xml: <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/NCT06025968</url>
    </required_header>
    <id_info>
      <org_study_id>Uppsala univerisity</org_study_id>
      <nct_id>NCT06025968</nct_id>
    </id_info>
    <brief_title>Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis</brief_title>
    <official_title>Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis: A Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uppsala University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uppsala University</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 goal of this clinical trialis to compare a digital Cognitive-behavioral intervention for&#xD;
        insomnia to digital administered applied relaxation in participants with Multiple Sclerosis.&#xD;
  &#xD;
        The treatments will be compared in following outcomes:&#xD;
  &#xD;
          -  Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset&#xD;
             (WASO), and early morning awakening (EMA).&#xD;
  &#xD;
          -  Insomnia symptoms&#xD;
  &#xD;
          -  Depressive symptoms&#xD;
  &#xD;
          -  Client satisfaction&#xD;
  &#xD;
          -  Negative effects&#xD;
  &#xD;
          -  Worry&#xD;
  &#xD;
          -  Fatigue&#xD;
  &#xD;
          -  Quality of life&#xD;
  &#xD;
          -  MS symptoms/function&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In order to start evaluate the digital treatment format, this study will use a Randomized&#xD;
        Controlled Trial design (RCT). Participants with MS and insomnia from a Neurology clinic in&#xD;
        Sweden will be randomized to either Cognitive-behavioral intervention for insomnia (iCBT) or&#xD;
        Applied relaxation (AR). The treatments will consits of six sessions and will be administered&#xD;
        digitally. Psychologists will have contact with the participants via a secure video call&#xD;
        platform.Follow-up data will be gathered at six and 12 months after the treatments.&#xD;
  &#xD;
        The treatments will be compared in following outcomes:&#xD;
  &#xD;
          -  Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset&#xD;
             (WASO), and early morning awakening (EMA).&#xD;
  &#xD;
          -  Insomnia symptoms&#xD;
  &#xD;
          -  Depressive symptoms&#xD;
  &#xD;
          -  Worry&#xD;
  &#xD;
          -  Fatigue&#xD;
  &#xD;
          -  Quality of life&#xD;
  &#xD;
          -  MS symptoms/function&#xD;
  &#xD;
          -  Client satisfaction&#xD;
  &#xD;
          -  Negative effects&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>
      <intervention_model_description>Randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcomes will be adiministered via a digital platform.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Sleep diary - Total Wake Time (TWT)</measure>
      <time_frame>Baseline, daily through study completion, up to 8 weeks</time_frame>
      <description>Total wake time (TWT) is calculated by summing the variables Sleep onset latensy, Wake after slepp onset and Early morning awakening in minutes from the sleep diary. This measure has been used as an outcome measure in clinical studies of CBT-I because it may have better explanatory power than other variables in the sleep diary. .</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment, and 6 and 12 months after the treatment.</time_frame>
      <description>Measures the severity of insomnia and consists of seven questions regarding the individual's experience of insomnia with response options on a five-point Likert scale from 0-4. HIgher values indicating more severe insomna.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.s.</time_frame>
      <description>The PHQ-9 consists of nine questions designed according to diagnostic criteria for major depression in the DSM-5, as well as a question on level of functioning.Higher values indicating worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Generalized Anxiety Disorder (GAD-7)</measure>
      <time_frame>Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.</time_frame>
      <description>Questionnaire which is a seven-item, self-report anxiety questionnaire designed to assess feelings of anxiety and worrying (Spitzer 2006). Each item is scored on a Likert scale between 0 and 3 and totaled for a score of 0 to 21. Higher score indicating worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue Severity Scale (FSS)</measure>
      <time_frame>Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.</time_frame>
      <description>Consists of nine questions with response options on a seven-point Likert scale 1 - 7 (Krupp et al, 1989). The total score is divided by the number of questions to give a mean score between 1 - 7. The higher the score, the more severe the fatigue..</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Brunnsviken Brief Quality of Life Scale (BBQ)</measure>
      <time_frame>Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment, and 6 and 12 months after the treatment.</time_frame>
      <description>The BBQ comprise twelve items corresponding to satisfaction and importance of six life areas (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) and provides a total score between 0 and 96 with a higher score representing a higher level of quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative effects</measure>
      <time_frame>After the intervention.</time_frame>
      <description>Negative effects of the treatment were assessed with a questionnaire comprising 12 items regarding common symptoms such as fatigue, dizziness, and negative mood</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep diary- Sleep onset latensy (SOL)</measure>
      <time_frame>Baseline, daily through study completion, up to 8 weeks</time_frame>
      <description>It is measured in minutes and calculated. The participant will register this in the sleep diary.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep diary- wake after sleep onset (WASO)</measure>
      <time_frame>Baseline, daily through study completion, up to 8 weeks</time_frame>
