside to provide widespread pressure to the body- are a low-cost wellness product&#xD;
        used for anxiety and sleep. WBs have demonstrated large reductions in insomnia in individuals&#xD;
        with (Cohen's d = 1.9)11 and without12 psychiatric disorders, as well as significant&#xD;
        reductions in anxiety and sympathetic arousal26. Tm nl;phe investigators have demonstrated&#xD;
        that 1-week of overnight WB use can also reduce chronic pain (severity/interference)27.&#xD;
        However, effects and mechanisms of longer WB use have not been examined in individuals with&#xD;
        pain and sleep disturbance. The investigators posit that pressure from a WB reduces pain and&#xD;
        anxiety while falling asleep and sleeping, decreasing sleep fragmentation and sleep&#xD;
        disturbance overnight and, in turn, decreasing pain and pain catastrophizing. The&#xD;
        investigators therefore propose a randomized controlled trial examining the effects of WBs on&#xD;
        pain and sleep quality in Veterans.&#xD;
  &#xD;
        The two objectives of this CSR&amp;D Merit Review are to determine whether in Veterans with&#xD;
        musculoskeletal chronic pain and sleep disturbance, a heavy WB versus light (control) blanket&#xD;
        will reduce pain impact (severity/interference) and sleep disturbance, and whether&#xD;
        improvements in sleep mediate such reductions in pain. The investigators will recruit&#xD;
        Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System&#xD;
        (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to&#xD;
        receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators&#xD;
        will collect measures of pain (primary), pain catastrophizing, and pain medication use, as&#xD;
        well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of&#xD;
        overnight use of the assigned blanket. The investigators will also explore physiological&#xD;
        effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants.&#xD;
        Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture&#xD;
        study adherence. Our central hypothesis is that although both study arms will be associated&#xD;
        with positive clinical outcomes, deeper pressure from the WB will be associated with&#xD;
        significantly greater reductions in pain impact and sleep disturbance, with improvements in&#xD;
        sleep mediating reductions in pain. The investigators will examine the following aims:&#xD;
  &#xD;
        Aim1: Compare the efficacy of a WB versus control blanket on pain in Veterans with&#xD;
        musculoskeletal chronic pain and sleep disturbance. Hypothesis 1a: Pain impact (severity and&#xD;
        interference) measured by the Pain, Enjoyment of Life, and General Activity (PEG) Scale28&#xD;
        (primary outcome) and pain catastrophizing (Pain Catastrophizing Scale; PCS)29 will show&#xD;
        significantly greater improvement in a group of Veterans with chronic pain over 6 weeks from&#xD;
        nightly use of a 15-lb versus 3-lb blanket. Hypothesis 1b: Veterans with chronic pain using&#xD;
        the 15-lb versus 3-lb blanket will show significantly greater reductions in pain medication&#xD;
        use. Exploratory Hypothesis 1c: Pain impact of 15 vs 3-lb blanket will remain higher 12-weeks&#xD;
        after randomization.&#xD;
  &#xD;
        Aim2: Compare the efficacy of a WB versus control blanket on sleep disturbance in Veterans&#xD;
        with musculoskeletal chronic pain and sleep disturbance. Hypothesis 2a: Veterans using the&#xD;
        15-lb versus 3-lb blanket will show significantly greater improvement in sleep disturbance&#xD;
        (Insomnia Severity Index; ISI30; primary outcome measure) and sleep efficiency and total&#xD;
        sleep time (Daily Sleep Diary31,32) over 6 weeks of use of a 15-lb versus 3-lb blanket.&#xD;
        Exploratory Hypothesis 2b: Veterans using the 15-lb versus 3-lb blanket will show increased&#xD;
        sleep efficiency and total sleep time (measured by actigraphy) after six weeks of use.&#xD;
  &#xD;
        Aim3: Examine the mediation effect of sleep on pain. Hypothesis 3a: Decreases in sleep&#xD;
        disturbance (Insomnia Severity Index; ISI30) will mediate reductions in pain impact (PEG28)&#xD;
        over the 6-week intervention. Exploratory Hypothesis 3b: Improvements in sleep efficiency&#xD;
        (actigraphy) will mediate reductions in PEG pain.&#xD;
  &#xD;
        Our expected outcomes are to identify the effects of a WB on chronic pain and sleep&#xD;
        disturbance, and the relationship between these clinical factors. The proposed research&#xD;
        findings will have a positive impact by providing evidence for effects on chronic pain and&#xD;
        sleep disturbance for this novel, accessible and fully remote intervention. Study results&#xD;
        will inform both future research and treatment of chronic pain.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">April 1, 2024</start_date>
    <completion_date type="Anticipated">September 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2029</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized controlled study with two study arms.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Participants will be masked to study group to the extent possible (blanket weights are self-evident). Data will be collected online/remotely with no interaction from the study team except for study reminders or technical assistance.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain impact change</measure>
