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CBT-I on Alcohol Treatment Outcomes Among Veterans (Project SAVE)

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ClinicalTrials.gov Identifier: NCT03806491
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : December 6, 2021
Sponsor:
Collaborator:
Harry S. Truman Memorial Veterans' Hospital
Information provided by (Responsible Party):
Mary E Miller, University of Missouri-Columbia

Brief Summary:
Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to alcohol treatment of Veterans.

Condition or disease Intervention/treatment Phase
Insomnia Alcohol Use Disorder Behavioral: Cognitive Behavioral Therapy for Insomnia Behavioral: Sleep Hygiene Behavioral: Alcohol Use Disorder Treatment as Usual Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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).
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.
Primary Purpose: Treatment
Official Title: The Impact of CBT for Insomnia on Alcohol Treatment Outcomes Among Veterans
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep
Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: CBT-I + AUD-TAU
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Behavioral: Cognitive Behavioral Therapy for Insomnia
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.

Behavioral: Alcohol Use Disorder Treatment as Usual
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.
Other Name: AUD-TAU

Active Comparator: Sleep Hygiene + AUD-TAU
Sleep hygiene education delivered once to all participants
Behavioral: Sleep Hygiene
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.

Behavioral: Alcohol Use Disorder Treatment as Usual
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.
Other Name: AUD-TAU




Primary Outcome Measures :
  1. Insomnia severity [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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).

  2. Percent of heavy-drinking days [ Time Frame: Change from baseline to post-treatment (week 6) to follow-up (week 12) ]
    Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 30 days.

  3. Alcohol problems [ Time Frame: Change from baseline to post-treatment (week 6) to follow-up (week 12) ]
    Assessed using the Short Inventory of Problems (SIP); SIP measures adverse consequences of substance use.


Secondary Outcome Measures :
  1. Sleep efficiency [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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.

  2. Post-Traumatic Stress Disorder symptoms [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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.

  3. Symptoms of depression [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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)

  4. Symptoms of anxiety [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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).

  5. Treatment-Related Learning [ Time Frame: Change from baseline to post-treatment (week 6) ]
    Assessed using the Project SAVE alcohol quiz

  6. Use of alcohol to help with sleep [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    Assessed using the daily sleep diary; Did you use alcohol specifically to help with sleep?

  7. Alcohol craving [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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)

  8. Negative affect [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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").

  9. Emotion regulation [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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."

  10. Attention [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    Assessed using the Psychomotor Vigilance Test (PVT); PVT measures behavioral alertness by analyzing the reaction to visual stimuli

  11. Working memory [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    Assessed using the N-back task; N-Back measures the capacity for working memory

  12. Delay discounting [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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).

  13. Impulsivity [ Time Frame: Change from baseline to post-treatment (week 6) to follow up (week 12) ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participation in alcohol treatment at the Truman VA (Columbia, MO)
  • DSM-5 criteria for moderate to severe Alcohol Use Disorder
  • Substance use in the past 2 months
  • DSM-5 episodic criterion (duration at least 1 month) for Insomnia Disorder

Exclusion Criteria:

  • unable to provide informed consent
  • cognitive impairment
  • continuous sobriety for 2+ months at baseline
  • manic episode or seizure in the past year (contraindications for CBT-I)
  • severe psychiatric disorder that requires immediate clinical attention
  • initiation of a sleep medication in the past six (6) weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806491


Contacts
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Contact: Mary Beth Miller, PhD 573-882-1813 millmary@health.missouri.edu

Locations
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United States, Missouri
University of Missouri-Columbia Recruiting
Columbia, Missouri, United States, 65212
Contact: Mary Beth Miller, PhD    573-882-1813    millmary@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Harry S. Truman Memorial Veterans' Hospital
Investigators
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Principal Investigator: Mary Beth Miller, PhD University of Missouri-Columbia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mary E Miller, Professor, Psychiatry, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03806491    
Other Study ID Numbers: 2012262
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be shared after data collection is complete and results have been published (anticipated July 2022).
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary E Miller, University of Missouri-Columbia:
veteran
alcohol
insomnia
sleep
drinking
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Alcoholism
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders