<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/NCT03783585</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00142464</org_study_id>
    <nct_id>NCT03783585</nct_id>
  </id_info>
  <brief_title>Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis</brief_title>
  <official_title>Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Forty individuals with multiple sclerosis (MS) will be randomly assigned to a 6-week&#xD;
      web-based cognitive behavior therapy for insomnia intervention (wCBT-I) or to wCBT-I plus&#xD;
      biweekly support meetings with research personnel via phone or video. Questionnaires will be&#xD;
      used to assess sleep quality, fatigue, and satisfaction. Recruitment, retention, attrition,&#xD;
      adherence, and safety information will also be collected. This study is significant because&#xD;
      addressing insomnia symptoms through CBT-I could be a low-cost, low-risk, non-pharmacological&#xD;
      options for improving sleep quality and MS symptoms in individuals with MS. This study is&#xD;
      innovative because CBT-I has never been delivered via a web-based application to individuals&#xD;
      with MS which may increase access to services.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">August 20, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Insomnia Severity Index (ISI)</measure>
    <time_frame>baseline and week 8</time_frame>
    <description>The ISI is a valid and reliable measure of sleep difficulties and consists of 7 questions each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with ≥10 suggesting clinical insomnia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>baseline and week 8</time_frame>
    <description>The PSQI is a well-validated and reliable measure of sleep quality and consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of &gt;5 reflects poor sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Modified Fatigue Impact Scale (MFIS)</measure>
    <time_frame>baseline and week 8</time_frame>
    <description>The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Fatigue Severity Scale (FSS)</measure>
    <time_frame>baseline and week 8</time_frame>
    <description>Fatigue Severity Scale (FSS) assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Multiple Sclerosis Impact Scale (MSIS)</measure>
    <time_frame>baseline and week 8</time_frame>
    <description>MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>cognitive behavioral therapy for insomnia (CBT-I)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will participate in a 6-week web-based cognitive behavioral therapy for insomnia (CBT-I) program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBT-I + biweekly support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will participate in a 6-week web-based CBT-I program. In addition, biweekly support consisting of one-on-one, semi-structured, online video-chat sessions (via HIPAA-compliant Zoom) or phone calls will be conducted every other week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy for insomnia</intervention_name>
    <description>The web-based CBT-I program is a 6-week interactive, online program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, and cognitive restructuring.</description>
    <arm_group_label>CBT-I + biweekly support</arm_group_label>
    <arm_group_label>cognitive behavioral therapy for insomnia (CBT-I)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy for insomnia + biweekly support</intervention_name>
    <description>Individuals randomized into the CBT-I + biweekly support will participate in CBT-I as described as well as a biweekly phone call or video call with research personnel for motivational interviewing.</description>
    <arm_group_label>CBT-I + biweekly support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 years old&#xD;
&#xD;
          -  diagnosis of MS by physician&#xD;
&#xD;
          -  report of difficulty falling asleep, maintaining sleep, or waking up too early at&#xD;
             least 3 nights/week for the past 6 months&#xD;
&#xD;
          -  ≥10 on Insomnia Severity Index (ISI)&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  reports access to internet service and phone&#xD;
&#xD;
          -  has a high school diploma to serve as a proxy measurement of reading ability to ensure&#xD;
             adequate reading ability to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known untreated sleep disorder (such as sleep apnea or restless leg syndrome)&#xD;
&#xD;
          -  &gt;3 on STOP BANG indicating risk of sleep apnea&#xD;
&#xD;
          -  increased risk of restless leg syndrome&#xD;
&#xD;
          -  nervous system disorder other than MS&#xD;
&#xD;
          -  relapse and/or corticosteroid use in past 8 weeks&#xD;
&#xD;
          -  score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression&#xD;
             or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)&#xD;
&#xD;
          -  performs shift-work.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Siengsukon, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catherine Siengsukon</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>August 26, 2019</last_update_submitted>
  <last_update_submitted_qc>August 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Catherine Siengsukon, PT, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_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/NCT03783585
org study id: STUDY00142464
nct id: NCT03783585
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Forty individuals with multiple sclerosis (MS) will be randomly assigned to a 6-week
      web-based cognitive behavior therapy for insomnia intervention (wCBT-I) or to wCBT-I plus
      biweekly support meetings with research personnel via phone or video. Questionnaires will be
      used to assess sleep quality, fatigue, and satisfaction. Recruitment, retention, attrition,
      adherence, and safety information will also be collected. This study is significant because
      addressing insomnia symptoms through CBT-I could be a low-cost, low-risk, non-pharmacological
      options for improving sleep quality and MS symptoms in individuals with MS. This study is
      innovative because CBT-I has never been delivered via a web-based application to individuals
      with MS which may increase access to services.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change in Insomnia Severity Index (ISI)
time frame: baseline and week 8
description: The ISI is a valid and reliable measure of sleep difficulties and consists of 7 questions each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with ≥10 suggesting clinical insomnia
measure: change in Pittsburgh Sleep Quality Index (PSQI)
time frame: baseline and week 8
description: The PSQI is a well-validated and reliable measure of sleep quality and consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of >5 reflects poor sleep quality
measure: change in Modified Fatigue Impact Scale (MFIS)
time frame: baseline and week 8
description: The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.
measure: change in Fatigue Severity Scale (FSS)
time frame: baseline and week 8
description: Fatigue Severity Scale (FSS) assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.
measure: change in Multiple Sclerosis Impact Scale (MSIS)
time frame: baseline and week 8
description: MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS.
arm group label: cognitive behavioral therapy for insomnia (CBT-I)
arm group type: Experimental
description: Participants randomized to this arm will participate in a 6-week web-based cognitive behavioral therapy for insomnia (CBT-I) program.
arm group label: CBT-I + biweekly support
arm group type: Experimental
description: Participants randomized to this arm will participate in a 6-week web-based CBT-I program. In addition, biweekly support consisting of one-on-one, semi-structured, online video-chat sessions (via HIPAA-compliant Zoom) or phone calls will be conducted every other week.
intervention type: Behavioral
intervention name: Cognitive behavioral therapy for insomnia
description: The web-based CBT-I program is a 6-week interactive, online program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, and cognitive restructuring.
arm group label: CBT-I + biweekly support
arm group label: cognitive behavioral therapy for insomnia (CBT-I)
intervention type: Behavioral
intervention name: Cognitive behavioral therapy for insomnia + biweekly support
description: Individuals randomized into the CBT-I + biweekly support will participate in CBT-I as described as well as a biweekly phone call or video call with research personnel for motivational interviewing.
arm group label: CBT-I + biweekly support
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Catherine Siengsukon, PT, PhD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Catherine Siengsukon, PT, PhD
investigator title: Associate Professor
mesh term: Multiple Sclerosis
mesh term: Sclerosis