<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/NCT04463498</url>
  </required_header>
  <id_info>
    <org_study_id>66304</org_study_id>
    <nct_id>NCT04463498</nct_id>
  </id_info>
  <brief_title>Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia</brief_title>
  <acronym>SIP</acronym>
  <official_title>Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haukeland University Hospital</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>
      Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often&#xD;
      treated with medication or not at all in psychiatric care, although there exist a plethora of&#xD;
      documentation of the effectiveness of sleep interventions. There is also an increase in&#xD;
      studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with&#xD;
      psychiatric illness. The most common and best documented treatment for insomnia is cognitive&#xD;
      behavioral therapy for insomnia (CBTi). There is a great gap in the knowledge on how sleep&#xD;
      disorders can be treated effectively in psychiatric care. In this project the investigators&#xD;
      therefore seek to investigate the effect of non-pharmacological, group-based treatment in a&#xD;
      randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary&#xD;
      outcome measures. CBTi comprise of sleep education, sleep restriction, stimulus control and&#xD;
      cognitive restructuring of dysfunctional thoughts about sleep.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The recommended treatment for insomnia is CBTi. Recent research has proven that dark therapy,&#xD;
      or blocking light in wavelengths &lt;530 nm by the use of for example orange blue-blocking&#xD;
      glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to&#xD;
      darkness and to have an additive effect in the treatment of insomnia. The investigators&#xD;
      therefore also want to test bb-glasses as an additive treatment to CBTi for insomnia.&#xD;
&#xD;
      The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established&#xD;
      treatment since 2017. The insomnia-group gets together every other Monday from noon until 2&#xD;
      pm. The group is open, which means that participants start at different dates and meet people&#xD;
      in the group that might be at the end of their CBTi treatment. Participants are patients at&#xD;
      the general psychiatric outpatient clinic at Bjørgvin DPS. Participant have been referred to&#xD;
      the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on&#xD;
      the same structure for the group for participants that are recruited to the RCT.&#xD;
&#xD;
      All participants have an individual consultation before joining the group where the focus is&#xD;
      on eligibility to participate in the group-based treatment, diagnostic evaluation, receive a&#xD;
      standardized education on sleep-regulation and sleep hygiene advice and receive a date to&#xD;
      start the group-based CBTi treatment. In a randomized manner, they will be allocated to the&#xD;
      sleep-school group and start the treatment on the next possible date or to a 8 week wait-list&#xD;
      and receive a date the treatment starts. All eligible participants will be informed that&#xD;
      there may be a waitlist and receive a start-date without being informed that thay are in a&#xD;
      waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for&#xD;
      their psychiatric problems parallel to either sleep-school or waitlist. Participants that&#xD;
      start sleep-school as soon as possible, are also allocated to a) ordinary group-based CBTi 8&#xD;
      weeks or b) group-based CBTi 8 weeks and bb-glasses. All participant will be followed up&#xD;
      after 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</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 (Participant)</masking>
    <masking_description>All eligible participants will be informed that there may be a waitlist (length not specified) and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in anxiety and depression</measure>
    <time_frame>baseline, bi-weekly assesment (HADS) and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the Hospital anxiety and depression scale (HADS), Becks Depression Inventory -II (BDI-II) and Becks Anxiety Inventory (BAI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insomnia symptoms</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the questionnaires Insomnia severity Index (ISI) and Bergen Insomnia Scale (BIS). From sleep diaries; SOL, WASO and SE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in insomnia diagnosis</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the Bergen Bergen Insomnia Scale (BIS). The BIS measure subjective symptoms of insomnia during the previous week and give a total score (minimum 0, maximum 42; the higher the score, the worse severity of insomnia) and a clinical incidence of insomnia diagnosis-score (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in insomnia severity</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the Insomnia Severity Index (ISI). The ISI is a 7-item scale assessing the perceived severity of insomnia symptoms (initial, middle, terminal), the degree of satisfaction with sleep, interference with daytime functioning, noticeability of impairment, and concern caused by the sleep problems. The scale is Likert-type with 5 anchor points ranging from 0 to 4. The scale ranges from 0 to 28 and the higher the score, the more severe insomnia. The usual time frame for responding is the last 2 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Time in bed (TIB)</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by sleep diary; time from bed-time to rise time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective early morning awakening (EMA)</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes early morning awakening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective wake after sleep onset (WASO)</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes awake after sleep onset.