Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 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). |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Primary |
Percent of heavy-drinking days |
Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 30 days. |
Change from baseline to post-treatment (week 6) to follow-up (week 12) |
|
| Primary |
Alcohol problems |
Assessed using the Short Inventory of Problems (SIP); SIP measures adverse consequences of substance use. |
Change from baseline to post-treatment (week 6) to follow-up (week 12) |
|
| Secondary |
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. |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
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. Symptoms may also be gleaned into clusters of Intrusion, Avoidance, Negative alterations in cognition/mood, and Alterations in arousal/reactivity. |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
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 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) |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
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). |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
Treatment-Related Learning |
Assessed using the Project SAVE alcohol quiz |
Change from baseline to post-treatment (week 6) |
|
| Secondary |
Use of alcohol to help with sleep |
Assessed using the daily sleep diary; Did you use alcohol specifically to help with sleep? |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
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 (Flannery, Volpicelli, & Pettinati, 1999) |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
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"). |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
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). 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." |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
Attention |
Assessed using the Psychomotor Vigilance Test (PVT); PVT measures behavioral alertness by analyzing the reaction to visual stimuli |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
Working memory |
Assessed using the N-back task; N-Back measures the capacity for working memory |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
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). |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
|
| Secondary |
Impulsivity |
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). |
Change from baseline to post-treatment (week 6) to follow up (week 12) |
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