Alcohol Use Disorder, Insomnia
Conditions
Keywords
veteran, alcohol, insomnia, sleep, drinking
Brief summary
Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to alcohol treatment of Veterans.
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALSleep 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.
BEHAVIORALAlcohol 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.
Sponsors
Harry S. Truman Memorial Veterans' Hospital
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity | 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 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. |
| Percent of Heavy-drinking Days | 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. |
| Alcohol Problems | 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. Scores range 0 to 45, where higher scores indicate more frequent problems. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Anxiety | 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). |
| Treatment-Related Learning | Change from baseline to post-treatment (week 6) | Assessed using the Project SAVE alcohol quiz |
| Percentage of Days Where Alcohol Was Used to Help With Sleep | 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? |
| Sleep Efficiency | 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. Scores range 0 to 100, where higher scores indicate better (more favorable) sleep efficiency. Treatment goal is 85%. |
| Negative Affect | 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). |
| Emotion Regulation | 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). Scores range from 16 to 80, with higher scores indicating more difficulties with emotion regulation. |
| Delay Discounting | 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). |
| Alcohol Craving | 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. Scores range 0 to 30, where higher scores indicate stronger craving. |
| Post-Traumatic Stress Disorder Symptoms | 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 of Depression | 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 range from 0 to 27, where higher scores indicate more severe symptoms of depression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT-I + AUD-TAU Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
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.
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. | 32 |
| Sleep Hygiene + AUD-TAU Sleep hygiene education delivered once to all participants
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.
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. | 35 |
| Total | 67 |
Baseline characteristics
| Characteristic | CBT-I + AUD-TAU | Sleep Hygiene + AUD-TAU | Total |
|---|---|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 11.9 | 46.9 years STANDARD_DEVIATION 11.9 | 46.3 years STANDARD_DEVIATION 11.8 |
| Branch Air Force | 4 Participants | 3 Participants | 7 Participants |
| Branch Army | 22 Participants | 21 Participants | 43 Participants |
| Branch Marines | 2 Participants | 5 Participants | 7 Participants |
| Branch Navy | 4 Participants | 6 Participants | 10 Participants |
| Highest level of education College graduate | 9 Participants | 10 Participants | 19 Participants |
| Highest level of education High school graduate or GED | 6 Participants | 7 Participants | 13 Participants |
| Highest level of education Some college | 16 Participants | 18 Participants | 34 Participants |
| Highest level of education Some high school | 1 Participants | 0 Participants | 1 Participants |
| Housing My own house/apt | 20 Participants | 16 Participants | 36 Participants |
| Housing On the street | 0 Participants | 3 Participants | 3 Participants |
| Housing Someone else's house/apt | 7 Participants | 5 Participants | 12 Participants |
| Housing Transitional/institutional housing | 5 Participants | 11 Participants | 16 Participants |
| Marital status Divorced, separated, widowed | 15 Participants | 23 Participants | 38 Participants |
| Marital status Married or living with partner | 11 Participants | 8 Participants | 19 Participants |
| Marital status Never married | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black or African American | 1 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic or Latinx | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Multiracial or multiethnic | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/ethnicity White only | 26 Participants | 30 Participants | 56 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 29 Participants | 32 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 35 |
| other Total, other adverse events | 0 / 32 | 0 / 35 |
| serious Total, serious adverse events | 0 / 32 | 0 / 35 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Alcohol Problems | Baseline | 25.44 score on a scale | Standard Deviation 10.11 |
| CBT-I + AUD-TAU | Alcohol Problems | 6 weeks | 4.42 score on a scale | Standard Deviation 6.19 |
| CBT-I + AUD-TAU | Alcohol Problems | 12 weeks | 4.38 score on a scale | Standard Deviation 7.65 |
| Sleep Hygiene + AUD-TAU | Alcohol Problems | Baseline | 22.00 score on a scale | Standard Deviation 12.17 |
| Sleep Hygiene + AUD-TAU | Alcohol Problems | 6 weeks | 5.12 score on a scale | Standard Deviation 9.1 |
| Sleep Hygiene + AUD-TAU | Alcohol Problems | 12 weeks | 7.00 score on a scale | Standard Deviation 9.03 |
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 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Insomnia Severity | Baseline | 17.97 score on a scale | Standard Deviation 4.66 |
| CBT-I + AUD-TAU | Insomnia Severity | 6 weeks | 5.69 score on a scale | Standard Deviation 4.7 |
| CBT-I + AUD-TAU | Insomnia Severity | 12 weeks | 8.07 score on a scale | Standard Deviation 7.13 |
| Sleep Hygiene + AUD-TAU | Insomnia Severity | Baseline | 19.26 score on a scale | Standard Deviation 4.01 |
| Sleep Hygiene + AUD-TAU | Insomnia Severity | 6 weeks | 10.96 score on a scale | Standard Deviation 6.43 |
| Sleep Hygiene + AUD-TAU | Insomnia Severity | 12 weeks | 12.42 score on a scale | Standard Deviation 6.34 |
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.
