<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/NCT02984670</url>
  </required_header>
  <id_info>
    <org_study_id>CBT-I CMM</org_study_id>
    <nct_id>NCT02984670</nct_id>
  </id_info>
  <brief_title>Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators</brief_title>
  <official_title>Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stockholm University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stockholm University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose with this investigation is to further our knowledge about cognitive&#xD;
      behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and&#xD;
      moderators. The first aim that will be addressed is to explore the efficacy of the CBT&#xD;
      components with a dismantling-treatment strategy. Two active CBT interventions, intended to&#xD;
      define its components - cognitive therapy and behavior therapy - will be compared with one&#xD;
      another as well as with a waitlist condition on a broad range of outcomes at five to nine&#xD;
      assessment points depending on the measures. The design will thus enable us to examine what&#xD;
      CBT component or components are necessary, sufficient and facilitative of therapeutic change.&#xD;
      The second aim that will be explored is to investigate what processes occur in CBT that may&#xD;
      contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for&#xD;
      CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep&#xD;
      Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep&#xD;
      Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed,&#xD;
      napping, bedtime variability, and rise time variability. The hypothesis is that cognitive&#xD;
      processes will mediate cognitive therapy outcomes, and that behavioral factors will have a&#xD;
      mediating role for behavior therapy improvements. The third aim that will be addressed is to&#xD;
      examine what patient characteristics does CBT depend on to be effective with a&#xD;
      treatment-moderator strategy. To investigate moderators for CBT, the following moderators&#xD;
      will be assessed; age, gender, occupational status, level of education, initial insomnia&#xD;
      severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical&#xD;
      co-morbidity, behavioral and cognitive processes used as mediators will also be employed as&#xD;
      moderators.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Changes on the insomnia severity index (ISI).</measure>
    <time_frame>Pretreatment (week 0), during treatment (i.e., at week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes on the Work and Social Adjustment Scale (WSAS).</measure>
    <time_frame>Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sleep onset latency (SOL).</measure>
    <time_frame>Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in wake time after sleep onset (WASO).</measure>
    <time_frame>Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in early morning awakenings (EMA).</measure>
    <time_frame>Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total sleep time (TST).</measure>
    <time_frame>Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in nighttime symptoms, by using item 1 - 3 from the primary outcome measure.</measure>
    <time_frame>Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in impairment, by using item 5 and 6 from the primary outcome measure.</measure>
    <time_frame>Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in distress, by using item 4 and 7 from the primary outcome measure.</measure>
    <time_frame>Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Brunnsviken Brief Quality of life index (BBQ)</measure>
    <time_frame>Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Credibility Expectancy Questionnaire (CEQ ).</measure>
    <time_frame>During the first treatment module.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-8).</measure>
    <time_frame>Post-treatment (week 10).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Activity and adherence with treatment protocol (self developed questionnaire assessing treatment activity and adherence relating to text, homework and therapist support).</measure>
    <time_frame>Post-treatment (week 10).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Sick-leave and other concomitant treatment (self developed questionnaire).</measure>
    <time_frame>Post-treatment (week 10).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events (questionnaire from a previous similar study).</measure>
    <time_frame>Post-treatment (week 10).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in physical activity (self developed questionnaire).</measure>
    <time_frame>Pretreatment (week 0) and post-treatment (week 10).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Ford Insomnia Response To Stress Test (FIRST).</measure>
    <time_frame>Pretreatment (week 0) and post-treatment (week 10) for the waitlist.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Daytime Insomnia Symptom Response Scale (DISRS)</measure>
    <time_frame>Pretreatment (week 0) and post-treatment (week 10) for the waitlist.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Montgomery Åsberg Depression Rating Scale (MADRS).</measure>
    <time_frame>Pretreatment (week 0).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in suicide risk (Item 9 from the MADRS).</measure>
    <time_frame>Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <arm_group>
    <arm_group_label>Behavior Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Therapy</intervention_name>