      <description>It is measured in minutes and calculated. The participant will register this in the sleep diary.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep diary. early morning awakening (EMA)</measure>
      <time_frame>Baseline, daily through study completion, up to 8 weeks</time_frame>
      <description>It is measured in minutes and calculated. The participant will register this in the sleep diary.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Multiple Sclerosis Impact Scale (MSIS-29)</measure>
      <time_frame>Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.</time_frame>
      <description>The MSIS-29 measures physical and psychological impact of MS. Items on the MSIS-29 have a Likert scale format (range 1.00-5.00); higher scores indicate a greater degree of disability. Total score is derived by summing items and transforming them into a score out of 100; higher scores imply a greater degree of disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Satisfaction Questionnaire-8 (CSQ-8)</measure>
      <time_frame>After the treatment that is 6 to 8 weeks after entering the treatment</time_frame>
      <description>It is a brief global measure of client satisfaction..The CSQ-8 comprises eight items regarding service satisfaction that are scored on a 4-point Likert scale and provides a total score between 8 and 32. Higher values indicating higher satisfaction.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The severity of MS - MS check</measure>
      <time_frame>Screening</time_frame>
      <description>The MS check which is a self-assessment questionnaire consisting of 14 questions concerning fatigue, cognition, mood, vision, speech/communication, and other bodily functions scored on a scale from 0 to 3. Higher scores indicating more severe disability and symptoms related to MS.</description>
    </other_outcome>
    <other_outcome>
      <measure>The Credibility/Expectancy Questionnaire</measure>
      <time_frame>Will be administered after the first treament week.</time_frame>
      <description>The questionnaire contains 6 items rated on a 1-9 or a 0%-100% scale, depending upon the item. In the credibility factor the items explore: if the treatment appears logical; if the treatment appears useful; and if the treatment is reliable.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">69</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>i-CBT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cognitive behavioral therapy for insomnia with adjustment for MS.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Applied relaxation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Applied relaxation with adjustments for MS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>i-CBT</intervention_name>
      <description>The content is based on manual by Perlis et al (2015) and has slightly reworked by the research team by shortening treatment from seven to six sessions and allowing for day-time naps that may be necessary for patient with MS (Siengsukon et al. 2020). Due to the high prevalence of fatigue in people with MS, naps during the day may be a necessity to cope with everyday tasks. In cases where patients could not refrain from naps, they were advised to limit them to maximum 20 minutes and to take them as early in the day as possible. Other components are sleep restriction, sleep hygiene, stimulus control and cognitive techniques..</description>
      <arm_group_label>i-CBT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Applied relaxation</intervention_name>
      <description>Treatment consits of 6 modules. The main components in the training program will be progressive muscle relaxation, short relaxation with release only and without tension, and finally the participants will be taught rapid relaxation.</description>
      <arm_group_label>Applied relaxation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  be medically assessed&#xD;
  &#xD;
            -  meet criteria for MS and insomnia disorder&#xD;
  &#xD;
            -  have access to the internet and a smart phone with internet access&#xD;
  &#xD;
            -  have good reading ability, and&#xD;
  &#xD;
            -  be over 18 years of age&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  have a planned treatment that may prevent participation&#xD;
  &#xD;
            -  were involved in ongoing medical research that may prevent participation,&#xD;
  &#xD;
            -  do not have a command of the Swedish language&#xD;
  &#xD;
            -  have a more serious acute psychiatric and/or somatic condition which prevented&#xD;
               participation; or benefit from the treatment&#xD;
  &#xD;
            -  have an increased risk of suicide to the extent that participation in study was&#xD;
               considered inappropriate,&#xD;
  &#xD;
            -  suffers from other primary sleep disorders such as sleep apnea, restless legs&#xD;
               syndrome, periodic limb movement disorder, circadian rhythm disorder, or parasomnia&#xD;
  &#xD;
            -  have insomnia due to environmental factors such as shift work.&#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>Monica Buhrman, phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Uppsala University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Monica Buhrman, phd</last_name>
      <phone>+46733468539</phone>
      <email>Monica.Buhrman@psyk.uu.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Markus Jansson Fröjmark, phd</last_name>
      <email>markus.jansson-frojmark@ki.se</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Psychology, Uppsala University</name>
        <address>
          <city>Uppsala</city>
          <state>Uppland</state>
          <zip>75236</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uppsala University</investigator_affiliation>
      <investigator_full_name>Monica Buhrman</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025968
  org study id: Uppsala univerisity
  nct id: NCT06025968
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trialis to compare a digital Cognitive-behavioral intervention for
        insomnia to digital administered applied relaxation in participants with Multiple Sclerosis.
  
