<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/NCT01663844</url>
  </required_header>
  <id_info>
    <org_study_id>2012/934-31/4</org_study_id>
    <nct_id>NCT01663844</nct_id>
  </id_info>
  <brief_title>New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression</brief_title>
  <official_title>New Clinical Applications for Internet-based Cognitive Behavior Therapy: An Adaptive Treatment Strategy to Decrease the Number of Failed Treatments, and a Combination Treatment for Insomnia and Depression.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study includes two sub-trials. Both are included in this singe registration since they&#xD;
      have parallel inclusion of participants and have been approved by the Swedish ethics board&#xD;
      together in one application.&#xD;
&#xD;
      Trial 1 includes patients with both insomnia and major or minor depression. Participants are&#xD;
      randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or&#xD;
      to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The&#xD;
      primary purpose is to evaluate changes in insomnia and depression severity for the&#xD;
      combination treatment compared to the depression treatment, after treatment and at 6 and 36&#xD;
      months follow up. A secondary purpose is to evaluate cognitive functioning before and after&#xD;
      treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through&#xD;
      mass media and the Internet psychiatry clinic's regular patient recruitment.&#xD;
&#xD;
      Trial 2 includes patients with insomnia who do not meet criteria for major or minor&#xD;
      depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks&#xD;
      patients that are judged to be at risk of treatment failure are randomized to either&#xD;
      continued treatment or treatment with added support intended to enhance outcome. The primary&#xD;
      purpose is to evaluate change in insomnia severity for participants who get added support,&#xD;
      compared to continued treatment with regular support level. A secondary purpose is to&#xD;
      evaluate cognitive functioning before and after treatment, as well as cost effectiveness.&#xD;
      Recruitment is done in the Stockholm County through mass media and the Internet psychiatry&#xD;
      clinic's regular patient recruitment.&#xD;
&#xD;
      NOTE:&#xD;
&#xD;
      The first participants in trial 1 will be regarded as pilots, due to problems with the&#xD;
      experimental treatment: technical issues as well as problems with the design of treatment&#xD;
      modules. These problems were corrected when discovered. 12 participants in the experimental&#xD;
      arm were affected by these errors. The pilot participants will not be included in the main&#xD;
      analyses of data. This was decided upon on 31st of October 2014.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">May 2022</completion_date>
  <primary_completion_date type="Actual">December 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change (from baseline) in Insomnia Severity Index (ISI)</measure>
    <time_frame>0, 6 and 36 months after treatment</time_frame>
    <description>7-item, self-rated questionnaire measuring change in insomnia severity. Bastien, C. H., Vallières, A., &amp; Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S</measure>
    <time_frame>0, 6 and 36 months after treatment</time_frame>
    <description>Defined as secondary outcome measure in Trial 2. The use of two primary outcomes in trial 1 is motivated since participants have both diagnoses and the purpose is to look at effects on both insomnia and depression.&#xD;
The MADRS-S is a 9-item self-rated measure of change in depression severity. It also screens for suicidality.&#xD;
Mattila-Evenden, M., Svanborg, P., Gustavsson, P., &amp; Åsberg, M. (1996). Determinants of self-rating and expert rating concordance in psychiatric out-patients, using the affective subscales of CPRS. Acta Psychiatr Scand, 94, 386-396.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in Sleep Diary</measure>
    <time_frame>Directly after treatment</time_frame>
    <description>One week of self-ratings on a number of sleep parameters, resulting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjective sleep quality and daytime functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes (from baseline) in Actigraph data</measure>
    <time_frame>Directly post treatment</time_frame>
    <description>An actigraph is placed on the participant's arm for one week. They measure participants' activity in the form of movements. It will be used for acquiring sleep data and calculate sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings and daytime activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)</measure>
    <time_frame>0, 6 and 36 months after treatment</time_frame>
    <description>Health economic questionnaire evaluation cost for health care, absence of work capacity and related costs.&#xD;
Hakkaart-Van Roijen, L.,Van Straten, A., &amp; Donker, M. (2002). Manual: Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness. Rotterdam: Erasmus University</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in Cognitive functioning</measure>
    <time_frame>Directly at post-treatment</time_frame>
    <description>Computer based testing of executive functions, concentration, speed and memory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in EuroQuol. EQ-5D</measure>
    <time_frame>0, 6 and 36 months after treatment</time_frame>
    <description>General quality of life measure to complement the TIC-P in health economic analysis.&#xD;
Hinz, A., Klaiberg, A., Brahler, E., &amp; Konig, H.H. (2006). The Quality of Life Questionnaire EQ-5D: modelling and norm values for the general population. Psychother.Psychosom.Med.Psychol., 56, 42-48.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in Sheehan Disability Scale</measure>
    <time_frame>0, 6 and 36 months after treatment</time_frame>