    <description>Cognitive Therapy involves challenging negative automatic thoughts about sleep and the use of behavioral experiments to challenge and test five cognitive processes (i.e., worry, dysfunctional thoughts, monitoring, safety behaviours, misperception) proposed to perpetuate insomnia.</description>
    <arm_group_label>Cognitive Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavior Therapy</intervention_name>
    <description>Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles.</description>
    <arm_group_label>Behavior Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Waitlist.</intervention_name>
    <description>The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups.</description>
    <arm_group_label>Waitlist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of insomnia more than three nights per week and for more than three months.&#xD;
&#xD;
          -  Insomnia despite adequate opportunity to sleep.&#xD;
&#xD;
          -  Insomnia severity typical for insomnia disorder, i.e. 11 points or more on the&#xD;
             Insomnia Severity Index (ISI).&#xD;
&#xD;
          -  Nighttime insomnia symptoms, i.e., two points or more on at least one of the first&#xD;
             three ISI questions.&#xD;
&#xD;
          -  Daytime insomnia symptoms, i.e. two points or more on one or both of the ISI distress&#xD;
             and impairment items (numbers 5 and 7).&#xD;
&#xD;
          -  Clinical insomnia symptoms from sleep diaries concerning three nighttime symptoms&#xD;
             (difficulties with sleep initiation, difficulties with sleep maintenance, and early&#xD;
             morning awakenings), i.e., thirty minutes or more on average on one or more of the&#xD;
             symptoms.&#xD;
&#xD;
          -  No current or past CBT-I treatment within the past 5 years.&#xD;
&#xD;
          -  Time and opportunity to participate in treatment for ten weeks.&#xD;
&#xD;
          -  Time and opportunity to read approximately fifteen pages per week and execute homework&#xD;
             assignments for ten weeks.&#xD;
&#xD;
          -  Access to a computer, email and internet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe depression, i.e., more than 30 points on MADRS-S.&#xD;
&#xD;
          -  Suicidal risk, i.e., 4 points or more on item 9 on MADRS-S.&#xD;
&#xD;
          -  A high intake of alcohol or caffeine,&#xD;
&#xD;
          -  Insomnia due to shiftwork or other sleep-disturbing events (e.g., pregnancy, small&#xD;
             children, or animals in the sleep environment).&#xD;
&#xD;
          -  Participants with a history of psychotic or bipolar disorder.&#xD;
&#xD;
          -  If a somatic condition is reported, it is required that it is relatively stable and/or&#xD;
             that the candidate is receiving treatment for the condition.&#xD;
&#xD;
          -  When a candidate fulfills criteria for a psychiatric or somatic condition, it is&#xD;
             required that insomnia is the disorder currently most distressing and disabling or&#xD;
             that the insomnia remains despite treatment for the comorbid condition.&#xD;
&#xD;
          -  Participants with the following primary sleep disorders will be excluded via the Duke&#xD;
             Structured Interview for Sleep Disorders (DSISD): sleep apnea, restless legs syndrome,&#xD;
             periodic limb movement disorder, circadian rhythm disorder, and parasomnias.&#xD;
&#xD;
          -  If sleep medication is used, it is required that the use has been relatively stable&#xD;
             during three months.&#xD;
&#xD;
          -  If Selective Serotonin Reuptake Inhibitors (SSRI) use is reported, it is required that&#xD;
             the onset of the medication was at least three months prior to the telephone&#xD;
             interview.&#xD;
&#xD;
          -  Participants who regularly consume sleep-disturbing medications.&#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>Markus Jansson Fröjmark, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stockholm University</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/24865869</url>
    <description>Comparative Efficacy of Behavior Therapy, Cognitive Therapy, and Cognitive Behavior Therapy for Chronic Insomnia: A Randomized Controlled Trial</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stockholm University</investigator_affiliation>
    <investigator_full_name>Markus Jansson-Fröjmark</investigator_full_name>
    <investigator_title>PhD.</investigator_title>
  </responsible_party>
  <keyword>Cognitive therapy</keyword>
  <keyword>Behavior therapy</keyword>
  <keyword>Moderation</keyword>
  <keyword>Mediation</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02984670
org study id: CBT-I CMM
nct id: NCT02984670
lead sponsor: 
has dmc: No
The overall purpose with this investigation is to further our knowledge about cognitive
      behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and
      moderators. The first aim that will be addressed is to explore the efficacy of the CBT
      components with a dismantling-treatment strategy. Two active CBT interventions, intended to
      define its components - cognitive therapy and behavior therapy - will be compared with one
      another as well as with a waitlist condition on a broad range of outcomes at five to nine
      assessment points depending on the measures. The design will thus enable us to examine what
      CBT component or components are necessary, sufficient and facilitative of therapeutic change.
