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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
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.
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.
University of Missouri-Columbia
Columbia, Missouri, United States
Insomnia Severity
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 for each item range from 0 (not at all worried) to 4 (very much worried). Individual item scores are summed to a total score - the highest possible score being 28. Higher scores indicate more severe insomnia. Participants scoring 10 or higher will be classified as screening positive for insomnia.
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Percent of Heavy-drinking Days
Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 30 days.
Time frame: Baseline to post-treatment (week 6) to follow-up (week 12)
Alcohol Problems
Assessed using the Short Inventory of Problems (SIP). SIP measures adverse consequences of substance use. Scores range 0 to 45, where higher scores indicate more frequent problems.
Time frame: Baseline to post-treatment (week 6) to follow-up (week 12)
Sleep Efficiency
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. Scores range 0 to 100, where higher scores indicate better (more favorable) sleep efficiency. Treatment goal is 85%.
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Post-Traumatic Stress Disorder Symptoms
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.
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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.
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Symptoms of Depression
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 range from 0 to 27, where higher scores indicate more severe symptoms of depression.
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Symptoms of Anxiety
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).
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Treatment-Related Learning
Assessed using the Project SAVE alcohol quiz
Time frame: Change from baseline to post-treatment (week 6)
Percentage of Days Where Alcohol Was Used to Help With Sleep
Assessed using the daily sleep diary; Did you use alcohol specifically to help with sleep?
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Alcohol Craving
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. Scores range 0 to 30, where higher scores indicate stronger craving.
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Negative Affect
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").
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Emotion Regulation
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). Scores range from 16 to 80, with higher scores indicating more difficulties with emotion regulation.
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Delay Discounting
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).
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)