<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/NCT04402619</url>
  </required_header>
  <id_info>
    <org_study_id>BCS Sömnskola</org_study_id>
    <nct_id>NCT04402619</nct_id>
  </id_info>
  <brief_title>Online Cognitive Behavior Therapy for Comorbid Sleep Problems in Alcohol Use Disorder</brief_title>
  <official_title>Online Cognitive Behavior Therapy in Routine Addiction Care for Comorbid Sleep Problems in Alcohol Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      The main goal is to study the effects of internet-delivered cognitive behavioural therapy&#xD;
      with minimum guidance for comorbid sleep problems in alcohol use disorder, in routine&#xD;
      addiction care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol use disorder (AUD) is highly prevalent and a major contributor to the global burden&#xD;
      of disease. Insomnia symptoms are very common among individuals with AUD, including those in&#xD;
      recovery, which may in turn promote alcohol relapse. Specialization and silo phenomena in&#xD;
      healthcare organization, separating addiction from other types of psychiatric care, means&#xD;
      that individuals with AUD and comorbid sleep problems often have difficulty accessing&#xD;
      evidence-treatment for the latter. Offering online treatment for sleep problems to&#xD;
      individuals enrolled in traditional routine addiction care is an attractive and pragmatic&#xD;
      approach to offering parallel treatments covering the full clinical presentation, which has&#xD;
      not yet been evaluated. This pilot and feasibility trial will recruit n=25 from patients in&#xD;
      routine addiction care with comorbid sleep problems and AUD, who will complete an online,&#xD;
      ten-module, CBT-based treatment program with minimum guidance for sleep problems, tailored&#xD;
      for individuals with AUD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 13, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Two-item Sleep Condition Indicator</measure>
    <time_frame>Weeks 1 through 10 (max 15)</time_frame>
    <description>Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Condition Indicator</measure>
    <time_frame>Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..</time_frame>
    <description>Change in score on the full and regular SCI. Administered through the online survey tool connected to regular patient records system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily sleep diary</measure>
    <time_frame>Weeks 1 through 10 (max 15)</time_frame>
    <description>Derived measures: last-week average sleep efficiency, time to fall asleep, time awake at night, total sleep time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily alcohol diary</measure>
    <time_frame>Weeks 1 through 10 (max 15)</time_frame>
    <description>Total consumed standard units of alcohol per week, during day and before bedtime</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use Disorders Identification Test (AUDIT)</measure>
    <time_frame>Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..</time_frame>
    <description>Total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Use Disorders Identification Test (DUDIT)</measure>
    <time_frame>Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..</time_frame>
    <description>Total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ9)</measure>
    <time_frame>Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..</time_frame>
    <description>Total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life (EQ5D)</measure>
    <time_frame>Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..</time_frame>
    <description>Total score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Insomnia</condition>
  <condition>Sleep Disorder</condition>
  <condition>Dyssomnias</condition>
  <arm_group>
    <arm_group_label>Online CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ten modules with minimum therapist guidance</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavior therapy</intervention_name>
    <description>The ten modules cover:&#xD;
Psychoeducation about sleep, sleep problems, and associations with alcohol&#xD;
How to keep and use a sleep diary&#xD;
Sleep hygiene&#xD;
Sleep compression&#xD;
Cognitive restructuring&#xD;
Emotional regulation&#xD;
Preparing for the future</description>
    <arm_group_label>Online CBT</arm_group_label>
    <other_name>Sleep compression</other_name>
    <other_name>Sleep hygiene</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled patient at Stockholm Center for Dependency Disorders&#xD;
&#xD;
          -  Diagnosed alcohol use disorder&#xD;
&#xD;
          -  Self-rated sleep problem&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Addiction to sedative or hypnotic medication&#xD;
&#xD;
          -  Psychoactive medication not yet 3-month stable in dose&#xD;
&#xD;
          -  Bipolar disorder&#xD;
&#xD;
          -  Psychotic disorder&#xD;
&#xD;
          -  Suicidality&#xD;
&#xD;
          -  Periodic Limb Movement Disorder (PLMD)&#xD;
&#xD;
          -  Sleep apnea&#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>Philip Lindner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philip Lindner, PhD</last_name>
    <phone>+46704522587</phone>
    <email>philip.lindner@ki.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm)</name>
      <address>
        <city>Stockholm</city>
        <zip>18354</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Philip Lindner, PhD</last_name>
      <phone>+46704522587</phone>
      <email>philip.lindner@ki.se</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stockholm Centre for Dependency Disorders</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miriam Jakobson</last_name>
      <email>miriam.jakobson@sll.se</email>
    </contact>
    <investigator>
      <last_name>Philip Lindner, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Kaldo V, Jernelov S, Blom K, Ljotsson B, Brodin M, Jorgensen M, Kraepelien M, Ruck C, Lindefors N. Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial. Behav Res Ther. 2015 Aug;71:90-100. doi: 10.1016/j.brat.2015.06.001. Epub 2015 Jun 3.</citation>
    <PMID>26091917</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>August 26, 2022</last_update_submitted>
  <last_update_submitted_qc>August 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Philip Lindner</investigator_full_name>
    <investigator_title>Head of Research and Development, Maria Ungdom Clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Raw outcomes, with any other identifiable information, may be shared under the conditions described below.</ipd_description>
    <ipd_time_frame>Requests for data will be accepted upon publication of trial, and for ten years after.</ipd_time_frame>
    <ipd_access_criteria>Signed data sharing agreement.</ipd_access_criteria>
  </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/NCT04402619
org study id: BCS Sömnskola
nct id: NCT04402619
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main goal is to study the effects of internet-delivered cognitive behavioural therapy
      with minimum guidance for comorbid sleep problems in alcohol use disorder, in routine
      addiction care.