Time frame: Baseline to post-treatment (week 6) to follow-up (week 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Percent of Heavy-drinking Days | Baseline | 16.97 percentage of heavy drinking days | Standard Deviation 9.58 |
| CBT-I + AUD-TAU | Percent of Heavy-drinking Days | 6 weeks | 2.07 percentage of heavy drinking days | Standard Deviation 5.26 |
| CBT-I + AUD-TAU | Percent of Heavy-drinking Days | 12 weeks | 5.92 percentage of heavy drinking days | Standard Deviation 11.45 |
| Sleep Hygiene + AUD-TAU | Percent of Heavy-drinking Days | 6 weeks | 1.34 percentage of heavy drinking days | Standard Deviation 4.49 |
| Sleep Hygiene + AUD-TAU | Percent of Heavy-drinking Days | Baseline | 17.14 percentage of heavy drinking days | Standard Deviation 11.74 |
| Sleep Hygiene + AUD-TAU | Percent of Heavy-drinking Days | 12 weeks | 6.57 percentage of heavy drinking days | Standard Deviation 13.56 |
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. Scores range 0 to 30, where higher scores indicate stronger craving.
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Alcohol Craving | Baseline | 11.44 score on a scale | Standard Deviation 8.85 |
| CBT-I + AUD-TAU | Alcohol Craving | 6 weeks | 7.88 score on a scale | Standard Deviation 6.73 |
| CBT-I + AUD-TAU | Alcohol Craving | 12 weeks | 9.31 score on a scale | Standard Deviation 7.25 |
| Sleep Hygiene + AUD-TAU | Alcohol Craving | Baseline | 10.76 score on a scale | Standard Deviation 7.59 |
| Sleep Hygiene + AUD-TAU | Alcohol Craving | 6 weeks | 7.15 score on a scale | Standard Deviation 6.25 |
| Sleep Hygiene + AUD-TAU | Alcohol Craving | 12 weeks | 9.21 score on a scale | Standard Deviation 6.86 |
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).
Time frame: 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). 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)
Population: Some participants lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Emotion Regulation | Baseline | 20.0 score on a scale | Standard Deviation 8.7 |
| CBT-I + AUD-TAU | Emotion Regulation | 6 weeks | 15.2 score on a scale | Standard Deviation 4.5 |
| CBT-I + AUD-TAU | Emotion Regulation | 12 weeks | 18.2 score on a scale | Standard Deviation 7.8 |
| Sleep Hygiene + AUD-TAU | Emotion Regulation | Baseline | 20.3 score on a scale | Standard Deviation 9 |
| Sleep Hygiene + AUD-TAU | Emotion Regulation | 6 weeks | 18.2 score on a scale | Standard Deviation 7.8 |
| Sleep Hygiene + AUD-TAU | Emotion Regulation | 12 weeks | 20.0 score on a scale | Standard Deviation 10.6 |
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).
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Population: Some participants lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Negative Affect | Baseline | 20.0 score on a scale | Standard Deviation 8.7 |
| CBT-I + AUD-TAU | Negative Affect | 6 weeks | 15.2 score on a scale | Standard Deviation 4.5 |
| CBT-I + AUD-TAU | Negative Affect | 12 weeks | 18.2 score on a scale | Standard Deviation 7.8 |
| Sleep Hygiene + AUD-TAU | Negative Affect | Baseline | 20.3 score on a scale | Standard Deviation 9 |
| Sleep Hygiene + AUD-TAU | Negative Affect | 6 weeks | 16.5 score on a scale | Standard Deviation 7.5 |
| Sleep Hygiene + AUD-TAU | Negative Affect | 12 weeks | 20.0 score on a scale | Standard Deviation 10.6 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Percentage of Days Where Alcohol Was Used to Help With Sleep | Baseline | 3.68 percentage of days | Standard Deviation 16.86 |
| CBT-I + AUD-TAU | Percentage of Days Where Alcohol Was Used to Help With Sleep | 6 weeks | 4.08 percentage of days | Standard Deviation 15.48 |
| CBT-I + AUD-TAU | Percentage of Days Where Alcohol Was Used to Help With Sleep | 12 weeks | 8.09 percentage of days | Standard Deviation 18.55 |
| Sleep Hygiene + AUD-TAU | Percentage of Days Where Alcohol Was Used to Help With Sleep | Baseline | 2.94 percentage of days | Standard Deviation 14.83 |
| Sleep Hygiene + AUD-TAU | Percentage of Days Where Alcohol Was Used to Help With Sleep | 6 weeks | 4.76 percentage of days | Standard Deviation 21.82 |
| Sleep Hygiene + AUD-TAU | Percentage of Days Where Alcohol Was Used to Help With Sleep | 12 weeks | 3.16 percentage of days | Standard Deviation 8.44 |
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.