        The treatments will be compared in following outcomes:
  
          -  Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset
             (WASO), and early morning awakening (EMA).
  
          -  Insomnia symptoms
  
          -  Depressive symptoms
  
          -  Client satisfaction
  
          -  Negative effects
  
          -  Worry
  
          -  Fatigue
  
          -  Quality of life
  
          -  MS symptoms/function
  In order to start evaluate the digital treatment format, this study will use a Randomized
        Controlled Trial design (RCT). Participants with MS and insomnia from a Neurology clinic in
        Sweden will be randomized to either Cognitive-behavioral intervention for insomnia (iCBT) or
        Applied relaxation (AR). The treatments will consits of six sessions and will be administered
        digitally. Psychologists will have contact with the participants via a secure video call
        platform.Follow-up data will be gathered at six and 12 months after the treatments.
  
        The treatments will be compared in following outcomes:
  
          -  Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset
             (WASO), and early morning awakening (EMA).
  
          -  Insomnia symptoms
  
          -  Depressive symptoms
  
          -  Worry
  
          -  Fatigue
  
          -  Quality of life
  
          -  MS symptoms/function
  
          -  Client satisfaction
  
          -  Negative effects
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Outcomes will be adiministered via a digital platform.
  measure: Sleep diary - Total Wake Time (TWT)
  time frame: Baseline, daily through study completion, up to 8 weeks
  description: Total wake time (TWT) is calculated by summing the variables Sleep onset latensy, Wake after slepp onset and Early morning awakening in minutes from the sleep diary. This measure has been used as an outcome measure in clinical studies of CBT-I because it may have better explanatory power than other variables in the sleep diary. .
  measure: Insomnia Severity Index (ISI)
  time frame: Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment, and 6 and 12 months after the treatment.
  description: Measures the severity of insomnia and consists of seven questions regarding the individual's experience of insomnia with response options on a five-point Likert scale from 0-4. HIgher values indicating more severe insomna.
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.s.
  description: The PHQ-9 consists of nine questions designed according to diagnostic criteria for major depression in the DSM-5, as well as a question on level of functioning.Higher values indicating worse outcome.
  measure: The Generalized Anxiety Disorder (GAD-7)
  time frame: Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.
  description: Questionnaire which is a seven-item, self-report anxiety questionnaire designed to assess feelings of anxiety and worrying (Spitzer 2006). Each item is scored on a Likert scale between 0 and 3 and totaled for a score of 0 to 21. Higher score indicating worse outcome.
  measure: Fatigue Severity Scale (FSS)
  time frame: Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.
  description: Consists of nine questions with response options on a seven-point Likert scale 1 - 7 (Krupp et al, 1989). The total score is divided by the number of questions to give a mean score between 1 - 7. The higher the score, the more severe the fatigue..
  measure: The Brunnsviken Brief Quality of Life Scale (BBQ)
  time frame: Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment, and 6 and 12 months after the treatment.
  description: The BBQ comprise twelve items corresponding to satisfaction and importance of six life areas (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) and provides a total score between 0 and 96 with a higher score representing a higher level of quality of life.
  measure: Negative effects
  time frame: After the intervention.
  description: Negative effects of the treatment were assessed with a questionnaire comprising 12 items regarding common symptoms such as fatigue, dizziness, and negative mood
  measure: Sleep diary- Sleep onset latensy (SOL)