      The second aim that will be explored is to investigate what processes occur in CBT that may
      contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for
      CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep
      Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep
      Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed,
      napping, bedtime variability, and rise time variability. The hypothesis is that cognitive
      processes will mediate cognitive therapy outcomes, and that behavioral factors will have a
      mediating role for behavior therapy improvements. The third aim that will be addressed is to
      examine what patient characteristics does CBT depend on to be effective with a
      treatment-moderator strategy. To investigate moderators for CBT, the following moderators
      will be assessed; age, gender, occupational status, level of education, initial insomnia
      severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical
      co-morbidity, behavioral and cognitive processes used as mediators will also be employed as
      moderators.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes on the insomnia severity index (ISI).
time frame: Pretreatment (week 0), during treatment (i.e., at week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
measure: Changes on the Work and Social Adjustment Scale (WSAS).
time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
measure: Changes in sleep onset latency (SOL).
time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
measure: Changes in wake time after sleep onset (WASO).
time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
measure: Changes in early morning awakenings (EMA).
time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
measure: Changes in total sleep time (TST).
time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
measure: Changes in Hospital Anxiety and Depression Scale (HADS)
time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
measure: Changes in nighttime symptoms, by using item 1 - 3 from the primary outcome measure.
time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
measure: Changes in impairment, by using item 5 and 6 from the primary outcome measure.
time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
measure: Changes in distress, by using item 4 and 7 from the primary outcome measure.
time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
measure: Changes in Brunnsviken Brief Quality of life index (BBQ)
time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
measure: Credibility Expectancy Questionnaire (CEQ ).
time frame: During the first treatment module.
measure: Client Satisfaction Questionnaire (CSQ-8).
time frame: Post-treatment (week 10).
measure: Activity and adherence with treatment protocol (self developed questionnaire assessing treatment activity and adherence relating to text, homework and therapist support).
time frame: Post-treatment (week 10).
measure: Sick-leave and other concomitant treatment (self developed questionnaire).
time frame: Post-treatment (week 10).
measure: Adverse events (questionnaire from a previous similar study).
time frame: Post-treatment (week 10).
measure: Changes in physical activity (self developed questionnaire).
time frame: Pretreatment (week 0) and post-treatment (week 10).
measure: Changes in Ford Insomnia Response To Stress Test (FIRST).
time frame: Pretreatment (week 0) and post-treatment (week 10) for the waitlist.
measure: Changes in Daytime Insomnia Symptom Response Scale (DISRS)
time frame: Pretreatment (week 0) and post-treatment (week 10) for the waitlist.
measure: Montgomery Åsberg Depression Rating Scale (MADRS).
time frame: Pretreatment (week 0).
measure: Changes in suicide risk (Item 9 from the MADRS).
time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
arm group label: Behavior Therapy
arm group type: Experimental
arm group label: Cognitive Therapy
arm group type: Experimental
arm group label: Waitlist
arm group type: Other
intervention type: Behavioral
intervention name: Cognitive Therapy
description: Cognitive Therapy involves challenging negative automatic thoughts about sleep and the use of behavioral experiments to challenge and test five cognitive processes (i.e., worry, dysfunctional thoughts, monitoring, safety behaviours, misperception) proposed to perpetuate insomnia.
arm group label: Cognitive Therapy
intervention type: Behavioral
intervention name: Behavior Therapy
description: Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles.
arm group label: Behavior Therapy
intervention type: Behavioral
intervention name: Waitlist.
description: The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups.
arm group label: Waitlist
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Markus Jansson Fröjmark, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
url: https://www.ncbi.nlm.nih.gov/pubmed/24865869
description: Comparative Efficacy of Behavior Therapy, Cognitive Therapy, and Cognitive Behavior Therapy for Chronic Insomnia: A Randomized Controlled Trial
responsible party type: Principal Investigator
investigator affiliation: Stockholm University
investigator full name: Markus Jansson-Fröjmark
investigator title: PhD.
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No