<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/NCT03012425</url>
  </required_header>
  <id_info>
    <org_study_id>17-001</org_study_id>
    <nct_id>NCT03012425</nct_id>
  </id_info>
  <brief_title>Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers</brief_title>
  <official_title>Pilot Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hunter College of City University of New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The other aim of this study is to determine which of those two treatments (acupuncture or&#xD;
      cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of&#xD;
      cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">October 23, 2020</completion_date>
  <primary_completion_date type="Actual">October 23, 2020</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of participants who complete the assessments</measure>
    <time_frame>1 year</time_frame>
    <description>treatment tolerability (rate of CBT-I and acupuncture completion, defined as completing at least 4 out of 7 sessions of CBT-I and 8 out of 10 sessions of acupuncture)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Insomnia</condition>
  <condition>Related Distress Among Cancer Caregivers</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy for Insomnia (CBT-I)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Session 1- Review of initial sleep diary, formulation of impression of type/subtype of insomnia, determine modifiable factors, address immediate concerns about participation, discuss motivation &amp; compliance. Session 2- Review of sleep diary, present 4-P model of insomnia, prescribe Sleep Restriction &amp; Stimulus Control Therapy. Session 3- Review of sleep diary, continue with stimulus control &amp; sleep restriction procedures, review of sleep hygiene. Session 4- Review of sleep diary, continue with stimulus control &amp; sleep restriction procedures, introduce &amp; practice relaxation strategies. Session 5- Review of sleep diary, continue with stimulus control &amp; sleep restriction procedures, conduct cognitive therapy to address dysfunctional thoughts underlying insomnia. Session 6- Review of sleep diary, continue with stimulus control &amp; sleep restriction procedures Session 7- Review of sleep diary &amp; overall progress, discuss relapse prevention, further sleep restriction guidelines &amp; prophylaxis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Session 1 - Detailed history and examination, introduction to acupuncture. Sessions 2 - 10 - Each session will begin with insertion and manipulation of needles, which will remain in place for 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia (CBT-I)</intervention_name>
    <arm_group_label>Cognitive Behavioral Therapy for Insomnia (CBT-I)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <arm_group_label>Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>questionnaires</intervention_name>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_label>Cognitive Behavioral Therapy for Insomnia (CBT-I)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diurnal Cortisol</intervention_name>
    <description>saliva test</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_label>Cognitive Behavioral Therapy for Insomnia (CBT-I)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  As per self report, age 18 and older&#xD;
&#xD;
          -  As per self report, identifying as an informal caregiver to MSKCC patients of any site&#xD;
             or stage of cancer&#xD;
&#xD;
          -  Score greater than 7 on the Insomnia Severity Index and meet the criteria for Insomnia&#xD;
             Disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th&#xD;
             Edition (DSM-5) (56) as assessed by the Insomnia Interview Schedule&#xD;
&#xD;
          -  In the judgment of the investigators and/or consenting professional, able to read and&#xD;
             comprehend English&#xD;
&#xD;
          -  In the judgment of the consenting professional cognitively able to provide informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  As per self report, participant has another sleep disorder provided that it is not&#xD;
             adequately treated (e.g., sleep apnea without CPAP treatment)&#xD;
&#xD;
          -  As per self report, participant has major depressive disorder, alcohol or drug&#xD;
             dependence and&#xD;
&#xD;
          -  As per self report, heavy drinker (regularly having more than 14 alcoholic beverages&#xD;
             per week)&#xD;
&#xD;
          -  As per self report, engaging in night shift work&#xD;
&#xD;
          -  To not obscure cortisol assessment, regular smokers per self report (daily use) will&#xD;
             be excluded.&#xD;
&#xD;
          -  As per self report significant needle phobia as to prevent participation in&#xD;
             acupuncture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allison Applebaum, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunter College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>17-001</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03012425
org study id: 17-001
nct id: NCT03012425
lead sponsor: 
collaborator: 
The other aim of this study is to determine which of those two treatments (acupuncture or
      cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of
      cancer patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of participants who complete the assessments
time frame: 1 year
description: treatment tolerability (rate of CBT-I and acupuncture completion, defined as completing at least 4 out of 7 sessions of CBT-I and 8 out of 10 sessions of acupuncture)
arm group label: Cognitive Behavioral Therapy for Insomnia (CBT-I)
arm group type: Experimental
description: Session 1- Review of initial sleep diary, formulation of impression of type/subtype of insomnia, determine modifiable factors, address immediate concerns about participation, discuss motivation & compliance. Session 2- Review of sleep diary, present 4-P model of insomnia, prescribe Sleep Restriction & Stimulus Control Therapy. Session 3- Review of sleep diary, continue with stimulus control & sleep restriction procedures, review of sleep hygiene. Session 4- Review of sleep diary, continue with stimulus control & sleep restriction procedures, introduce & practice relaxation strategies. Session 5- Review of sleep diary, continue with stimulus control & sleep restriction procedures, conduct cognitive therapy to address dysfunctional thoughts underlying insomnia. Session 6- Review of sleep diary, continue with stimulus control & sleep restriction procedures Session 7- Review of sleep diary & overall progress, discuss relapse prevention, further sleep restriction guidelines & prophylaxis.
arm group label: Acupuncture
arm group type: Experimental
description: Session 1 - Detailed history and examination, introduction to acupuncture. Sessions 2 - 10 - Each session will begin with insertion and manipulation of needles, which will remain in place for 30 minutes.
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia (CBT-I)
arm group label: Cognitive Behavioral Therapy for Insomnia (CBT-I)
intervention type: Procedure
intervention name: Acupuncture
arm group label: Acupuncture
intervention type: Behavioral
intervention name: questionnaires
arm group label: Acupuncture
arm group label: Cognitive Behavioral Therapy for Insomnia (CBT-I)
intervention type: Other
intervention name: Diurnal Cortisol
description: saliva test
arm group label: Acupuncture
arm group label: Cognitive Behavioral Therapy for Insomnia (CBT-I)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Allison Applebaum, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Hydrocortisone