    <description>Measures daily life functioning. Sheehan, D. V. (1983). The Anxiety disease. Scribner: New York</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM</measure>
    <time_frame>0, 6 and 36 months after treatment</time_frame>
    <description>Measures psychological health in general. Evans, C., Connell, J., Barkham, M., Margison, F., McGrath, G., Mellor-Clark, J. &amp; Audin, K. (2002). Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. The British journal of psychiatry : the journal of mental science 180, 51-60.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">440</enrollment>
  <condition>Insomnia</condition>
  <condition>Major Depression</condition>
  <condition>Minor Depression</condition>
  <arm_group>
    <arm_group_label>(Study 1) ICBT for insomnia and depression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>(Study 1) ICBT for depr. plus placebo insomnia intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>(Study 2) ICBT for insomnia with added support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>(Study 2) ICBT for insomnia with regular level of support</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapist guided Internet-CBT for insomnia w. extra support</intervention_name>
    <description>(Study 2) A 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia plus extra therapist support.</description>
    <arm_group_label>(Study 2) ICBT for insomnia with added support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapist guided Internet-CBT for insomnia</intervention_name>
    <description>(Study 2) A 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia. Regular therapist support.</description>
    <arm_group_label>(Study 2) ICBT for insomnia with regular level of support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapist guided Internet-CBT for insomnia and depression</intervention_name>
    <description>(Study 1) A 12 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia and depression.</description>
    <arm_group_label>(Study 1) ICBT for insomnia and depression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapist Guided Internet-CBT for depression plus insomnia placebo</intervention_name>
    <description>(Study 1) A 12 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. A placebo intervention for insomnia is added.</description>
    <arm_group_label>(Study 1) ICBT for depr. plus placebo insomnia intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical level of Insomnia (more than 10 on ISI)&#xD;
&#xD;
          -  Meets criteria for Insomnia according to DSM-IV-TR&#xD;
&#xD;
          -  Enough language skills&#xD;
&#xD;
          -  Only Trial 1: Meets criteria for Major or Minor Depressive Disorder according to&#xD;
             DSM-IV-TR (for minor depression a MADRS-S-level of &gt;19 is required).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sleep disorders requiring other treatment&#xD;
&#xD;
          -  Alcohol/drugs abuse&#xD;
&#xD;
          -  Started to use or changed the dose of antidepressant drug during the last 2 months&#xD;
&#xD;
          -  Somatic or psychiatric conditions requiring acute care&#xD;
&#xD;
          -  Working night shifts&#xD;
&#xD;
          -  Only Trial 2: Meets criteria for Major or Minor Depressive Disorder according to&#xD;
             DSM-IV-TR (for minor depression a MADRS-S-level of &gt;19 is required for exclusion).&#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>Viktor Kaldo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO</name>
      <address>
        <city>Stockholm</city>
        <zip>S-14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://www.internetpsykiatri.se</url>
    <description>The public page of the Internet Psychiatry Clinic</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>July 15, 2022</last_update_submitted>
  <last_update_submitted_qc>July 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Viktor Kaldo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cognitive behavior therapy</keyword>
  <keyword>Internet treatment</keyword>
  <keyword>Self-help treatment</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Depression</keyword>
  <keyword>ICBT</keyword>
  <keyword>CBT-i</keyword>
  <keyword>CBT-d</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>Depression</mesh_term>
    <mesh_term>Depressive 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/NCT01663844
org study id: 2012/934-31/4
nct id: NCT01663844
lead sponsor: 
collaborator: 
has dmc: No
This study includes two sub-trials. Both are included in this singe registration since they
      have parallel inclusion of participants and have been approved by the Swedish ethics board
      together in one application.

      Trial 1 includes patients with both insomnia and major or minor depression. Participants are
      randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or
      to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The
      primary purpose is to evaluate changes in insomnia and depression severity for the
      combination treatment compared to the depression treatment, after treatment and at 6 and 36
      months follow up. A secondary purpose is to evaluate cognitive functioning before and after
      treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through
      mass media and the Internet psychiatry clinic's regular patient recruitment.

      Trial 2 includes patients with insomnia who do not meet criteria for major or minor
      depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks
      patients that are judged to be at risk of treatment failure are randomized to either
      continued treatment or treatment with added support intended to enhance outcome. The primary
      purpose is to evaluate change in insomnia severity for participants who get added support,
      compared to continued treatment with regular support level. A secondary purpose is to
      evaluate cognitive functioning before and after treatment, as well as cost effectiveness.
