<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/NCT03014960</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000461-B</org_study_id>
    <nct_id>NCT03014960</nct_id>
  </id_info>
  <brief_title>Effects of Leader Sleep Improvement on Leadership</brief_title>
  <official_title>The Effects of Leader Sleep Improvement on Leadership</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</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 purpose of the study is to investigate the effects of sleep improvement in leaders on&#xD;
      leader outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators seek to extend the findings of a recent research which demonstrated that&#xD;
      treating insomnia has several beneficial effects on employee work outcomes (Barnes, Miller, &amp;&#xD;
      Bostock, in press). In the present study, the investigators propose that the treatment of&#xD;
      leader insomnia would beneficially influence leadership, specifically abusive supervision,&#xD;
      charismatic leadership, and laissez-faire leadership.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Control Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Rate self-control over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abusive Supervision Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Rate abusive supervision over the past 2 weeks. Each item is scored 1-5:&#xD;
- I cannot remember him/her ever using this behavior with me&#xD;
- He/she very seldom uses this behavior with me&#xD;
- He/she occasionally uses this behavior with me&#xD;
- He/she uses this behavior moderately often with me&#xD;
- He/she uses this behavior very often with me</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Labor Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Rate emotional labor over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Charismatic Leadership Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Rate charismatic leadership over the past 2 weeks. Each item is scored 1-5 (1 = to a very little extent; 2 = to a little extent; 3 = to a moderate extent; 4 = to a great extent; 5 = to a very great extent).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Exhaustion Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Rate emotional exhaustion over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laissez-Faire Leadership Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Rate laissez-faire leadership over the past 2 weeks. Each item is scored 1-5 (1 = to a very little extent; 2 = to a little extent; 3 = to a moderate extent; 4 = to a great extent; 5 = to a very great extent).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insomnia Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Rate insomnia over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Very much)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Insomnia, Primary</condition>
  <condition>Chronic Insomnia</condition>
  <arm_group>
    <arm_group_label>Experimental Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online Cognitive Behavioral Therapy for Insomnia Intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Condition</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online Cognitive Behavioral Therapy for Insomnia (CBT-I)</intervention_name>
    <description>CBT-I is a psychological treatment designed to break the patterns of maladaptive thinking and behavior that maintain insomnia. CBT-I includes a range of techniques including a behavioral component (stimulus control, sleep restriction, relaxation) combined with a cognitive component (managing sleep related worries, the racing mind and intrusive thoughts) and an educational (sleep hygiene) component.</description>
    <arm_group_label>Experimental Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Working adults who have at least one direct report (i.e., subordinate).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Non-working adults/ adults who do not have at least one direct report (i.e.,&#xD;
             subordinate).&#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>Yu Tse Heng</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yu Tse Heng</last_name>
    <phone>412-517-2941</phone>
    <email>yutse@uw.edu</email>
  </overall_contact>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Yu Tse Heng</investigator_full_name>
    <investigator_title>Doctoral Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014960
org study id: STUDY00000461-B
nct id: NCT03014960
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to investigate the effects of sleep improvement in leaders on
      leader outcomes.
The investigators seek to extend the findings of a recent research which demonstrated that
      treating insomnia has several beneficial effects on employee work outcomes (Barnes, Miller, &
      Bostock, in press). In the present study, the investigators propose that the treatment of
      leader insomnia would beneficially influence leadership, specifically abusive supervision,
      charismatic leadership, and laissez-faire leadership.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Self-Control Scale
time frame: 2 weeks
description: Rate self-control over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
measure: Abusive Supervision Scale
time frame: 2 weeks
description: Rate abusive supervision over the past 2 weeks. Each item is scored 1-5:
- I cannot remember him/her ever using this behavior with me
- He/she very seldom uses this behavior with me
- He/she occasionally uses this behavior with me
- He/she uses this behavior moderately often with me
- He/she uses this behavior very often with me
measure: Emotional Labor Scale
time frame: 2 weeks
description: Rate emotional labor over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
measure: Charismatic Leadership Scale
time frame: 2 weeks
description: Rate charismatic leadership over the past 2 weeks. Each item is scored 1-5 (1 = to a very little extent; 2 = to a little extent; 3 = to a moderate extent; 4 = to a great extent; 5 = to a very great extent).
measure: Emotional Exhaustion Scale
time frame: 2 weeks
description: Rate emotional exhaustion over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
measure: Laissez-Faire Leadership Scale
time frame: 2 weeks
description: Rate laissez-faire leadership over the past 2 weeks. Each item is scored 1-5 (1 = to a very little extent; 2 = to a little extent; 3 = to a moderate extent; 4 = to a great extent; 5 = to a very great extent).
measure: Insomnia Scale
time frame: 2 weeks
description: Rate insomnia over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Very much)
arm group label: Experimental Condition
arm group type: Experimental
description: Online Cognitive Behavioral Therapy for Insomnia Intervention
arm group label: Control Condition
arm group type: No Intervention
description: No intervention
intervention type: Other
intervention name: Online Cognitive Behavioral Therapy for Insomnia (CBT-I)
description: CBT-I is a psychological treatment designed to break the patterns of maladaptive thinking and behavior that maintain insomnia. CBT-I includes a range of techniques including a behavioral component (stimulus control, sleep restriction, relaxation) combined with a cognitive component (managing sleep related worries, the racing mind and intrusive thoughts) and an educational (sleep hygiene) component.
arm group label: Experimental Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yu Tse Heng
role: Principal Investigator
affiliation: University of Washington
last name: Yu Tse Heng
phone: 412-517-2941
email: yutse@uw.edu
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Yu Tse Heng
investigator title: Doctoral Student
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No