<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/NCT01704352</url>
  </required_header>
  <id_info>
    <org_study_id>2012/1033</org_study_id>
    <nct_id>NCT01704352</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder</brief_title>
  <official_title>Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases.&#xD;
      Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive&#xD;
      behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not&#xD;
      been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral&#xD;
      therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators&#xD;
      hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor&#xD;
      mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and&#xD;
      insomnia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Change from baseline in quality of sleep at 8 weeks</measure>
    <time_frame>At 8 weeks from randomization</time_frame>
    <description>As assessed by the Insomnia Severity Index (ISI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in quality of sleep at 6 months follow-up</measure>
    <time_frame>6 months from end of treatment phase</time_frame>
    <description>As assessed by the Insomnia Severity Index (ISI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation in sleep registration from baseline to 8 weeks</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in sleep registration from baseline to 6 months follow-up</measure>
    <time_frame>At 6 months</time_frame>
    <description>Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Bipolar Disorder</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>CBT-I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive behavioral therapy for insomnia (CBT-I) is a multicomponent treatment consisting of sleep restriction therapy, psychoeducation about sleep, stimulus control, stabilizing circadian rhythm and challenging beliefs and perception of sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy for insomnia</intervention_name>
    <description>CBT-I will be given during 3-6 sessions according to need by two therapists being either psychiatrists or psychologists with clinical experience in CBT-I.</description>
    <arm_group_label>CBT-I</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfilling criteria for SCID-1-verified bipolar I or II disorder&#xD;
&#xD;
          -  Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher&#xD;
             than eleven, and Young Mania Rating scale (YMRS) not higher than five.&#xD;
&#xD;
          -  Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental&#xD;
             disorder, as assessed by the Insomnia Interview Schedule (IIS).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being or having been in a defined affective episode the last month before inclusion&#xD;
&#xD;
          -  Hospitalization in the last two months before inclusion&#xD;
&#xD;
          -  Working night shifts&#xD;
&#xD;
          -  Sleep apnea&#xD;
&#xD;
          -  Medical conditions incompatible with participation.&#xD;
&#xD;
          -  Inability to cooperate in the 3-week initial phase before randomization.&#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>Gunnar Morken, PhD Prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Østmarka Psychiatric Department, St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://www.ntnu.no/sleep-bp</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>CBT-I</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Bipolar Disorder</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/NCT01704352
org study id: 2012/1033
nct id: NCT01704352
lead sponsor: 
collaborator: 
has dmc: No
Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases.
      Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive
      behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not
      been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral
      therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators
      hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor
      mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and
      insomnia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in quality of sleep at 8 weeks
time frame: At 8 weeks from randomization
description: As assessed by the Insomnia Severity Index (ISI)
measure: Change from baseline in quality of sleep at 6 months follow-up
time frame: 6 months from end of treatment phase
description: As assessed by the Insomnia Severity Index (ISI)
measure: Variation in sleep registration from baseline to 8 weeks
time frame: At 8 weeks
description: Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
measure: Variation in sleep registration from baseline to 6 months follow-up
time frame: At 6 months
description: Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
arm group label: CBT-I
arm group type: Active Comparator
description: Cognitive behavioral therapy for insomnia (CBT-I) is a multicomponent treatment consisting of sleep restriction therapy, psychoeducation about sleep, stimulus control, stabilizing circadian rhythm and challenging beliefs and perception of sleep.
arm group label: Treatment as usual
arm group type: No Intervention
description: Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient.
intervention type: Behavioral
intervention name: Cognitive behavioral therapy for insomnia
description: CBT-I will be given during 3-6 sessions according to need by two therapists being either psychiatrists or psychologists with clinical experience in CBT-I.
arm group label: CBT-I
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gunnar Morken, PhD Prof
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
url: http://www.ntnu.no/sleep-bp
description: Related Info
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Bipolar Disorder