<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/NCT03806491</url>
  </required_header>
  <id_info>
    <org_study_id>2012262</org_study_id>
    <nct_id>NCT03806491</nct_id>
  </id_info>
  <brief_title>CBT-I on Alcohol Treatment Outcomes Among Veterans</brief_title>
  <acronym>Project SAVE</acronym>
  <official_title>The Impact of CBT for Insomnia on Alcohol Treatment Outcomes Among Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harry S. Truman Memorial Veterans' Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Missouri-Columbia</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>
      Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I&#xD;
      supplement to alcohol treatment of Veterans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol use disorders (AUDs) are prevalent among Veterans and result in significant physical&#xD;
      and psychological burden. Among those who receive treatment for AUDs, 1 in 3 relapses to&#xD;
      problematic drinking within one year of treatment. Thus, additional strategies are needed to&#xD;
      enhance alcohol treatment outcomes. One promising approach involves providing concurrent&#xD;
      treatment for a common complaint - difficulty falling or staying asleep. Up to 74% of&#xD;
      Veterans seeking treatment for AUD report co-occurring symptoms of insomnia. Given the&#xD;
      negative impact of insomnia on attention and emotion regulation, insomnia symptoms may&#xD;
      decrease patients' abilities to attend to alcohol treatment and manage negative emotions that&#xD;
      lead to craving and relapse. Moreover, approximately 50% of individuals with AUDs report&#xD;
      using alcohol to help them sleep, making relapse more likely for those with no other tools or&#xD;
      skills to help them sleep. Indeed, sleep disturbance has been identified as a risk factor for&#xD;
      relapse among individuals in alcohol treatment. Thus, effective treatment of sleep problems&#xD;
      may enhance alcohol treatment. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been&#xD;
      effective in reducing insomnia severity in individuals with AUDs; however, no investigations&#xD;
      have examined the efficacy of CBT-I delivered concurrently with AUD treatment to determine&#xD;
      its impact on treatment outcomes. This R21 aims to examine the feasibility, acceptability,&#xD;
      and initial efficacy of a CBT-I supplement to ongoing alcohol treatment. A randomized pilot&#xD;
      trial with 80 Veterans who meet diagnostic criteria for AUD and Insomnia Disorder will be&#xD;
      conducted. Participants will be randomly assigned to receive Cognitive Behavioral Therapy for&#xD;
      Insomnia (CBT-I) or minimal treatment (educational handout only; EDU) in addition to alcohol&#xD;
      treatment as usual. Outcomes will be assessed at the end of the active intervention period (6&#xD;
      weeks) and 6 weeks post-intervention. Preliminary process outcomes include&#xD;
      recruitment/retention rates and treatment satisfaction (feasibility and acceptability,&#xD;
      respectively). Primary outcomes are insomnia severity, percentage of heavy drinking days, and&#xD;
      alcohol-related problems; and we plan to examine post-treatment changes in insomnia severity&#xD;
      as a mediator of treatment effects on alcohol use outcomes. We will also assess treatment&#xD;
      effects on a variety of secondary clinical and mechanistic outcomes (e.g., PTSD symptoms,&#xD;
      attention, working memory, treatment-related learning). Multiple imputation will be used for&#xD;
      missing data, and analyses will be intent-to-treat.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2019</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</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>In addition to Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT-AUD), participants will be randomized to receive sleep education or to participate in 5 individual sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The project manager will inform study therapists of participant assignment to conditions. PI Miller and study therapists will be blinded to assessment outcomes, and the assessment RA will be blinded to participant condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia severity</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Insomnia Severity Index (ISI); ISI will be used as a 7-item measure of insomnia severity in the past two weeks. Items assess difficulty falling or staying asleep, satisfaction with current sleep pattern, interference with daily functioning, the extent to which others notice their sleep problems, and worry/distress related to sleep problems. Response options range from 0 (not at all worried) to 4 (very much worried), with possible total scores ranging from 0 to 28. Participants scoring 10 or higher will be classified as screening positive for insomnia (Morin et al., 2011).114 Notably, self-report is the recommended method of assessment for symptoms of insomnia in adults (Schutte-Rodin et al., 2008).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of heavy-drinking days</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow-up (week 12)</time_frame>
    <description>Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 30 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol problems</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow-up (week 12)</time_frame>
    <description>Assessed using the Short Inventory of Problems (SIP); SIP measures adverse consequences of substance use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep efficiency</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using daily sleep diaries. Sleep Diaries are quotidian questionnaires that measure self-reported sleep quality, sleep &amp; wake time, and daily habits concerning substance use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Traumatic Stress Disorder symptoms</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Post-Traumatic Stress Disorder Checklist from the Diagnostic and Statistical Manual-5 (PCL-5); PCL-5 is a 20-item measure of Post-Traumatic Stress Disorder (PTSD). On a scale of not at all (0) to extremely (4), participants indicate how frequently in the past month they were bothered by stressful experiences such as disturbing dreams, hyper-alertness, strong negative beliefs, and irritability. PCL-5 is scored by summing the responses. Possible scores range from 0-80, where higher scores indicate higher PTSD severity. Symptoms may also be gleaned into clusters of Intrusion, Avoidance, Negative alterations in cognition/mood, and Alterations in arousal/reactivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of depression</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Patient Health Questionnaire-9 (PHQ-9); PHQ-9 will be used as a 9-item measure of depressed mood and functioning that has demonstrated good sensitivity and specificity across adult samples. Participants will indicate how many days in the past two weeks (not at all, several days, more than half the days, or every day or nearly every day) they have experienced each problem. Scores will be summed and classified as minimal symptoms of depressed mood (&lt;10), moderate levels of depressed mood (10-14), high levels of depressed mood (15-19), or very high levels of depressed mood (20-27)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of anxiety</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Generalized Anxiety Disorder-7 (GAD-7); GAD-7 is a 7-item measure of anxiety with strong criterion and predictive validity. On a scale from not at all (0) to nearly every day (3), participants indicate how often in the past two weeks they have experienced problems such as having trouble relaxing and being so restless that it is hard to sit still. Possible total scores range from 0-21. Scores will be summed and classified as minimal anxiety (&lt;3), moderate anxiety (4-7), high anxiety (12-15), or severe anxiety (16-21).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-Related Learning</measure>
    <time_frame>Change from baseline to post-treatment (week 6)</time_frame>
    <description>Assessed using the Project SAVE alcohol quiz</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of alcohol to help with sleep</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the daily sleep diary; Did you use alcohol specifically to help with sleep?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol craving</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Penn Alcohol Craving Scale (PACS); The Penn Alcohol Craving Scale is a 5-item measure of alcohol craving in the past week. Participants rate the intensity, frequency, and duration of cravings, as well as their ability to resist acting on those cravings and their overall &quot;average alcohol craving&quot; for the past week. This measure has demonstrated good internal consistency and construct validity (Flannery, Volpicelli, &amp; Pettinati, 1999)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative affect</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Positive and Negative Affect Schedule (PANAS); Negative affect subscale scores range from 10-50, with higher scores indicating more extreme negative affect (measured &quot;right now&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion regulation</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Brief Difficulties in Emotion Regulation Scale (DERS-16). The 16-item Difficulties in Emotion Regulation Scale has demonstrated good convergent and discriminant validity in clinical and community samples (Bjureberg et al., 2015). On a scale from 1 (almost never) to 5 (almost always), participants will indicate how often in the past 6 weeks they would endorse items such as, &quot;I have difficulty making sense out of my feelings,&quot; and, &quot;When I am upset, I become out of control.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Psychomotor Vigilance Test (PVT); PVT measures behavioral alertness by analyzing the reaction to visual stimuli</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working memory</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the N-back task; N-Back measures the capacity for working memory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay discounting</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the Monetary Choice Questionnaire (MCQ); The MCQ (Kirby, Petry, &amp; Bickel, 1999) will be used as a self-report measure of delay discounting. In 27 trials, participants will be asked to choose between a smaller, immediate reward or a larger, delayed reward. For example, &quot;Would you prefer $54 today or $55 in 117 days?&quot; Data will be used to calculate participants' discounting-rate parameter (k).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impulsivity</measure>
    <time_frame>Change from baseline to post-treatment (week 6) to follow up (week 12)</time_frame>
    <description>Assessed using the 20-item UPPS-P Impulsive Behaviors Scale; UPPS is a 20-item measure of impulsivity and self-control. Participants indicate on a scale of not at all (0) to very (4) if statements such as &quot;I like to stop and think things over before I do them,&quot; &quot;When I am upset I often act without thinking,&quot; and &quot;I have a reserved and cautious attitude towards life&quot; are representative of him/her. Scoring is completed by summing items in the five subscales (sensation seeking, premeditation, perseverance, positive/negative urgency).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Insomnia</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>CBT-I + AUD-TAU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Hygiene + AUD-TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sleep hygiene education delivered once to all participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia</intervention_name>
    <description>Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.</description>
    <arm_group_label>CBT-I + AUD-TAU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Hygiene</intervention_name>
    <description>Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.</description>
    <arm_group_label>Sleep Hygiene + AUD-TAU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alcohol Use Disorder Treatment as Usual</intervention_name>
    <description>CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.</description>
    <arm_group_label>CBT-I + AUD-TAU</arm_group_label>
    <arm_group_label>Sleep Hygiene + AUD-TAU</arm_group_label>
    <other_name>AUD-TAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation in alcohol treatment at the Truman VA (Columbia, MO)&#xD;
&#xD;
          -  DSM-5 criteria for moderate to severe Alcohol Use Disorder&#xD;
&#xD;
          -  Substance use in the past 2 months&#xD;
&#xD;
          -  DSM-5 episodic criterion (duration at least 1 month) for Insomnia Disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  continuous sobriety for 2+ months at baseline&#xD;
&#xD;
          -  manic episode or seizure in the past year (contraindications for CBT-I)&#xD;
&#xD;
          -  severe psychiatric disorder that requires immediate clinical attention&#xD;
&#xD;
          -  initiation of a sleep medication in the past six (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>
  <overall_official>
    <last_name>Mary Beth Miller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Missouri-Columbia</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2022</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>veteran</keyword>
  <keyword>alcohol</keyword>
  <keyword>insomnia</keyword>
  <keyword>sleep</keyword>
  <keyword>drinking</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>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the research team to ensure that it meets reasonable demands of scientific integrity.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be shared after data collection is complete and results have been published (anticipated July 2022).</ipd_time_frame>
    <ipd_access_criteria>De-identified data will be made available to other qualified investigators who aim to verify data, conduct meta-analyses, or collaborate with the research team on analyses that are not already planned.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>June 7, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03806491
org study id: 2012262
nct id: NCT03806491
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I
      supplement to alcohol treatment of Veterans.
