Alcohol; Harmful Use, Insomnia
Conditions
Keywords
alcohol, drinking, sleep, insomnia, veteran
Brief summary
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Detailed description
More than half of returning Veterans who screen positive for hazardous drinking report clinically significant symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems, perhaps due to insomnia-related impairments in executive functioning, negative emotionality, and craving. The proposed project aims to examine improvements in insomnia as a mechanism for improvement in alcohol use among heavy-drinking Veterans with insomnia. Forty-four returning Veterans who report heavy drinking (≥4/5 drinks per occasion for women/men) and have insomnia based on DSM-5 and research diagnostic criteria will participate in a randomized pilot trial. Participants will be randomly assigned to receive personalized normative alcohol feedback in the context of one of two treatment conditions: CBT-I (n = 22) or a sleep hygiene education control (SH; n = 22). Outcomes will be assessed at the end of the active intervention period (6 weeks), mid-treatment (after 3 sessions), and at 3 months post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity/frequency, alcohol-related consequences, executive functioning, negative affect, emotion regulation, craving for alcohol, and use of alcohol as a sleep aid.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
BEHAVIORALSleep Hygeine
All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Sponsors
University of Missouri-Columbia
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
PI Miller will be blind to participant assignment because the project manager will inform study therapists of participant assignment to conditions. PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition. All participants will be told that they are receiving treatment for insomnia in order to blind them to condition assignment (sleep hygiene will be described as "brief" insomnia treatment, and CBT-I will be described as the "most intense" treatment).
Intervention model description
Subjects will be randomized to receive sleep hygiene or to participate in sessions of individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Veteran deployed for military service after September 11, 2001 * 1+ heavy drinking episode (4/5+ drinks in 2 hours for women/men) in past 30 days * DSM-5 and research diagnostic criteria for Insomnia Disorder
Exclusion criteria
* Inability to provide informed consent * Cognitive impairment * Contraindications for CBT-I (mania or seizure disorder) * Untreated sleep disorder requiring more than behavioral treatment for insomnia * Engagement in overnight shift work at baseline * Care of a child under 1 year of age * Severe or untreated psychiatric disorder that requires immediate clinical attention * Current behavioral treatment for insomnia or alcohol use * Initiation of sleep medication in the past 6 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Assessed at baseline | Number of eligible participants who enrolled in the study |
| Retention | Assessed at post-treatment (week 6) | Number of participants who complete all treatment sessions |
| Drinking Quantity | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Assessed using Daily Drinking Questionnaire. Participants report the number of standard drinks consumed on each day of a typical week in the past month (on Monday, Tuesday, Wednesday, etc). Responses for each day are then summed to calculate a total "drinks per week" variable, where higher scores indicate more standard drinks. |
| Alcohol-related Consequences | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Assessed using the Brief Young Adult Alcohol Consequences Questionnaire, which asks participants to indicate (yes/no) which of 24 consequences they have experienced in the past month. Responses range from 0 to 24, with greater scores indicating more consequences. |
| Insomnia Symptoms | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Assessed using Insomnia Severity Index (ISI). ISI scores from 0 to 28, with higher scores indicating more severe insomnia. |
| Sleep Quality | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | On daily sleep diaries, participants reported sleep quality on a scale from 0 (very poor) to 4 (very good). Higher scores indicate better sleep quality. |
| Sleep Efficiency | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Daily sleep diaries were used to calculate the amount of time that participants spent sleeping out of all the time they spent in bed. Values from 0 to 100, with higher scores indicating better sleep efficiency. The treatment goal is 85%. |
| Client Satisfaction | Mean score at post-treatment (week 6). | Assessed using the 8-item Client Satisfaction Questionnaire. Participants rate their satisfaction with insomnia treatment on a scale from 1 (poor) to 4 (excellent). Scores were summed and then divided by the number of items to create a meaningful standardized score. Higher scores indicate greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delay Discounting | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable). K values typically fall between 0.0 and 0.5, with higher values indicating a preference for smaller, immediate rewards over larger, delayed reward ("delay discounting"). |
| Negative Affect | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Assessed using the Positive and Negative Affect Schedule. Participants indicate using a 1 (not at all) - 5 (extremely) scale to indicate to what extent they feel negative emotions. The final score is the sum of the ten negative emotions/feelings. Higher scores indicate more negative affect. |
| Emotion Regulation | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). Scores range from 0 to 64, with higher scores indicating more difficulties with emotion regulation. |
| Alcohol Craving | Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Assessed using the Penn Alcohol Craving Scale (PACS). Scores range from 0 to 30, with higher scores indicating more craving. |
| Percentage of Days Using Alcohol to Help With Sleep | Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Participants completed 2 weeks of sleep diaries assessing use of alcohol to help with sleep. Number of days reporting use of alcohol as a sleep aid was divided by the number of diaries completed to indicate the percentage of diary days they used alcohol as a sleep aid. Higher scores indicate more frequent use of alcohol as a sleep aid. |
| Percentage of Days Using Sleep Medication | Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below. | Participants completed 2 weeks of sleep diaries assessing use of sleep medication. Number of days reporting use of sleep medication was divided by the number of diaries completed to indicate the percentage of diary days they used a sleep medication. Higher scores indicate more frequent use of sleep medication. |
Countries
United States
Participant flow
Recruitment details
Heavy-drinking Veterans were recruited via online digital marketing between April 2019 and August 2023.
Participants by arm
| Arm | Count |
|---|---|
| CBT-I Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician. | 38 |
| Sleep Hygiene Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician. | 33 |
| Total | 71 |
Baseline characteristics
| Characteristic | CBT-I | Total | Sleep Hygiene |
|---|---|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 7.7 | 37.7 years STANDARD_DEVIATION 9.3 | 38.3 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 68 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 58 Participants | 27 Participants |
| Region of Enrollment United States | 38 participants | 71 participants | 33 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 32 Participants | 57 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 33 |
| other Total, other adverse events | 1 / 38 | 0 / 33 |
| serious Total, serious adverse events | 0 / 38 | 0 / 33 |
Outcome results
Primary
Alcohol-related Consequences
Assessed using the Brief Young Adult Alcohol Consequences Questionnaire, which asks participants to indicate (yes/no) which of 24 consequences they have experienced in the past month. Responses range from 0 to 24, with greater scores indicating more consequences.
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Alcohol-related Consequences | Follow-up (week 20) | 3.31 number of alcohol-related consequences | Standard Deviation 4.2 |
| Eligible Participants | Alcohol-related Consequences | Baseline | 7.92 number of alcohol-related consequences | Standard Deviation 5.34 |
| Eligible Participants | Alcohol-related Consequences | Post (week 6) | 2.45 number of alcohol-related consequences | Standard Deviation 3.25 |
| Sleep Hygiene | Alcohol-related Consequences | Post (week 6) | 4.46 number of alcohol-related consequences | Standard Deviation 4.76 |
| Sleep Hygiene | Alcohol-related Consequences | Follow-up (week 20) | 5.28 number of alcohol-related consequences | Standard Deviation 4.35 |
| Sleep Hygiene | Alcohol-related Consequences | Baseline | 8.45 number of alcohol-related consequences | Standard Deviation 6.49 |
Primary
Client Satisfaction
Assessed using the 8-item Client Satisfaction Questionnaire. Participants rate their satisfaction with insomnia treatment on a scale from 1 (poor) to 4 (excellent). Scores were summed and then divided by the number of items to create a meaningful standardized score. Higher scores indicate greater satisfaction.
Time frame: Mean score at post-treatment (week 6).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Participants | Client Satisfaction | 3.59 score on a scale | Standard Deviation 0.4 |
| Sleep Hygiene | Client Satisfaction | 2.72 score on a scale | Standard Deviation 0.57 |
Primary
Drinking Quantity
Assessed using Daily Drinking Questionnaire. Participants report the number of standard drinks consumed on each day of a typical week in the past month (on Monday, Tuesday, Wednesday, etc). Responses for each day are then summed to calculate a total drinks per week variable, where higher scores indicate more standard drinks.
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Drinking Quantity | Baseline | 18.63 drinks per week | Standard Deviation 15.76 |
| Eligible Participants | Drinking Quantity | Post (week 6) | 15.29 drinks per week | Standard Deviation 14.73 |
| Eligible Participants | Drinking Quantity | Follow-up (week 20) | 15.12 drinks per week | Standard Deviation 21.96 |
| Sleep Hygiene | Drinking Quantity | Post (week 6) | 12.00 drinks per week | Standard Deviation 9.84 |
| Sleep Hygiene | Drinking Quantity | Baseline | 17.94 drinks per week | Standard Deviation 15.26 |
| Sleep Hygiene | Drinking Quantity | Follow-up (week 20) | 15.73 drinks per week | Standard Deviation 15.89 |
Primary
Insomnia Symptoms
Assessed using Insomnia Severity Index (ISI). ISI scores from 0 to 28, with higher scores indicating more severe insomnia.
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Insomnia Symptoms | Follow-up (week 20) | 6.97 score on a scale | Standard Deviation 5.84 |
| Eligible Participants | Insomnia Symptoms | Baseline | 17.29 score on a scale | Standard Deviation 4.39 |
| Eligible Participants | Insomnia Symptoms | Post (week 6) | 7.24 score on a scale | Standard Deviation 4.83 |
| Sleep Hygiene | Insomnia Symptoms | Post (week 6) | 12.27 score on a scale | Standard Deviation 4.57 |
| Sleep Hygiene | Insomnia Symptoms | Follow-up (week 20) | 12.30 score on a scale | Standard Deviation 5.14 |
| Sleep Hygiene | Insomnia Symptoms | Baseline | 16.88 score on a scale | Standard Deviation 4.15 |
Primary
Recruitment
Number of eligible participants who enrolled in the study
Time frame: Assessed at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Recruitment | 71 Participants |
Primary
Retention
Number of participants who complete all treatment sessions
Time frame: Assessed at post-treatment (week 6)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Retention | 33 Participants |
| Sleep Hygiene | Retention | 33 Participants |
Primary
Sleep Efficiency
Daily sleep diaries were used to calculate the amount of time that participants spent sleeping out of all the time they spent in bed. Values from 0 to 100, with higher scores indicating better sleep efficiency. The treatment goal is 85%.
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Sleep Efficiency | Baselin | 71.94 percentage of time asleep | Standard Deviation 11.84 |
| Eligible Participants | Sleep Efficiency | Post (week 6) | 87.89 percentage of time asleep | Standard Deviation 6.39 |
| Eligible Participants | Sleep Efficiency | Follow-up (week 20) | 87.10 percentage of time asleep | Standard Deviation 9.57 |
| Sleep Hygiene | Sleep Efficiency | Baselin | 68.82 percentage of time asleep | Standard Deviation 12.07 |
| Sleep Hygiene | Sleep Efficiency | Post (week 6) | 77.89 percentage of time asleep | Standard Deviation 8.84 |
| Sleep Hygiene | Sleep Efficiency | Follow-up (week 20) | 79.90 percentage of time asleep | Standard Deviation 10.57 |
Primary
Sleep Quality
On daily sleep diaries, participants reported sleep quality on a scale from 0 (very poor) to 4 (very good). Higher scores indicate better sleep quality.
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Sleep Quality | Baseline | 1.92 score on a scale | Standard Deviation 0.6 |
| Eligible Participants | Sleep Quality | Post (week 6) | 2.49 score on a scale | Standard Deviation 0.52 |
| Eligible Participants | Sleep Quality | Follow-up (week 20) | 2.53 score on a scale | Standard Deviation 0.63 |
| Sleep Hygiene | Sleep Quality | Follow-up (week 20) | 2.14 score on a scale | Standard Deviation 0.93 |
| Sleep Hygiene | Sleep Quality | Baseline | 1.73 score on a scale | Standard Deviation 0.65 |
| Sleep Hygiene | Sleep Quality | Post (week 6) | 2.13 score on a scale | Standard Deviation 0.87 |
Secondary
Alcohol Craving
Assessed using the Penn Alcohol Craving Scale (PACS). Scores range from 0 to 30, with higher scores indicating more craving.
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Alcohol Craving | Baseline | 9.29 score on a scale | Standard Deviation 5.63 |
| Eligible Participants | Alcohol Craving | Post (week 6) | 6.46 score on a scale | Standard Deviation 5.91 |
| Eligible Participants | Alcohol Craving | Follow-up (week 20) | 7.30 score on a scale | Standard Deviation 7.18 |
| Sleep Hygiene | Alcohol Craving | Baseline | 9.70 score on a scale | Standard Deviation 6.82 |
| Sleep Hygiene | Alcohol Craving | Post (week 6) | 7.62 score on a scale | Standard Deviation 6.74 |
| Sleep Hygiene | Alcohol Craving | Follow-up (week 20) | 7.04 score on a scale | Standard Deviation 5.96 |
Secondary
Delay Discounting
Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable). K values typically fall between 0.0 and 0.5, with higher values indicating a preference for smaller, immediate rewards over larger, delayed reward (delay discounting).
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants were lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Delay Discounting | Post (week 6) | .037 log (k) | Standard Deviation 0.062 |
| Eligible Participants | Delay Discounting | Follow-up (week 20) | .033 log (k) | Standard Deviation 0.062 |
| Eligible Participants | Delay Discounting | Baseline | .028 log (k) | Standard Deviation 0.062 |
| Sleep Hygiene | Delay Discounting | Post (week 6) | .009 log (k) | Standard Deviation 0.009 |
| Sleep Hygiene | Delay Discounting | Follow-up (week 20) | .011 log (k) | Standard Deviation 0.014 |
| Sleep Hygiene | Delay Discounting | Baseline | .022 log (k) | Standard Deviation 0.046 |
Secondary
Emotion Regulation
Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). Scores range from 0 to 64, with higher scores indicating more difficulties with emotion regulation.
