<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/NCT02261272</url>
  </required_header>
  <id_info>
    <org_study_id>SHUTiNorse</org_study_id>
    <nct_id>NCT02261272</nct_id>
  </id_info>
  <brief_title>Internet-based Treatment for Insomnia</brief_title>
  <acronym>SHUTiNorse</acronym>
  <official_title>Internet-based Treatment for Insomnia in Norway.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian Institute of Public Health</source>
  <brief_summary>
    <textblock>
      The study will test an internet-based treatment for insomnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will develop and evaluate the feasibility of a cost-effective, more accessible&#xD;
      alternative treatment approach for insomnia. Traditional CBT, including the behavioral,&#xD;
      cognitive, and educational aspects, will be operationalized and transformed for an Internet&#xD;
      intervention system, so individuals can access a personalized treatment any time, at their&#xD;
      own convenience. Phase 1 of this study will involve developing the web program. The&#xD;
      investigators research team and collaborators has extensive experience developing such web&#xD;
      interventions, as well as considerable experience with insomnia. Phase 2 will be a large&#xD;
      randomized controlled trial testing the Internet intervention compared to passive patient&#xD;
      education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post&#xD;
      the six week treatment program. It is hypothesized that the Internet intervention will&#xD;
      promote improvements in sleep, mood, and cognitive functioning. If successful, the current&#xD;
      project may result in improved implementation of a low-threshold treatment for a common&#xD;
      disorder with devastating impact on both individual and socioeconomic outcomes&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia symptoms</measure>
    <time_frame>Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU</time_frame>
    <description>Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daytime functioning (mental health problems and fatigue)</measure>
    <time_frame>Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU</time_frame>
    <description>Self-reported questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep diary data</measure>
    <time_frame>Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU</time_frame>
    <description>Sleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Psychophysiologic Insomnia</condition>
  <arm_group>
    <arm_group_label>CBT for insomnia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive-behavioral therapy for insomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Hygiene</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Psychoeducational intervention based on standard sleep hygiene advices</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT for insomnia SHUTi</intervention_name>
    <description>SHUTi</description>
    <arm_group_label>CBT for insomnia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>passive patient education/sleep hygiene</intervention_name>
    <arm_group_label>Sleep Hygiene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18 years or older&#xD;
&#xD;
          2. fulfillment of the DMS-IV criteria for insomnia&#xD;
&#xD;
          3. duration of at least 3 months&#xD;
&#xD;
          4. complaints of impaired daytime functioning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. presence of a major depressive disorder or other severe mental disorder as identified&#xD;
             by in the telephone interview&#xD;
&#xD;
          2. working night shifts and unable to discontinue this work pattern&#xD;
&#xD;
          3. having a serious somatic condition preventing further participation.&#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>
  <location>
    <facility>
      <name>Norwegian Institute of Public Health</name>
      <address>
        <city>Bergen</city>
        <zip>5000</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>November 1, 2013</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>September 20, 2016</last_update_submitted>
  <last_update_submitted_qc>September 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Norwegian Institute of Public Health</investigator_affiliation>
    <investigator_full_name>Borge Sivertsen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</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/NCT02261272
org study id: SHUTiNorse
nct id: NCT02261272
lead sponsor: 
The study will test an internet-based treatment for insomnia.
This study will develop and evaluate the feasibility of a cost-effective, more accessible
      alternative treatment approach for insomnia. Traditional CBT, including the behavioral,
      cognitive, and educational aspects, will be operationalized and transformed for an Internet
      intervention system, so individuals can access a personalized treatment any time, at their
      own convenience. Phase 1 of this study will involve developing the web program. The
      investigators research team and collaborators has extensive experience developing such web
      interventions, as well as considerable experience with insomnia. Phase 2 will be a large
      randomized controlled trial testing the Internet intervention compared to passive patient
      education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post
      the six week treatment program. It is hypothesized that the Internet intervention will
      promote improvements in sleep, mood, and cognitive functioning. If successful, the current
      project may result in improved implementation of a low-threshold treatment for a common
      disorder with devastating impact on both individual and socioeconomic outcomes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Insomnia symptoms
time frame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
description: Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU
measure: Daytime functioning (mental health problems and fatigue)
time frame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
description: Self-reported questionnaires
measure: Sleep diary data
time frame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
description: Sleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU
arm group label: CBT for insomnia
arm group type: Experimental
description: Cognitive-behavioral therapy for insomnia
arm group label: Sleep Hygiene
arm group type: Active Comparator
description: Psychoeducational intervention based on standard sleep hygiene advices
intervention type: Behavioral
intervention name: CBT for insomnia SHUTi
description: SHUTi
arm group label: CBT for insomnia
intervention type: Behavioral
intervention name: passive patient education/sleep hygiene
arm group label: Sleep Hygiene
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Norwegian Institute of Public Health
investigator full name: Borge Sivertsen
investigator title: Professor
mesh term: Sleep Initiation and Maintenance Disorders