<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/NCT03804788</url>
  </required_header>
  <id_info>
    <org_study_id>2014239</org_study_id>
    <secondary_id>K23AA026895</secondary_id>
    <nct_id>NCT03804788</nct_id>
  </id_info>
  <brief_title>The iTAP Study for Veterans</brief_title>
  <acronym>iTAP-V</acronym>
  <official_title>The Impact of Insomnia Treatment on Heavy Alcohol Use Among Returning Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This project aims to evaluate improvement of insomnia as a mechanism of improvement in&#xD;
      alcohol use outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than half of returning Veterans who screen positive for hazardous drinking report&#xD;
      clinically significant symptoms of insomnia. In turn, insomnia symptoms have been associated&#xD;
      with increased risk of alcohol-related problems, perhaps due to insomnia-related impairments&#xD;
      in executive functioning, negative emotionality, and craving. The proposed project aims to&#xD;
      examine improvements in insomnia as a mechanism for improvement in alcohol use among&#xD;
      heavy-drinking Veterans with insomnia. Forty-four returning Veterans who report heavy&#xD;
      drinking (≥4/5 drinks per occasion for women/men) and have insomnia based on DSM-5 and&#xD;
      research diagnostic criteria will participate in a randomized pilot trial. Participants will&#xD;
      be randomly assigned to receive personalized normative alcohol feedback in the context of one&#xD;
      of two treatment conditions: CBT-I (n = 22) or a sleep hygiene education control (SH; n =&#xD;
      22). Outcomes will be assessed at the end of the active intervention period (6 weeks),&#xD;
      mid-treatment (after 3 sessions), and at 3 months post-intervention. Outcomes of interest&#xD;
      include insomnia severity, total wake time, sleep quality, drinking quantity/frequency,&#xD;
      alcohol-related consequences, executive functioning, negative affect, emotion regulation,&#xD;
      craving for alcohol, and use of alcohol as a sleep aid.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 4, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>Subjects will be randomized to receive sleep hygiene or to participate in sessions of individual Cognitive Behavioral Therapy for Insomnia (CBT-I).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>PI Miller will be blind to participant assignment because the project manager will inform study therapists of participant assignment to conditions. PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition. All participants will be told that they are receiving treatment for insomnia in order to blind them to condition assignment (sleep hygiene will be described as &quot;brief&quot; insomnia treatment, and CBT-I will be described as the &quot;most intense&quot; treatment).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>Assessed at post-treatment (weeks 7-8)</time_frame>
    <description>Number of participants who complete baseline assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>Assessed at post-treatment (weeks 7-8)</time_frame>
    <description>Number of participants who complete all treatment sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drinking quantity</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using Timeline Followback and Daily Drinking Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol-related consequences</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Brief Young Adult Alcohol Consequences Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insomnia symptoms</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using Insomnia Severity Index (ISI); ISI evaluates self-reports of insomnia experiences</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using daily sleep diaries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep efficiency</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using daily sleep diaries and actigraphy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Client satisfaction</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Client Satisfaction Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Working memory updating</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Keep Track task as described by Friedman et al (2008).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working memory updating</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the N-Back Task as described in Jaeggi et al (2010).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working memory updating</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Letter Memory task as described in Miyake &amp; Friedman (2012)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response inhibition</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Stop Signal task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported executive function</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Behavior Rating Inventory of Executive Function of Adults</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay discounting</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable; see Kirby, Petry, &amp; Bickel, 1999). Higher k values indicate a greater preference for smaller, immediate rewards over larger, delayed reward.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay discounting</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the 5-trial delay discounting task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative affect</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Positive and Negative Affect Schedule. Participants indicate using a 1 (not at all) - 5 (extremely) scale to indicate to what extent they feel negative emotions. The final score is the sum of the ten negative emotions/feelings. Higher scores indicate more negative affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion regulation</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). The DERS-16 is a shortened version of the DERS scale. It measures emotion dysregulation based on subscales of clarity, goals, strategies, impulses, and non-acceptance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol craving</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using the Penn Alcohol Craving Scale (PACS); PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of alcohol to help with sleep</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using daily sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of sleep medication</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using daily sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic arousal</measure>
    <time_frame>Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)</time_frame>
    <description>Assessed using holter monitoring devices that provide a physiological index of arousal in the autonomic nervous system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Insomnia</condition>
  <condition>Alcohol; Harmful Use</condition>
  <arm_group>
    <arm_group_label>CBT-I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Hygiene</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sleep hygiene handout delivered once to all participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia</intervention_name>
    <description>Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, &amp; Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.</description>
    <arm_group_label>CBT-I</arm_group_label>
    <other_name>(CBT-I)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Hygeine</intervention_name>
    <description>All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.</description>
    <arm_group_label>CBT-I</arm_group_label>
    <arm_group_label>Sleep Hygiene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Veteran deployed for military service after September 11, 2001&#xD;
&#xD;
          -  1+ heavy drinking episode (4/5+ drinks in 2 hours for women/men) in past 30 days&#xD;
&#xD;
          -  DSM-5 and research diagnostic criteria for Insomnia Disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Contraindications for CBT-I (mania or seizure disorder)&#xD;
&#xD;
          -  Untreated sleep disorder requiring more than behavioral treatment for insomnia&#xD;
&#xD;
          -  Engagement in overnight shift work at baseline&#xD;
&#xD;
          -  Care of a child under 1 year of age&#xD;
&#xD;
          -  Severe or untreated psychiatric disorder that requires immediate clinical attention&#xD;
&#xD;
          -  Current behavioral treatment for insomnia or alcohol use&#xD;
&#xD;
          -  Initiation of sleep medication in the past 6 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Missouri-Columbia</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Beth Miller, PhD</last_name>
      <phone>573-882-1813</phone>
      <email>millmary@health.missouri.edu</email>
    </contact>
    <contact_backup>
      <last_name>Nicole Hall, BA</last_name>
      <phone>573-882-8598</phone>
      <email>nahcdv@health.missouri.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Mary E Miller</investigator_full_name>
    <investigator_title>Professor, Psychiatry</investigator_title>
  </responsible_party>
  <keyword>alcohol</keyword>
  <keyword>drinking</keyword>
  <keyword>sleep</keyword>
  <keyword>insomnia</keyword>
  <keyword>veteran</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/NCT03804788
org study id: 2014239
secondary id: K23AA026895
nct id: NCT03804788
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project aims to evaluate improvement of insomnia as a mechanism of improvement in
      alcohol use outcomes.