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Early morning awakening (EMA)</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by sleep diary; minutes awake before rise time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective time in bed (TIB)</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average time in bed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective sleep efficiency (SE)</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number from 0-100% that gives average sleep efficiency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective total sleep length/time asleep (TST),</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average total sleep time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Sleep onset latency (SOL)</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by sleep diary; time in minutes from bed-time to estimated sleep onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Total sleep length/time asleep (TST)</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by sleep diary: Time in bed minus time awake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Wake after sleep onset (WASO)</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by sleep diary; minutes awake after sleep onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Sleep quality (SQ)</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by sleep diary; subjective assesment of sleep quality on a scale from 1=very light to 5=very deep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Daytime function (DF)</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Sleep efficiency (SE)</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by sleep diary; total sleep time/time in bed x 100= percentage SE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective sleep onset latency (SOL)</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of minutes of average sleep onset latency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in beliefs about sleep</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by Dysfunctional Beliefs About Sleep (DBAS-16). The DBAS-16 measures the degree of dysfunctional beliefs about sleep with 16 items. It has 4 subscales (1) sleep-related worry and helplessness; 2) beliefs about sleep medications; 3) expectations about sleep need; and 4) beliefs about the consequences/effects of insomnia and 1 total scale score. The higher the score, the more dysfunctional beliefs about sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction</measure>
    <time_frame>post intervention after 8 weeks</time_frame>
    <description>Measured by the Client Satisfaction Questionnaire (CSQ8). The CSQ-8 is an 8-item questionnaire that measures patient satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very high satisfaction). The total score ranges from 8 to 32, with higher scores indicating higher degrees of satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>We will measure systolic and diastolic pressure by a digital blood pressure measurement machine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicide attempts and admittances in psychiatric wards</measure>
    <time_frame>baseline and post intervention after 8 weeks, and at follow-up after 12 months</time_frame>
    <description>Whether or not suicide has been attempted, if applicable number og attempts and whether or nor the patient has been admitted to a psychitaric ward (voluntary/forced)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in immediate sleepiness</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the Karolinska Sleepiness Scale (KSS). The KSS measure subjective sleepiness at a specific time point (noon). The scale gives a number from 1-9 where 9 indicates &quot;trouble staying awake&quot; and is the worst outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sleepiness</measure>
    <time_frame>baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the Epworth Sleepiness Scale (ESS). The ESS is an 8-item scale where the respondent grades the likelihood of falling asleep or dozing off in different daily situations. The responses are graded on a 4-point likert scale 0=no likelihodd to 3=very likely. A score of 11 or higher is considered an indication of excessive daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Heart rate variability (HRV)</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>24 -hour HRV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work status</measure>
    <time_frame>baseline and post intervention after 8 weeks, and at follow-up after 12 months</time_frame>
    <description>Status of employment/unemployment, percentage disability benefits received</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in degree of experienced pain</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by a visual analogue scale (VAS Pain) ranging from 0 to 10. The higher the score, the worse the pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in self reported emotion regulation ability</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by Difficulties in Emotion Regulation Scale (DERS) which is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 (&quot;almost never [0-10%]&quot;) to 5 (&quot;almost always [91-100%]&quot;). Higher scores suggest greater problems with emotion regulation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in vigilance</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the Conners Continuous Performance (CPT) Test 3rd Edition™ (Conners CPT 3™)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in symptoms of inattention</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the Adult attention deficit hyperactivity disorder (ADHD) Self-Rating Scale (ASRS). The scale contains the 18 symptoms of inattention, hyperactivity, and impulsivity defining ADHD according to the DSM-IV-TR and DSM-5. The severity of the symptoms are reported on a 5-point Likert-type scale (0-4 = never, rarely, sometimes, often, to very often), with a total range of 0-72. The higher the score, the more symptoms of inattention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in symptoms of hypochondria</measure>
    <time_frame>baseline and post intervention after 8 weeks, follow-up after 12 months</time_frame>
    <description>Measured by the The Whiteley Index (WI). The 14-item WI measures assess health anxiety on a likert-scale from 1=&quot;not at all&quot; to &quot;5=very much&quot;. The higher the score, the more severe health anxiety.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sleep Disorder; Insomnia Type</condition>
  <condition>Psychiatric Disorders</condition>
  <arm_group>
    <arm_group_label>n=15, Sleep-school 8 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>n=15, Sleep-school 8 weeks and additive bb-glasses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>n=30 8-week wait list for sleep-school</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive treatment as usual in the psychiatric clinic while they wait for participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group-based cognitive behavioral therapy for insomnia</intervention_name>
