<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/NCT01731223</url>
  </required_header>
  <id_info>
    <org_study_id>CeFAM, Karolinska Institutet</org_study_id>
    <nct_id>NCT01731223</nct_id>
  </id_info>
  <brief_title>Group Treatment for Insomnia in Primary Health Care</brief_title>
  <acronym>Sleep Prime</acronym>
  <official_title>Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeanette Westman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to analyze if group treatment is effective to treat insomnia in&#xD;
      primary healthcare.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insomnia is a common health problem. Untreated insomnia may lead to decreased physical and&#xD;
      mental health. The patients turns to Primary Health Care when daytime symptoms decrease&#xD;
      social and occupational function. Previous studies have shown that cognitive and behavioral&#xD;
      therapy have effects on insomnia and recommends as first line treatment but is not widely&#xD;
      available in primary health care.&#xD;
&#xD;
      The purpose is to test the effect of group intervention in Primary Health Care for patients&#xD;
      with insomnia. The outcomes is insomnia severity, sleep habits, use of hypnotics, Fatigue,&#xD;
      general health and health related quality of life. Characters with insomnia visiting in&#xD;
      Primary Health Care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia severity Index</measure>
    <time_frame>One year</time_frame>
    <description>Insomnia Severity Index (ISI)is a seven item self assessment scale measuring severity of insomnia symptoms during the last two weeks. The items asks about sleep disturbance, daytime functioning and worrying about sleep. The possibly response is 0 &quot;None&quot; 1 &quot;Mild&quot; 2 &quot;Moderate&quot; 3 &quot;Severe&quot; 4 &quot;Very severe&quot;. The sum is added and 0-7 p grades the insomnia to &quot;none clinically significant insomnia&quot;, 8-14 p &quot;subtreshold insomnia&quot;, 15-21 p &quot;moderate insomnia&quot;, 22-28 p &quot;severe insomnia&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue severity scale</measure>
    <time_frame>one year</time_frame>
    <description>Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sleep Logg</measure>
    <time_frame>one year</time_frame>
    <description>Sleep log for every night during two weeks. The patient logs time going to bed, sleep latency, awakes during the night, time going up from bed in the morning, total sleep time, sleep quality graded from 1-5. ! is very bad and 5 is very good). Use of alcohol, hypnotics and herbs are noted</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Group treatment for insomnia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group treatment for insomnia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group treatment for insomnia</intervention_name>
    <description>Experimental: Group treatment of insomnia The intervention is a group treatment based on cognitive and behavioral changing methods. It is including seven sessions during 10 weeks. Each session last for 2 hours with a 20 minutes pause. The intervention includes psycho education about sleep. Methods as relaxation, coping with worry, sleep restriction, stimulus control, sleep hygiene, stress coping strategies, strategies for coping with daytime symptom, identify and reformulate negative and dysfunctional thoughts about sleep, daytime functioning and stress and strategies for reducing hypnotics.</description>
    <arm_group_label>Group treatment for insomnia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Insomnia symptoms regarding DSM-V&#xD;
&#xD;
          -  Motivated to group treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insomnia Severity Index less than 7 points&#xD;
&#xD;
          -  Presence of acute life crises, acute psychiatric illness, bipolar disorder&#xD;
&#xD;
          -  Shift work&#xD;
&#xD;
          -  Linguistic or cognitive difficulties causing inability participate in group or fill in&#xD;
             forms&#xD;
&#xD;
          -  Insomnia directly caused by medical illness. Other sleep disorder.&#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>Jeanette Westman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet, Stockholm, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for family medicine</name>
      <address>
        <city>Stockholm</city>
        <state>Huddinge</state>
        <zip>14183</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum för allmanmedicin</name>
      <address>
        <city>Stockholm</city>
        <state>Huddinge</state>
        <zip>14183</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://www.cefam.se</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>LeBlanc M, Beaulieu-Bonneau S, Merette C, Savard J, Ivers H, Morin CM. Psychological and health-related quality of life factors associated with insomnia in a population-based sample. J Psychosom Res. 2007 Aug;63(2):157-66. doi: 10.1016/j.jpsychores.2007.03.004.</citation>
    <PMID>17662752</PMID>
  </reference>
  <reference>
    <citation>Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, Britton TC, Crowe C, Dijk DJ, Espie CA, Gringras P, Hajak G, Idzikowski C, Krystal AD, Nash JR, Selsick H, Sharpley AL, Wade AG. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. doi: 10.1177/0269881110379307. Epub 2010 Sep 2.</citation>
    <PMID>20813762</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Jeanette Westman</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Primary health care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01731223
org study id: CeFAM, Karolinska Institutet
nct id: NCT01731223
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study is to analyze if group treatment is effective to treat insomnia in
      primary healthcare.