  time frame: Baseline, daily through study completion, up to 8 weeks
  description: It is measured in minutes and calculated. The participant will register this in the sleep diary.
  measure: Sleep diary- wake after sleep onset (WASO)
  time frame: Baseline, daily through study completion, up to 8 weeks
  description: It is measured in minutes and calculated. The participant will register this in the sleep diary.
  measure: Sleep diary. early morning awakening (EMA)
  time frame: Baseline, daily through study completion, up to 8 weeks
  description: It is measured in minutes and calculated. The participant will register this in the sleep diary.
  measure: Multiple Sclerosis Impact Scale (MSIS-29)
  time frame: Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.
  description: The MSIS-29 measures physical and psychological impact of MS. Items on the MSIS-29 have a Likert scale format (range 1.00-5.00); higher scores indicate a greater degree of disability. Total score is derived by summing items and transforming them into a score out of 100; higher scores imply a greater degree of disability.
  measure: Client Satisfaction Questionnaire-8 (CSQ-8)
  time frame: After the treatment that is 6 to 8 weeks after entering the treatment
  description: It is a brief global measure of client satisfaction..The CSQ-8 comprises eight items regarding service satisfaction that are scored on a 4-point Likert scale and provides a total score between 8 and 32. Higher values indicating higher satisfaction.
  measure: The severity of MS - MS check
  time frame: Screening
  description: The MS check which is a self-assessment questionnaire consisting of 14 questions concerning fatigue, cognition, mood, vision, speech/communication, and other bodily functions scored on a scale from 0 to 3. Higher scores indicating more severe disability and symptoms related to MS.
  measure: The Credibility/Expectancy Questionnaire
  time frame: Will be administered after the first treament week.
  description: The questionnaire contains 6 items rated on a 1-9 or a 0%-100% scale, depending upon the item. In the credibility factor the items explore: if the treatment appears logical; if the treatment appears useful; and if the treatment is reliable.
  arm group label: i-CBT
  arm group type: Experimental
  description: Cognitive behavioral therapy for insomnia with adjustment for MS.
  arm group label: Applied relaxation
  arm group type: Active Comparator
  description: Applied relaxation with adjustments for MS.
  intervention type: Behavioral
  intervention name: i-CBT
  description: The content is based on manual by Perlis et al (2015) and has slightly reworked by the research team by shortening treatment from seven to six sessions and allowing for day-time naps that may be necessary for patient with MS (Siengsukon et al. 2020). Due to the high prevalence of fatigue in people with MS, naps during the day may be a necessity to cope with everyday tasks. In cases where patients could not refrain from naps, they were advised to limit them to maximum 20 minutes and to take them as early in the day as possible. Other components are sleep restriction, sleep hygiene, stimulus control and cognitive techniques..
  arm group label: i-CBT
  intervention type: Behavioral
  intervention name: Applied relaxation
  description: Treatment consits of 6 modules. The main components in the training program will be progressive muscle relaxation, short relaxation with release only and without tension, and finally the participants will be taught rapid relaxation.
  arm group label: Applied relaxation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Monica Buhrman, phd
  role: Principal Investigator
  affiliation: Uppsala University
  last name: Monica Buhrman, phd
  phone: +46733468539
  email: Monica.Buhrman@psyk.uu.se
  last name: Markus Jansson Fröjmark, phd
  email: markus.jansson-frojmark@ki.se
  facility: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Uppsala University
  investigator full name: Monica Buhrman
  investigator title: Associate professor
  mesh term: Multiple Sclerosis
  mesh term: Sleep Initiation and Maintenance Disorders
  mesh term: Sclerosis