Alcohol use disorders (AUDs) are prevalent among Veterans and result in significant physical
      and psychological burden. Among those who receive treatment for AUDs, 1 in 3 relapses to
      problematic drinking within one year of treatment. Thus, additional strategies are needed to
      enhance alcohol treatment outcomes. One promising approach involves providing concurrent
      treatment for a common complaint - difficulty falling or staying asleep. Up to 74% of
      Veterans seeking treatment for AUD report co-occurring symptoms of insomnia. Given the
      negative impact of insomnia on attention and emotion regulation, insomnia symptoms may
      decrease patients' abilities to attend to alcohol treatment and manage negative emotions that
      lead to craving and relapse. Moreover, approximately 50% of individuals with AUDs report
      using alcohol to help them sleep, making relapse more likely for those with no other tools or
      skills to help them sleep. Indeed, sleep disturbance has been identified as a risk factor for
      relapse among individuals in alcohol treatment. Thus, effective treatment of sleep problems
      may enhance alcohol treatment. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been
      effective in reducing insomnia severity in individuals with AUDs; however, no investigations
      have examined the efficacy of CBT-I delivered concurrently with AUD treatment to determine
      its impact on treatment outcomes. This R21 aims to examine the feasibility, acceptability,
      and initial efficacy of a CBT-I supplement to ongoing alcohol treatment. A randomized pilot
      trial with 80 Veterans who meet diagnostic criteria for AUD and Insomnia Disorder will be
      conducted. Participants will be randomly assigned to receive Cognitive Behavioral Therapy for
      Insomnia (CBT-I) or minimal treatment (educational handout only; EDU) in addition to alcohol
      treatment as usual. Outcomes will be assessed at the end of the active intervention period (6
      weeks) and 6 weeks post-intervention. Preliminary process outcomes include
      recruitment/retention rates and treatment satisfaction (feasibility and acceptability,
      respectively). Primary outcomes are insomnia severity, percentage of heavy drinking days, and
      alcohol-related problems; and we plan to examine post-treatment changes in insomnia severity
      as a mediator of treatment effects on alcohol use outcomes. We will also assess treatment
      effects on a variety of secondary clinical and mechanistic outcomes (e.g., PTSD symptoms,
      attention, working memory, treatment-related learning). Multiple imputation will be used for
      missing data, and analyses will be intent-to-treat.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In addition to Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT-AUD), participants will be randomized to receive sleep education or to participate in 5 individual sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I).
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The project manager will inform study therapists of participant assignment to conditions. PI Miller and study therapists will be blinded to assessment outcomes, and the assessment RA will be blinded to participant condition.
measure: Insomnia severity
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Insomnia Severity Index (ISI); ISI will be used as a 7-item measure of insomnia severity in the past two weeks. Items assess difficulty falling or staying asleep, satisfaction with current sleep pattern, interference with daily functioning, the extent to which others notice their sleep problems, and worry/distress related to sleep problems. Response options range from 0 (not at all worried) to 4 (very much worried), with possible total scores ranging from 0 to 28. Participants scoring 10 or higher will be classified as screening positive for insomnia (Morin et al., 2011).114 Notably, self-report is the recommended method of assessment for symptoms of insomnia in adults (Schutte-Rodin et al., 2008).
measure: Percent of heavy-drinking days
time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
description: Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 30 days.
measure: Alcohol problems
time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
description: Assessed using the Short Inventory of Problems (SIP); SIP measures adverse consequences of substance use.
measure: Sleep efficiency
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using daily sleep diaries. Sleep Diaries are quotidian questionnaires that measure self-reported sleep quality, sleep & wake time, and daily habits concerning substance use.
measure: Post-Traumatic Stress Disorder symptoms
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Post-Traumatic Stress Disorder Checklist from the Diagnostic and Statistical Manual-5 (PCL-5); PCL-5 is a 20-item measure of Post-Traumatic Stress Disorder (PTSD). On a scale of not at all (0) to extremely (4), participants indicate how frequently in the past month they were bothered by stressful experiences such as disturbing dreams, hyper-alertness, strong negative beliefs, and irritability. PCL-5 is scored by summing the responses. Possible scores range from 0-80, where higher scores indicate higher PTSD severity. Symptoms may also be gleaned into clusters of Intrusion, Avoidance, Negative alterations in cognition/mood, and Alterations in arousal/reactivity.
measure: Symptoms of depression
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Patient Health Questionnaire-9 (PHQ-9); PHQ-9 will be used as a 9-item measure of depressed mood and functioning that has demonstrated good sensitivity and specificity across adult samples. Participants will indicate how many days in the past two weeks (not at all, several days, more than half the days, or every day or nearly every day) they have experienced each problem. Scores will be summed and classified as minimal symptoms of depressed mood (<10), moderate levels of depressed mood (10-14), high levels of depressed mood (15-19), or very high levels of depressed mood (20-27)
measure: Symptoms of anxiety
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Generalized Anxiety Disorder-7 (GAD-7); GAD-7 is a 7-item measure of anxiety with strong criterion and predictive validity. On a scale from not at all (0) to nearly every day (3), participants indicate how often in the past two weeks they have experienced problems such as having trouble relaxing and being so restless that it is hard to sit still. Possible total scores range from 0-21. Scores will be summed and classified as minimal anxiety (<3), moderate anxiety (4-7), high anxiety (12-15), or severe anxiety (16-21).