More than half of returning Veterans who screen positive for hazardous drinking report
      clinically significant symptoms of insomnia. In turn, insomnia symptoms have been associated
      with increased risk of alcohol-related problems, perhaps due to insomnia-related impairments
      in executive functioning, negative emotionality, and craving. The proposed project aims to
      examine improvements in insomnia as a mechanism for improvement in alcohol use among
      heavy-drinking Veterans with insomnia. Forty-four returning Veterans who report heavy
      drinking (≥4/5 drinks per occasion for women/men) and have insomnia based on DSM-5 and
      research diagnostic criteria will participate in a randomized pilot trial. Participants will
      be randomly assigned to receive personalized normative alcohol feedback in the context of one
      of two treatment conditions: CBT-I (n = 22) or a sleep hygiene education control (SH; n =
      22). Outcomes will be assessed at the end of the active intervention period (6 weeks),
      mid-treatment (after 3 sessions), and at 3 months post-intervention. Outcomes of interest
      include insomnia severity, total wake time, sleep quality, drinking quantity/frequency,
      alcohol-related consequences, executive functioning, negative affect, emotion regulation,
      craving for alcohol, and use of alcohol as a sleep aid.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to receive sleep hygiene or to participate in sessions of individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: PI Miller will be blind to participant assignment because the project manager will inform study therapists of participant assignment to conditions. PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition. All participants will be told that they are receiving treatment for insomnia in order to blind them to condition assignment (sleep hygiene will be described as "brief" insomnia treatment, and CBT-I will be described as the "most intense" treatment).
measure: Recruitment
time frame: Assessed at post-treatment (weeks 7-8)
description: Number of participants who complete baseline assessment
measure: Retention
time frame: Assessed at post-treatment (weeks 7-8)
description: Number of participants who complete all treatment sessions
measure: Drinking quantity
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using Timeline Followback and Daily Drinking Questionnaire
measure: Alcohol-related consequences
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Brief Young Adult Alcohol Consequences Questionnaire
measure: Insomnia symptoms
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using Insomnia Severity Index (ISI); ISI evaluates self-reports of insomnia experiences
measure: Sleep quality
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using daily sleep diaries
measure: Sleep efficiency
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using daily sleep diaries and actigraphy
measure: Client satisfaction
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Client Satisfaction Questionnaire
measure: Working memory updating
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Keep Track task as described by Friedman et al (2008).
measure: Working memory updating
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the N-Back Task as described in Jaeggi et al (2010).
measure: Working memory updating
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Letter Memory task as described in Miyake & Friedman (2012)
measure: Response inhibition
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Stop Signal task
measure: Self-reported executive function
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Behavior Rating Inventory of Executive Function of Adults
measure: Delay discounting
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable; see Kirby, Petry, & Bickel, 1999). Higher k values indicate a greater preference for smaller, immediate rewards over larger, delayed reward.
measure: Delay discounting
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the 5-trial delay discounting task
measure: Negative affect
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Positive and Negative Affect Schedule. Participants indicate using a 1 (not at all) - 5 (extremely) scale to indicate to what extent they feel negative emotions. The final score is the sum of the ten negative emotions/feelings. Higher scores indicate more negative affect.
measure: Emotion regulation
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). The DERS-16 is a shortened version of the DERS scale. It measures emotion dysregulation based on subscales of clarity, goals, strategies, impulses, and non-acceptance.
measure: Alcohol craving
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using the Penn Alcohol Craving Scale (PACS); PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts.
measure: Use of alcohol to help with sleep
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using daily sleep diaries
measure: Use of sleep medication
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using daily sleep diaries
measure: Autonomic arousal
time frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
description: Assessed using holter monitoring devices that provide a physiological index of arousal in the autonomic nervous system.
arm group label: CBT-I
arm group type: Experimental
description: Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.
arm group label: Sleep Hygiene
arm group type: Active Comparator
description: Sleep hygiene handout delivered once to all participants.
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia
description: Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
arm group label: CBT-I
other name: (CBT-I)
intervention type: Behavioral
intervention name: Sleep Hygeine
description: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
arm group label: CBT-I
arm group label: Sleep Hygiene
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Mary E Miller
investigator title: Professor, Psychiatry
mesh term: Sleep Initiation and Maintenance Disorders