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Emotion Regulation | Baseline | 34.53 score on a scale | Standard Deviation 13.22 |
| Eligible Participants | Emotion Regulation | Post (week 6) | 27.14 score on a scale | Standard Deviation 7.07 |
| Eligible Participants | Emotion Regulation | Follow-up (week 20) | 30.00 score on a scale | Standard Deviation 11.49 |
| Sleep Hygiene | Emotion Regulation | Baseline | 32.85 score on a scale | Standard Deviation 12.17 |
| Sleep Hygiene | Emotion Regulation | Post (week 6) | 35.79 score on a scale | Standard Deviation 12.54 |
| Sleep Hygiene | Emotion Regulation | Follow-up (week 20) | 34.88 score on a scale | Standard Deviation 11.79 |
Secondary
Negative Affect
Assessed using the Positive and Negative Affect Schedule. Participants indicate using a 1 (not at all) - 5 (extremely) scale to indicate to what extent they feel negative emotions. The final score is the sum of the ten negative emotions/feelings. Higher scores indicate more negative affect.
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Negative Affect | Baseline | 16.82 score on a scale | Standard Deviation 7.06 |
| Eligible Participants | Negative Affect | Post (week 6) | 14.18 score on a scale | Standard Deviation 5.19 |
| Eligible Participants | Negative Affect | Follow-up (week 20) | 15.77 score on a scale | Standard Deviation 7.55 |
| Sleep Hygiene | Negative Affect | Baseline | 16.39 score on a scale | Standard Deviation 6.82 |
| Sleep Hygiene | Negative Affect | Post (week 6) | 18.29 score on a scale | Standard Deviation 8.48 |
| Sleep Hygiene | Negative Affect | Follow-up (week 20) | 16.48 score on a scale | Standard Deviation 5.67 |
Secondary
Percentage of Days Using Alcohol to Help With Sleep
Participants completed 2 weeks of sleep diaries assessing use of alcohol to help with sleep. Number of days reporting use of alcohol as a sleep aid was divided by the number of diaries completed to indicate the percentage of diary days they used alcohol as a sleep aid. Higher scores indicate more frequent use of alcohol as a sleep aid.
Time frame: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Percentage of Days Using Alcohol to Help With Sleep | Post (week 6) | 3.22 % of diary days using alcohol for sleep | Standard Deviation 8.6 |
| Eligible Participants | Percentage of Days Using Alcohol to Help With Sleep | Follow-up (week 20) | 2.24 % of diary days using alcohol for sleep | Standard Deviation 4.88 |
| Eligible Participants | Percentage of Days Using Alcohol to Help With Sleep | Baseline | 16.71 % of diary days using alcohol for sleep | Standard Deviation 27.86 |
| Sleep Hygiene | Percentage of Days Using Alcohol to Help With Sleep | Post (week 6) | 6.89 % of diary days using alcohol for sleep | Standard Deviation 22.94 |
| Sleep Hygiene | Percentage of Days Using Alcohol to Help With Sleep | Follow-up (week 20) | 9.12 % of diary days using alcohol for sleep | Standard Deviation 26.17 |
| Sleep Hygiene | Percentage of Days Using Alcohol to Help With Sleep | Baseline | 6.73 % of diary days using alcohol for sleep | Standard Deviation 16.56 |
Secondary
Percentage of Days Using Sleep Medication
Participants completed 2 weeks of sleep diaries assessing use of sleep medication. Number of days reporting use of sleep medication was divided by the number of diaries completed to indicate the percentage of diary days they used a sleep medication. Higher scores indicate more frequent use of sleep medication.
Time frame: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Population: Some participants lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Percentage of Days Using Sleep Medication | Baseline | 30.92 % of diary days using a sleep medication | Standard Deviation 36.23 |
| Eligible Participants | Percentage of Days Using Sleep Medication | Post (week 6) | 14.04 % of diary days using a sleep medication | Standard Deviation 30.71 |
| Eligible Participants | Percentage of Days Using Sleep Medication | Follow-up (week 20) | 11.55 % of diary days using a sleep medication | Standard Deviation 28.18 |
| Sleep Hygiene | Percentage of Days Using Sleep Medication | Baseline | 23.15 % of diary days using a sleep medication | Standard Deviation 35.49 |
| Sleep Hygiene | Percentage of Days Using Sleep Medication | Post (week 6) | 28.44 % of diary days using a sleep medication | Standard Deviation 41.56 |
| Sleep Hygiene | Percentage of Days Using Sleep Medication | Follow-up (week 20) | 20.36 % of diary days using a sleep medication | Standard Deviation 38.35 |