    <description>Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques</description>
    <arm_group_label>n=15, Sleep-school 8 weeks</arm_group_label>
    <arm_group_label>n=15, Sleep-school 8 weeks and additive bb-glasses</arm_group_label>
    <other_name>Group - CBTi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group-based cognitive behavioral therapy for insomnia and additive bb-glasses</intervention_name>
    <description>Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.</description>
    <arm_group_label>n=15, Sleep-school 8 weeks and additive bb-glasses</arm_group_label>
    <other_name>Group - CBTi &amp; bb-glasses</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>8-week wait list for sleep-school</intervention_name>
    <description>Treatment as usual in a psychiatric outpatient clinic</description>
    <arm_group_label>n=30 8-week wait list for sleep-school</arm_group_label>
    <other_name>Treatment as usual</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital&#xD;
&#xD;
          -  Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for&#xD;
             insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis&#xD;
             based on the International Statistical Classification of Diseases and Related Health&#xD;
             Problems (ICD-11) diagnostic system that are used in Norway in addition to insomnia&#xD;
             and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the&#xD;
             sleep school)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nightwork&#xD;
&#xD;
          -  Patients that do not fulfil the DSM-V criteria for insomnia comorbid to moderate to&#xD;
             severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic&#xD;
             system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI&#xD;
             and/or scores of ≥16 on BAI at the time of referral to the sleep school)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ane Wilhelmsen-Langeland, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haukeland University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ane Wilhelmsen-Langeland, PhD</last_name>
    <phone>+47 55957000</phone>
    <email>ane.wilhelmsen-langeland@helse-bergen.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Berge Osnes, PhD</last_name>
    <phone>+47 55957000</phone>
    <email>berge.osnes@helse-bergen.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5113</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ane Wilhelmsen-Langeland, PhD</last_name>
      <phone>+47 92843253</phone>
      <email>ane.wilhelmsen-langeland@helse-bergen.no</email>
    </contact>
    <contact_backup>
      <last_name>Berge Osnes, PhD</last_name>
      <phone>+47 92445081</phone>
      <email>berge.osnes@helse-bergen.no</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>April 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sleep disorders</keyword>
  <keyword>insomnia</keyword>
  <keyword>psychiatric disorders</keyword>
  <keyword>bb-glasses</keyword>
  <keyword>group-based cognitive behavioural therapy for insomnia</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>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators plan to share the following individual participant data (IPD); Study protocol and Informed Consent Form (ICF)&#xD;
IPD Sharing Time Frame Definition: A description of when the IPD and any additional supporting information will become available and for how long, including the start and end dates or period of availability. This may be provided as an absolute date (for example, starting in January 2025) or as a date relative to the time when summary data are published or otherwise made available (for example, starting 6 months after publication).&#xD;
Limit: 1000 characters.&#xD;
IPD Sharing Access Criteria Definition: Describe by what access criteria IPD and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism. Information about who will review requests and criteria for reviewing requests may also be provided.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>By August 31st 2025</ipd_time_frame>
    <ipd_access_criteria>Not yet decided. PI will be reviewing requests.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 9, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT04463498/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04463498
org study id: 66304
nct id: NCT04463498
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often
      treated with medication or not at all in psychiatric care, although there exist a plethora of
      documentation of the effectiveness of sleep interventions. There is also an increase in
      studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with
      psychiatric illness. The most common and best documented treatment for insomnia is cognitive
      behavioral therapy for insomnia (CBTi). There is a great gap in the knowledge on how sleep
      disorders can be treated effectively in psychiatric care. In this project the investigators
      therefore seek to investigate the effect of non-pharmacological, group-based treatment in a
      randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary
      outcome measures. CBTi comprise of sleep education, sleep restriction, stimulus control and
      cognitive restructuring of dysfunctional thoughts about sleep.
The recommended treatment for insomnia is CBTi. Recent research has proven that dark therapy,
      or blocking light in wavelengths <530 nm by the use of for example orange blue-blocking
      glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to
      darkness and to have an additive effect in the treatment of insomnia. The investigators
      therefore also want to test bb-glasses as an additive treatment to CBTi for insomnia.

      The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established
      treatment since 2017. The insomnia-group gets together every other Monday from noon until 2
      pm. The group is open, which means that participants start at different dates and meet people
      in the group that might be at the end of their CBTi treatment. Participants are patients at
      the general psychiatric outpatient clinic at Bjørgvin DPS. Participant have been referred to
      the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on
      the same structure for the group for participants that are recruited to the RCT.