      Recruitment is done in the Stockholm County through mass media and the Internet psychiatry
      clinic's regular patient recruitment.

      NOTE:

      The first participants in trial 1 will be regarded as pilots, due to problems with the
      experimental treatment: technical issues as well as problems with the design of treatment
      modules. These problems were corrected when discovered. 12 participants in the experimental
      arm were affected by these errors. The pilot participants will not be included in the main
      analyses of data. This was decided upon on 31st of October 2014.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change (from baseline) in Insomnia Severity Index (ISI)
time frame: 0, 6 and 36 months after treatment
description: 7-item, self-rated questionnaire measuring change in insomnia severity. Bastien, C. H., Vallières, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.
measure: Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
time frame: 0, 6 and 36 months after treatment
description: Defined as secondary outcome measure in Trial 2. The use of two primary outcomes in trial 1 is motivated since participants have both diagnoses and the purpose is to look at effects on both insomnia and depression.
The MADRS-S is a 9-item self-rated measure of change in depression severity. It also screens for suicidality.
Mattila-Evenden, M., Svanborg, P., Gustavsson, P., & Åsberg, M. (1996). Determinants of self-rating and expert rating concordance in psychiatric out-patients, using the affective subscales of CPRS. Acta Psychiatr Scand, 94, 386-396.
measure: Change (from baseline) in Sleep Diary
time frame: Directly after treatment
description: One week of self-ratings on a number of sleep parameters, resulting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjective sleep quality and daytime functioning.
measure: Changes (from baseline) in Actigraph data
time frame: Directly post treatment
description: An actigraph is placed on the participant's arm for one week. They measure participants' activity in the form of movements. It will be used for acquiring sleep data and calculate sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings and daytime activity.
measure: Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
time frame: 0, 6 and 36 months after treatment
description: Health economic questionnaire evaluation cost for health care, absence of work capacity and related costs.
Hakkaart-Van Roijen, L.,Van Straten, A., & Donker, M. (2002). Manual: Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness. Rotterdam: Erasmus University
measure: Change (from baseline) in Cognitive functioning
time frame: Directly at post-treatment
description: Computer based testing of executive functions, concentration, speed and memory.
measure: Change (from baseline) in EuroQuol. EQ-5D
time frame: 0, 6 and 36 months after treatment
description: General quality of life measure to complement the TIC-P in health economic analysis.
Hinz, A., Klaiberg, A., Brahler, E., & Konig, H.H. (2006). The Quality of Life Questionnaire EQ-5D: modelling and norm values for the general population. Psychother.Psychosom.Med.Psychol., 56, 42-48.
measure: Change (from baseline) in Sheehan Disability Scale
time frame: 0, 6 and 36 months after treatment
description: Measures daily life functioning. Sheehan, D. V. (1983). The Anxiety disease. Scribner: New York
measure: Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM
time frame: 0, 6 and 36 months after treatment
description: Measures psychological health in general. Evans, C., Connell, J., Barkham, M., Margison, F., McGrath, G., Mellor-Clark, J. & Audin, K. (2002). Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. The British journal of psychiatry : the journal of mental science 180, 51-60.
arm group label: (Study 1) ICBT for insomnia and depression
arm group type: Experimental
arm group label: (Study 1) ICBT for depr. plus placebo insomnia intervention
arm group type: Active Comparator
arm group label: (Study 2) ICBT for insomnia with added support
arm group type: Experimental
arm group label: (Study 2) ICBT for insomnia with regular level of support
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Therapist guided Internet-CBT for insomnia w. extra support
description: (Study 2) A 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia plus extra therapist support.
arm group label: (Study 2) ICBT for insomnia with added support
intervention type: Behavioral
intervention name: Therapist guided Internet-CBT for insomnia
description: (Study 2) A 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia. Regular therapist support.
arm group label: (Study 2) ICBT for insomnia with regular level of support
intervention type: Behavioral
intervention name: Therapist guided Internet-CBT for insomnia and depression
description: (Study 1) A 12 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia and depression.
arm group label: (Study 1) ICBT for insomnia and depression
intervention type: Behavioral
intervention name: Therapist Guided Internet-CBT for depression plus insomnia placebo
description: (Study 1) A 12 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. A placebo intervention for insomnia is added.
arm group label: (Study 1) ICBT for depr. plus placebo insomnia intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Viktor Kaldo, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
url: http://www.internetpsykiatri.se
description: The public page of the Internet Psychiatry Clinic
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Viktor Kaldo
investigator title: Principal Investigator
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression
mesh term: Depressive Disorder