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Post-Traumatic Stress Disorder Symptoms | Baseline | 34.3 score on a scale | Standard Deviation 22.3 |
| CBT-I + AUD-TAU | Post-Traumatic Stress Disorder Symptoms | 6 weeks | 20.1 score on a scale | Standard Deviation 21.1 |
| CBT-I + AUD-TAU | Post-Traumatic Stress Disorder Symptoms | 12 weeks | 21.0 score on a scale | Standard Deviation 22.1 |
| Sleep Hygiene + AUD-TAU | Post-Traumatic Stress Disorder Symptoms | Baseline | 32.0 score on a scale | Standard Deviation 21.6 |
| Sleep Hygiene + AUD-TAU | Post-Traumatic Stress Disorder Symptoms | 6 weeks | 25.2 score on a scale | Standard Deviation 22.1 |
| Sleep Hygiene + AUD-TAU | Post-Traumatic Stress Disorder Symptoms | 12 weeks | 28.2 score on a scale | Standard Deviation 24.8 |
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. 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Sleep Efficiency | Baseline | 68.47 percentage | Standard Deviation 11.91 |
| CBT-I + AUD-TAU | Sleep Efficiency | 6 weeks | 87.30 percentage | Standard Deviation 7.5 |
| CBT-I + AUD-TAU | Sleep Efficiency | 12 weeks | 90.62 percentage | Standard Deviation 5.26 |
| Sleep Hygiene + AUD-TAU | Sleep Efficiency | Baseline | 71.44 percentage | Standard Deviation 13.32 |
| Sleep Hygiene + AUD-TAU | Sleep Efficiency | 6 weeks | 82.41 percentage | Standard Deviation 11.51 |
| Sleep Hygiene + AUD-TAU | Sleep Efficiency | 12 weeks | 75.31 percentage | Standard Deviation 14.11 |
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).
Time frame: Baseline to post-treatment (week 6) to follow up (week 12)
Population: Some participants lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Symptoms of Anxiety | Baseline | 9.8 score on a scale | Standard Deviation 10.8 |
| CBT-I + AUD-TAU | Symptoms of Anxiety | 6 weeks | 4.9 score on a scale | Standard Deviation 4.3 |
| CBT-I + AUD-TAU | Symptoms of Anxiety | 12 weeks | 7.2 score on a scale | Standard Deviation 6.6 |
| Sleep Hygiene + AUD-TAU | Symptoms of Anxiety | Baseline | 10.8 score on a scale | Standard Deviation 5.8 |
| Sleep Hygiene + AUD-TAU | Symptoms of Anxiety | 6 weeks | 7.0 score on a scale | Standard Deviation 5.7 |
| Sleep Hygiene + AUD-TAU | Symptoms of Anxiety | 12 weeks | 8.7 score on a scale | Standard Deviation 5.6 |
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 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)
Population: Some participants lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I + AUD-TAU | Symptoms of Depression | Baseline | 10.9 score on a scale | Standard Deviation 5.6 |
| CBT-I + AUD-TAU | Symptoms of Depression | 6 weeks | 4.7 score on a scale | Standard Deviation 4.7 |
| CBT-I + AUD-TAU | Symptoms of Depression | 12 weeks | 7.3 score on a scale | Standard Deviation 6 |
| Sleep Hygiene + AUD-TAU | Symptoms of Depression | Baseline | 12.3 score on a scale | Standard Deviation 5.6 |
| Sleep Hygiene + AUD-TAU | Symptoms of Depression | 6 weeks | 7.4 score on a scale | Standard Deviation 6.3 |
| Sleep Hygiene + AUD-TAU | Symptoms of Depression | 12 weeks | 8.9 score on a scale | Standard Deviation 7.5 |
Secondary
Treatment-Related Learning
Assessed using the Project SAVE alcohol quiz
Time frame: Change from baseline to post-treatment (week 6)