Alcohol use disorder (AUD) is highly prevalent and a major contributor to the global burden
      of disease. Insomnia symptoms are very common among individuals with AUD, including those in
      recovery, which may in turn promote alcohol relapse. Specialization and silo phenomena in
      healthcare organization, separating addiction from other types of psychiatric care, means
      that individuals with AUD and comorbid sleep problems often have difficulty accessing
      evidence-treatment for the latter. Offering online treatment for sleep problems to
      individuals enrolled in traditional routine addiction care is an attractive and pragmatic
      approach to offering parallel treatments covering the full clinical presentation, which has
      not yet been evaluated. This pilot and feasibility trial will recruit n=25 from patients in
      routine addiction care with comorbid sleep problems and AUD, who will complete an online,
      ten-module, CBT-based treatment program with minimum guidance for sleep problems, tailored
      for individuals with AUD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Two-item Sleep Condition Indicator
time frame: Weeks 1 through 10 (max 15)
description: Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.
measure: Sleep Condition Indicator
time frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
description: Change in score on the full and regular SCI. Administered through the online survey tool connected to regular patient records system.
measure: Daily sleep diary
time frame: Weeks 1 through 10 (max 15)
description: Derived measures: last-week average sleep efficiency, time to fall asleep, time awake at night, total sleep time.
measure: Daily alcohol diary
time frame: Weeks 1 through 10 (max 15)
description: Total consumed standard units of alcohol per week, during day and before bedtime
measure: Alcohol Use Disorders Identification Test (AUDIT)
time frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
description: Total score
measure: Drug Use Disorders Identification Test (DUDIT)
time frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
description: Total score
measure: Patient Health Questionnaire-9 (PHQ9)
time frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
description: Total score
measure: Health-related quality of life (EQ5D)
time frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
description: Total score
arm group label: Online CBT
arm group type: Experimental
description: Ten modules with minimum therapist guidance
intervention type: Behavioral
intervention name: Cognitive behavior therapy
description: The ten modules cover:
Psychoeducation about sleep, sleep problems, and associations with alcohol
How to keep and use a sleep diary
Sleep hygiene
Sleep compression
Cognitive restructuring
Emotional regulation
Preparing for the future
arm group label: Online CBT
other name: Sleep compression
other name: Sleep hygiene
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philip Lindner, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Philip Lindner, PhD
phone: +46704522587
email: philip.lindner@ki.se
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Sweden
citation: Kaldo V, Jernelov S, Blom K, Ljotsson B, Brodin M, Jorgensen M, Kraepelien M, Ruck C, Lindefors N. Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial. Behav Res Ther. 2015 Aug;71:90-100. doi: 10.1016/j.brat.2015.06.001. Epub 2015 Jun 3.
PMID: 26091917
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Philip Lindner
investigator title: Head of Research and Development, Maria Ungdom Clinic
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Dyssomnias
mesh term: Alcoholism
mesh term: Alcohol Drinking
sharing ipd: Yes
ipd description: Raw outcomes, with any other identifiable information, may be shared under the conditions described below.
ipd time frame: Requests for data will be accepted upon publication of trial, and for ten years after.
ipd access criteria: Signed data sharing agreement.