      <time_frame>Weeks 0, 2, 4, and 6</time_frame>
      <description>Pain impact (severity and interference) will be measured by the Pain, Enjoyment of Life, and General Activity (PEG) Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep disturbance change</measure>
      <time_frame>Weeks 0, 2, 4, and 6</time_frame>
      <description>Sleep disturbance will be measured by the Insomnia Severity Index (ISI)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain catastrophizing</measure>
      <time_frame>Weeks 0, 2, 4, and 6</time_frame>
      <description>Pain catastrophizing will be measured by the Pain Catastrophizing Scale (PCS).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain medication use</measure>
      <time_frame>Weeks 0, 2, 4, and 6</time_frame>
      <description>Participants will be asked to self report their current pain medication use including prescribed pain medications, dose, and frequency. Prescriptions will be verified with VA electronic health records. Change in pain medications will be quantified as a percent in daily dose from baseline (if multiple pain medications are prescribed, percent change will be averaged across all pain medications). Opioids will be standardized in morphine milligram equivalents.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily Sleep Diary</measure>
      <time_frame>Weeks 0, 2, 4, and 6</time_frame>
      <description>This 12-item scale measures sleep efficiency and total sleep time.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Chronic Pain</condition>
    <condition>Sleep Disturbance</condition>
    <arm_group>
      <arm_group_label>Heavy blanket</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wear heavy blanket overnight for 6 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Light blanket</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Wear light blanket overnight for 6 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Weighted blanket</intervention_name>
      <description>A blanket sewn with extra weight in it.</description>
      <arm_group_label>Heavy blanket</arm_group_label>
      <arm_group_label>Light blanket</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The inclusion/exclusion criteria are designed to be as inclusive as possible and to reflect&#xD;
          the heterogeneity of &quot;real-world&quot; Veterans referred to usual care, to maximize&#xD;
          generalizability:&#xD;
  &#xD;
            -  VA-enrolled&#xD;
  &#xD;
            -  All genders, ages 18 and older&#xD;
  &#xD;
            -  chronic non-cancer musculoskeletal pain diagnosis on 2 clinical visits for at least 6&#xD;
               months (ICD codes for chronic pain), and a score of 3 on the numerical pain rating&#xD;
               scale from 0-10 over the past week&#xD;
  &#xD;
            -  sleep disturbance measured by a score &gt;= 11 on the ISI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Exclusion criteria: Exclusion criteria include only those factors that contraindicate usual&#xD;
          treatment for chronic pain, that prevent the Veteran from benefiting from study treatments,&#xD;
          or that may interfere with the mechanisms under study:&#xD;
  &#xD;
            -  Serious or untreated mental illness (e.g., psychosis; PTSD will not be excluded),&#xD;
  &#xD;
            -  other psychosocial instability (e.g., homelessness), or&#xD;
  &#xD;
            -  suicidal/homicidal ideation/prior attempt within the past 3 years by the&#xD;
               Mini-International Neuropsychiatric Interview (MINI)19;&#xD;
  &#xD;
            -  evidence of opioid use disorder by chart review, or a Current Opioid Misuse Measure&#xD;
               (COMM20) score of 9 or both;&#xD;
  &#xD;
            -  major medical conditions or medical counterindications to use of a 15-lb WB (e.g.,&#xD;
               self-reported or documented current pregnancy;&#xD;
  &#xD;
            -  claustrophobia;&#xD;
  &#xD;
            -  spinal cord injury;&#xD;
  &#xD;
            -  inability to safely lift 15lb);&#xD;
  &#xD;
            -  obstructive sleep apnea if untreated, OR STOP-BANG score in &quot;high-risk&quot; category; and&#xD;
  &#xD;
            -  currently sleeping with a special blanket (such as weighted or cooling blanket).&#xD;
  &#xD;
            -  Those receiving mental health or other pain treatment will be excluded if there are&#xD;
               changes to treatment (either therapy or medications) in the 3 months prior to&#xD;
               enrollment or anticipated during the 2-month trial (self-report, confirmed as possible&#xD;
               in electronic health record).&#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>Laura K Case, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA San Diego Healthcare System, San Diego, CA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laura K Case, PhD</last_name>
      <phone>(858) 642-3657</phone>
      <email>laura.case@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Irina Strigo, PhD</last_name>
      <phone>(415) 221-4810</phone>
      <phone_ext>25138</phone_ext>
      <email>irina.strigo@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>VA San Diego Healthcare System, San Diego, CA</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92161-0002</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Gerhard H Schulteis, PhD</last_name>
        <phone>858-642-3657</phone>
        <email>gerhard.schulteis@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Alan Simmons, PhD</last_name>
        <phone>(858) 552-8585</phone>
        <phone_ext>2521</phone_ext>