      All participants have an individual consultation before joining the group where the focus is
      on eligibility to participate in the group-based treatment, diagnostic evaluation, receive a
      standardized education on sleep-regulation and sleep hygiene advice and receive a date to
      start the group-based CBTi treatment. In a randomized manner, they will be allocated to the
      sleep-school group and start the treatment on the next possible date or to a 8 week wait-list
      and receive a date the treatment starts. All eligible participants will be informed that
      there may be a waitlist and receive a start-date without being informed that thay are in a
      waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for
      their psychiatric problems parallel to either sleep-school or waitlist. Participants that
      start sleep-school as soon as possible, are also allocated to a) ordinary group-based CBTi 8
      weeks or b) group-based CBTi 8 weeks and bb-glasses. All participant will be followed up
      after 12 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Single (Participant)
masking description: All eligible participants will be informed that there may be a waitlist (length not specified) and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group.
measure: Changes in anxiety and depression
time frame: baseline, bi-weekly assesment (HADS) and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the Hospital anxiety and depression scale (HADS), Becks Depression Inventory -II (BDI-II) and Becks Anxiety Inventory (BAI).
measure: Insomnia symptoms
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the questionnaires Insomnia severity Index (ISI) and Bergen Insomnia Scale (BIS). From sleep diaries; SOL, WASO and SE.
measure: Changes in insomnia diagnosis
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the Bergen Bergen Insomnia Scale (BIS). The BIS measure subjective symptoms of insomnia during the previous week and give a total score (minimum 0, maximum 42; the higher the score, the worse severity of insomnia) and a clinical incidence of insomnia diagnosis-score (yes/no)
measure: Changes in insomnia severity
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the Insomnia Severity Index (ISI). The ISI is a 7-item scale assessing the perceived severity of insomnia symptoms (initial, middle, terminal), the degree of satisfaction with sleep, interference with daytime functioning, noticeability of impairment, and concern caused by the sleep problems. The scale is Likert-type with 5 anchor points ranging from 0 to 4. The scale ranges from 0 to 28 and the higher the score, the more severe insomnia. The usual time frame for responding is the last 2 weeks.
measure: Changes in Time in bed (TIB)
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by sleep diary; time from bed-time to rise time
measure: Changes in objective early morning awakening (EMA)
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes early morning awakening.
measure: Changes in objective wake after sleep onset (WASO)
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes awake after sleep onset.
measure: Changes in Early morning awakening (EMA)
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by sleep diary; minutes awake before rise time
measure: Changes in objective time in bed (TIB)
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average time in bed.
measure: Changes in objective sleep efficiency (SE)
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number from 0-100% that gives average sleep efficiency.
measure: Changes in objective total sleep length/time asleep (TST),
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average total sleep time.
measure: Changes in Sleep onset latency (SOL)
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by sleep diary; time in minutes from bed-time to estimated sleep onset
measure: Changes in Total sleep length/time asleep (TST)
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by sleep diary: Time in bed minus time awake
measure: Changes in Wake after sleep onset (WASO)
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by sleep diary; minutes awake after sleep onset
measure: Changes in Sleep quality (SQ)
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by sleep diary; subjective assesment of sleep quality on a scale from 1=very light to 5=very deep
measure: Changes in Daytime function (DF)
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor
measure: Changes in Sleep efficiency (SE)
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by sleep diary; total sleep time/time in bed x 100= percentage SE
measure: Changes in objective sleep onset latency (SOL)
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of minutes of average sleep onset latency.
measure: Changes in beliefs about sleep
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by Dysfunctional Beliefs About Sleep (DBAS-16). The DBAS-16 measures the degree of dysfunctional beliefs about sleep with 16 items. It has 4 subscales (1) sleep-related worry and helplessness; 2) beliefs about sleep medications; 3) expectations about sleep need; and 4) beliefs about the consequences/effects of insomnia and 1 total scale score. The higher the score, the more dysfunctional beliefs about sleep.
measure: Client Satisfaction
time frame: post intervention after 8 weeks
description: Measured by the Client Satisfaction Questionnaire (CSQ8). The CSQ-8 is an 8-item questionnaire that measures patient satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very high satisfaction). The total score ranges from 8 to 32, with higher scores indicating higher degrees of satisfaction.
measure: Changes in blood pressure
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: We will measure systolic and diastolic pressure by a digital blood pressure measurement machine.