Insomnia is a common health problem. Untreated insomnia may lead to decreased physical and
      mental health. The patients turns to Primary Health Care when daytime symptoms decrease
      social and occupational function. Previous studies have shown that cognitive and behavioral
      therapy have effects on insomnia and recommends as first line treatment but is not widely
      available in primary health care.

      The purpose is to test the effect of group intervention in Primary Health Care for patients
      with insomnia. The outcomes is insomnia severity, sleep habits, use of hypnotics, Fatigue,
      general health and health related quality of life. Characters with insomnia visiting in
      Primary Health Care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Insomnia severity Index
time frame: One year
description: Insomnia Severity Index (ISI)is a seven item self assessment scale measuring severity of insomnia symptoms during the last two weeks. The items asks about sleep disturbance, daytime functioning and worrying about sleep. The possibly response is 0 "None" 1 "Mild" 2 "Moderate" 3 "Severe" 4 "Very severe". The sum is added and 0-7 p grades the insomnia to "none clinically significant insomnia", 8-14 p "subtreshold insomnia", 15-21 p "moderate insomnia", 22-28 p "severe insomnia".
measure: Fatigue severity scale
time frame: one year
description: Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points
measure: Sleep Logg
time frame: one year
description: Sleep log for every night during two weeks. The patient logs time going to bed, sleep latency, awakes during the night, time going up from bed in the morning, total sleep time, sleep quality graded from 1-5. ! is very bad and 5 is very good). Use of alcohol, hypnotics and herbs are noted
arm group label: Group treatment for insomnia
arm group type: Experimental
description: Group treatment for insomnia.
arm group label: No intervention
arm group type: No Intervention
description: Treatment as usual
intervention type: Behavioral
intervention name: Group treatment for insomnia
description: Experimental: Group treatment of insomnia The intervention is a group treatment based on cognitive and behavioral changing methods. It is including seven sessions during 10 weeks. Each session last for 2 hours with a 20 minutes pause. The intervention includes psycho education about sleep. Methods as relaxation, coping with worry, sleep restriction, stimulus control, sleep hygiene, stress coping strategies, strategies for coping with daytime symptom, identify and reformulate negative and dysfunctional thoughts about sleep, daytime functioning and stress and strategies for reducing hypnotics.
arm group label: Group treatment for insomnia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeanette Westman, PhD
role: Principal Investigator
affiliation: Karolinska Institutet, Stockholm, Sweden
facility: 
facility: 
country: Sweden
url: http://www.cefam.se
description: Related Info
citation: LeBlanc M, Beaulieu-Bonneau S, Merette C, Savard J, Ivers H, Morin CM. Psychological and health-related quality of life factors associated with insomnia in a population-based sample. J Psychosom Res. 2007 Aug;63(2):157-66. doi: 10.1016/j.jpsychores.2007.03.004.
PMID: 17662752
citation: Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, Britton TC, Crowe C, Dijk DJ, Espie CA, Gringras P, Hajak G, Idzikowski C, Krystal AD, Nash JR, Selsick H, Sharpley AL, Wade AG. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. doi: 10.1177/0269881110379307. Epub 2010 Sep 2.
PMID: 20813762
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Jeanette Westman
investigator title: PhD
mesh term: Sleep Initiation and Maintenance Disorders