        <email>ansimmons@ucsd.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Laura K Case, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>San Francisco VA Medical Center, San Francisco, CA</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94121-1563</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jennifer Mitchell, PhD</last_name>
        <phone>415-221-4810</phone>
        <email>jennifer.mitchell@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Rebecca Yu, BA</last_name>
        <phone>4152214810</phone>
        <phone_ext>23687</phone_ext>
        <email>rebecca.yu@va.gov</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>chronic pain</keyword>
    <keyword>sleep</keyword>
    <keyword>weighted blanket</keyword>
    <keyword>mood</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyssomnias</mesh_term>
      <mesh_term>Parasomnias</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Body Weight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05963607
  org study id: NURP-005-22F
  secondary id: I01CX002591
  nct id: NCT05963607
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Chronic pain is a major health concern for returning Veterans and is associated with
        decreases in quality of life. In addition, chronic pain is often accompanied by significant
        disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools
        for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn
        with weighted material inside to provide widespread pressure to the body- are a low-cost
        wellness product used for anxiety and sleep. WBs have demonstrated large reductions in
        insomnia, and the investigators have also shown that they can reduce the severity of chronic
        pain. However, effects and mechanisms of longer WB use have not been examined in individuals
        with pain and sleep disturbance. The investigators therefore propose a randomized controlled
        trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators
        will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego
        Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160
        Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The
        investigators will remotely collect measures of pain (primary), pain catastrophizing, and
        pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total
        sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will
        also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in
        VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via
        smartphone to capture study adherence.
  Chronic pain is a major health concern for returning Veterans15 and is associated with
        decreases in quality of life16, increased opioid use/misuse and self-injury17,18, and
        significant emotional toll on the patient and medical provider19. The management of pain is a
        high priority for the Veterans Administration (VA)20 and VA primary care providers21. In
        addition, chronic pain is highly comorbid with significant disturbance in sleep22, and sleep
        fragmentation and poor sleep, in turn, are associated with increases in pain sensitivity and
        pain interference23,24. Decreasing sleep disturbance among Veterans with chronic pain
        therefore has the potential to greatly reduce pain22, ultimately improving quality of life.
  
        Sensory interventions may offer effective, low-cost complementary tools for chronic pain and
        sleep disturbance in Veterans. Deep pressure is pleasant and calming25, and reduces acute
        pain8 and anxiety25 in healthy adults. Weighted Blankets (WB)- blankets sewn with weighted
        material inside to provide widespread pressure to the body- are a low-cost wellness product
        used for anxiety and sleep. WBs have demonstrated large reductions in insomnia in individuals
        with (Cohen's d = 1.9)11 and without12 psychiatric disorders, as well as significant
        reductions in anxiety and sympathetic arousal26. Tm nl;phe investigators have demonstrated
        that 1-week of overnight WB use can also reduce chronic pain (severity/interference)27.
        However, effects and mechanisms of longer WB use have not been examined in individuals with
        pain and sleep disturbance. The investigators posit that pressure from a WB reduces pain and
        anxiety while falling asleep and sleeping, decreasing sleep fragmentation and sleep
        disturbance overnight and, in turn, decreasing pain and pain catastrophizing. The
        investigators therefore propose a randomized controlled trial examining the effects of WBs on
        pain and sleep quality in Veterans.
  
        The two objectives of this CSR&D Merit Review are to determine whether in Veterans with
        musculoskeletal chronic pain and sleep disturbance, a heavy WB versus light (control) blanket
        will reduce pain impact (severity/interference) and sleep disturbance, and whether
        improvements in sleep mediate such reductions in pain. The investigators will recruit
        Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System
        (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to
        receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators
        will collect measures of pain (primary), pain catastrophizing, and pain medication use, as
        well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of
        overnight use of the assigned blanket. The investigators will also explore physiological
        effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants.
        Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture
        study adherence. Our central hypothesis is that although both study arms will be associated
        with positive clinical outcomes, deeper pressure from the WB will be associated with
        significantly greater reductions in pain impact and sleep disturbance, with improvements in
        sleep mediating reductions in pain. The investigators will examine the following aims:
  
        Aim1: Compare the efficacy of a WB versus control blanket on pain in Veterans with
        musculoskeletal chronic pain and sleep disturbance. Hypothesis 1a: Pain impact (severity and
        interference) measured by the Pain, Enjoyment of Life, and General Activity (PEG) Scale28
        (primary outcome) and pain catastrophizing (Pain Catastrophizing Scale; PCS)29 will show
        significantly greater improvement in a group of Veterans with chronic pain over 6 weeks from
        nightly use of a 15-lb versus 3-lb blanket. Hypothesis 1b: Veterans with chronic pain using
        the 15-lb versus 3-lb blanket will show significantly greater reductions in pain medication
        use. Exploratory Hypothesis 1c: Pain impact of 15 vs 3-lb blanket will remain higher 12-weeks
        after randomization.
  
        Aim2: Compare the efficacy of a WB versus control blanket on sleep disturbance in Veterans
        with musculoskeletal chronic pain and sleep disturbance. Hypothesis 2a: Veterans using the
        15-lb versus 3-lb blanket will show significantly greater improvement in sleep disturbance
        (Insomnia Severity Index; ISI30; primary outcome measure) and sleep efficiency and total
        sleep time (Daily Sleep Diary31,32) over 6 weeks of use of a 15-lb versus 3-lb blanket.
        Exploratory Hypothesis 2b: Veterans using the 15-lb versus 3-lb blanket will show increased
        sleep efficiency and total sleep time (measured by actigraphy) after six weeks of use.
  
        Aim3: Examine the mediation effect of sleep on pain. Hypothesis 3a: Decreases in sleep
        disturbance (Insomnia Severity Index; ISI30) will mediate reductions in pain impact (PEG28)
        over the 6-week intervention. Exploratory Hypothesis 3b: Improvements in sleep efficiency
        (actigraphy) will mediate reductions in PEG pain.
  
        Our expected outcomes are to identify the effects of a WB on chronic pain and sleep
        disturbance, and the relationship between these clinical factors. The proposed research
        findings will have a positive impact by providing evidence for effects on chronic pain and
        sleep disturbance for this novel, accessible and fully remote intervention. Study results
        will inform both future research and treatment of chronic pain.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled study with two study arms.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Participants will be masked to study group to the extent possible (blanket weights are self-evident). Data will be collected online/remotely with no interaction from the study team except for study reminders or technical assistance.
  measure: Pain impact change
  time frame: Weeks 0, 2, 4, and 6
  description: Pain impact (severity and interference) will be measured by the Pain, Enjoyment of Life, and General Activity (PEG) Scale
  measure: Sleep disturbance change
  time frame: Weeks 0, 2, 4, and 6
  description: Sleep disturbance will be measured by the Insomnia Severity Index (ISI)
  measure: Pain catastrophizing
  time frame: Weeks 0, 2, 4, and 6
  description: Pain catastrophizing will be measured by the Pain Catastrophizing Scale (PCS).
  measure: Pain medication use
  time frame: Weeks 0, 2, 4, and 6
  description: Participants will be asked to self report their current pain medication use including prescribed pain medications, dose, and frequency. Prescriptions will be verified with VA electronic health records. Change in pain medications will be quantified as a percent in daily dose from baseline (if multiple pain medications are prescribed, percent change will be averaged across all pain medications). Opioids will be standardized in morphine milligram equivalents.
  measure: Daily Sleep Diary
  time frame: Weeks 0, 2, 4, and 6
  description: This 12-item scale measures sleep efficiency and total sleep time.
  arm group label: Heavy blanket
  arm group type: Experimental
  description: Wear heavy blanket overnight for 6 weeks
  arm group label: Light blanket
  arm group type: Active Comparator
  description: Wear light blanket overnight for 6 weeks
  intervention type: Other
  intervention name: Weighted blanket
  description: A blanket sewn with extra weight in it.
  arm group label: Heavy blanket
  arm group label: Light blanket
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Laura K Case, PhD
  role: Principal Investigator
  affiliation: VA San Diego Healthcare System, San Diego, CA
  last name: Laura K Case, PhD
  phone: (858) 642-3657
  email: laura.case@va.gov
  last name: Irina Strigo, PhD
  phone: (415) 221-4810
  phone ext: 25138
  email: irina.strigo@va.gov
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Dyssomnias
  mesh term: Parasomnias
  mesh term: Chronic Pain
  mesh term: Body Weight
  sharing ipd: No