measure: Treatment-Related Learning
time frame: Change from baseline to post-treatment (week 6)
description: Assessed using the Project SAVE alcohol quiz
measure: Use of alcohol to help with sleep
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the daily sleep diary; Did you use alcohol specifically to help with sleep?
measure: Alcohol craving
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Penn Alcohol Craving Scale (PACS); The Penn Alcohol Craving Scale is a 5-item measure of alcohol craving in the past week. Participants rate the intensity, frequency, and duration of cravings, as well as their ability to resist acting on those cravings and their overall "average alcohol craving" for the past week. This measure has demonstrated good internal consistency and construct validity (Flannery, Volpicelli, & Pettinati, 1999)
measure: Negative affect
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Positive and Negative Affect Schedule (PANAS); Negative affect subscale scores range from 10-50, with higher scores indicating more extreme negative affect (measured "right now").
measure: Emotion regulation
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Brief Difficulties in Emotion Regulation Scale (DERS-16). The 16-item Difficulties in Emotion Regulation Scale has demonstrated good convergent and discriminant validity in clinical and community samples (Bjureberg et al., 2015). On a scale from 1 (almost never) to 5 (almost always), participants will indicate how often in the past 6 weeks they would endorse items such as, "I have difficulty making sense out of my feelings," and, "When I am upset, I become out of control."
measure: Attention
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Psychomotor Vigilance Test (PVT); PVT measures behavioral alertness by analyzing the reaction to visual stimuli
measure: Working memory
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the N-back task; N-Back measures the capacity for working memory
measure: Delay discounting
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the Monetary Choice Questionnaire (MCQ); The MCQ (Kirby, Petry, & Bickel, 1999) will be used as a self-report measure of delay discounting. In 27 trials, participants will be asked to choose between a smaller, immediate reward or a larger, delayed reward. For example, "Would you prefer $54 today or $55 in 117 days?" Data will be used to calculate participants' discounting-rate parameter (k).
measure: Impulsivity
time frame: Change from baseline to post-treatment (week 6) to follow up (week 12)
description: Assessed using the 20-item UPPS-P Impulsive Behaviors Scale; UPPS is a 20-item measure of impulsivity and self-control. Participants indicate on a scale of not at all (0) to very (4) if statements such as "I like to stop and think things over before I do them," "When I am upset I often act without thinking," and "I have a reserved and cautious attitude towards life" are representative of him/her. Scoring is completed by summing items in the five subscales (sensation seeking, premeditation, perseverance, positive/negative urgency).
arm group label: CBT-I + AUD-TAU
arm group type: Experimental
description: Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
arm group label: Sleep Hygiene + AUD-TAU
arm group type: Active Comparator
description: Sleep hygiene education delivered once to all participants
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia
description: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
arm group label: CBT-I + AUD-TAU
intervention type: Behavioral
intervention name: Sleep Hygiene
description: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
arm group label: Sleep Hygiene + AUD-TAU
intervention type: Behavioral
intervention name: Alcohol Use Disorder Treatment as Usual
description: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
arm group label: CBT-I + AUD-TAU
arm group label: Sleep Hygiene + AUD-TAU
other name: AUD-TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mary Beth Miller, PhD
role: Principal Investigator
affiliation: University of Missouri-Columbia
facility: 
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
mesh term: Alcoholism
sharing ipd: Yes
ipd description: After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the research team to ensure that it meets reasonable demands of scientific integrity.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Data will be shared after data collection is complete and results have been published (anticipated July 2022).
ipd access criteria: De-identified data will be made available to other qualified investigators who aim to verify data, conduct meta-analyses, or collaborate with the research team on analyses that are not already planned.
submitted: June 7, 2023