measure: Suicide attempts and admittances in psychiatric wards
time frame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
description: Whether or not suicide has been attempted, if applicable number og attempts and whether or nor the patient has been admitted to a psychitaric ward (voluntary/forced)
measure: Changes in immediate sleepiness
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the Karolinska Sleepiness Scale (KSS). The KSS measure subjective sleepiness at a specific time point (noon). The scale gives a number from 1-9 where 9 indicates "trouble staying awake" and is the worst outcome.
measure: Changes in sleepiness
time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the Epworth Sleepiness Scale (ESS). The ESS is an 8-item scale where the respondent grades the likelihood of falling asleep or dozing off in different daily situations. The responses are graded on a 4-point likert scale 0=no likelihodd to 3=very likely. A score of 11 or higher is considered an indication of excessive daytime sleepiness.
measure: Changes in Heart rate variability (HRV)
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: 24 -hour HRV.
measure: Work status
time frame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
description: Status of employment/unemployment, percentage disability benefits received
measure: Changes in degree of experienced pain
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by a visual analogue scale (VAS Pain) ranging from 0 to 10. The higher the score, the worse the pain.
measure: Changes in self reported emotion regulation ability
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by Difficulties in Emotion Regulation Scale (DERS) which is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores suggest greater problems with emotion regulation.
measure: Changes in vigilance
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the Conners Continuous Performance (CPT) Test 3rd Edition™ (Conners CPT 3™)
measure: Changes in symptoms of inattention
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the Adult attention deficit hyperactivity disorder (ADHD) Self-Rating Scale (ASRS). The scale contains the 18 symptoms of inattention, hyperactivity, and impulsivity defining ADHD according to the DSM-IV-TR and DSM-5. The severity of the symptoms are reported on a 5-point Likert-type scale (0-4 = never, rarely, sometimes, often, to very often), with a total range of 0-72. The higher the score, the more symptoms of inattention.
measure: Changes in symptoms of hypochondria
time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
description: Measured by the The Whiteley Index (WI). The 14-item WI measures assess health anxiety on a likert-scale from 1="not at all" to "5=very much". The higher the score, the more severe health anxiety.
arm group label: n=15, Sleep-school 8 weeks
arm group type: Experimental
description: Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.
arm group label: n=15, Sleep-school 8 weeks and additive bb-glasses
arm group type: Experimental
description: Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.
arm group label: n=30 8-week wait list for sleep-school
arm group type: Active Comparator
description: Patients receive treatment as usual in the psychiatric clinic while they wait for participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.
intervention type: Behavioral
intervention name: Group-based cognitive behavioral therapy for insomnia
description: Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques
arm group label: n=15, Sleep-school 8 weeks
arm group label: n=15, Sleep-school 8 weeks and additive bb-glasses
other name: Group - CBTi
intervention type: Behavioral
intervention name: Group-based cognitive behavioral therapy for insomnia and additive bb-glasses
description: Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.
arm group label: n=15, Sleep-school 8 weeks and additive bb-glasses
other name: Group - CBTi & bb-glasses
intervention type: Other
intervention name: 8-week wait list for sleep-school
description: Treatment as usual in a psychiatric outpatient clinic
arm group label: n=30 8-week wait list for sleep-school
other name: Treatment as usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ane Wilhelmsen-Langeland, PhD
role: Principal Investigator
affiliation: Haukeland University Hospital
last name: Ane Wilhelmsen-Langeland, PhD
phone: +47 55957000
email: ane.wilhelmsen-langeland@helse-bergen.no
last name: Berge Osnes, PhD
phone: +47 55957000
email: berge.osnes@helse-bergen.no
facility: 
status: Recruiting
contact: 
contact backup: 
country: Norway
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Mental Disorders
mesh term: Problem Behavior
mesh term: Methamphetamine
sharing ipd: Yes
ipd description: The investigators plan to share the following individual participant data (IPD); Study protocol and Informed Consent Form (ICF)
IPD Sharing Time Frame Definition: A description of when the IPD and any additional supporting information will become available and for how long, including the start and end dates or period of availability. This may be provided as an absolute date (for example, starting in January 2025) or as a date relative to the time when summary data are published or otherwise made available (for example, starting 6 months after publication).
Limit: 1000 characters.
IPD Sharing Access Criteria Definition: Describe by what access criteria IPD and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism. Information about who will review requests and criteria for reviewing requests may also be provided.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: By August 31st 2025
ipd access criteria: Not yet decided. PI will be reviewing requests.
provided document: 