Alcohol Use Disorder, Heavy Drinking
Conditions
Keywords
Sleep, Cognitive Behavioral Therapy, CBT, Alcohol, App, Non Pharmacological
Brief summary
Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Insomnia is highly prevalent among individuals with AUD, and disrupted sleep contributes substantially to alcohol-related problems. While research suggests that treating insomnia may effectively reduce AUD, the degree to which treating insomnia in heavy drinkers reduces alcohol consumption and prevents the onset of severe AUD is not known. This study will be the first to evaluate an Internet-based version of cognitive behavioral therapy for insomnia (CBT-I) in community-dwelling, heavy drinking adults with insomnia. Sleep Healthy Using the Internet (SHUTi), the most widely-used and well-validated version of Internet-based CBT-I will be used. The primary aim is to reduce alcohol consumption and insomnia severity in this population.
Detailed description
The study will investigate the efficacy of Sleep Healthy Using the Internet (SHUTi), an online insomnia intervention, in reducing alcohol consumption and improving sleep in heavy drinkers with insomnia. The participants are ages 18-50 (N=100) who have insomnia and are heavy drinkers (at least weekly binge drinking episodes \[4/5+ drinks in one sitting for men/women\]). This intervention has a mixed methods randomized controlled trial design. Participants will be randomly assigned to either the online SHUTi intervention (N=50), or a patient education (PE) website (N=50). Quantitative data will be collected via online REDCap surveys and daily online diaries. Qualitative data will be collected via semi-structured telephone interviews. Data collection points will be pre-intervention, post-intervention, and 3- and 6-months postintervention.
Interventions
BEHAVIORALSHUTi Intervention
Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
BEHAVIORALWeb-Based Insomnia Education Program
Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
Sponsors
Jessica Weafer
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-50 years old * Fluency in English * At least weekly binge drinking episodes (4/5+ drinks for women/men)\] * Insomnia Severity Index (ISI) scores #15
Exclusion criteria
* No internet access * Past or current substance use disorder (other than mild or moderate AUD) * Obstructive sleep apnea * Bipolar disorder, schizophrenia, or other psychotic spectrum disorder * Pregnancy or nursing for women * Any serious medical or neurological problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change In Alcohol Use: 1) Total Number of Drinking Days (DD) | 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention) | Participants reported daily alcohol use on a daily alcohol diary, including whether alcohol was consumed each day. Daily responses were used to calculate the total number of drinking days during the assessment period. |
| Change In Alcohol Use: 2) Average Number of Drinks Per Drinking Day (DPDD). | 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention) | Participants will report the number of drinks consumed each day on a daily alcohol diary. |
| Change In Alcohol Use: 3) Total Number of Drinks (TD). | 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention) | Participants will report the number of drinks consumed each day on a daily alcohol diary. |
| Change In Alcohol Use: 4) Total Number of Binge Episodes (HDD) | 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention) | Participants will report the number of drinks consumed each day on a daily alcohol diary. Summary measures will include total number of binge episodes (4/5+ drinks for women/men) over a 10-day period. |
| Change In Sleep: Insomnia Severity Index (ISI) | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | The ISI uses a 7-item scale to asses insomnia impact over the previous two weeks. Items scores range from 0-28. Scores indicate moderate to severe insomnia. Moderate or marked clinical improvement is indicated by a change score of \>7 or \>8 respectively. Higher scores on the ISI mean worse sleep (more severe insomnia). |
| Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI) | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | The PSQI indexes one-month global sleep quality using 18 items scored on a scale from 0-21. On the PSQI, higher scores mean worse sleep quality. |
| Change In Sleep: 3) Daily Sleep Diaries | 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention) | Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep. |
| Change In Sleep: 4) Daily Sleep Diaries | 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention) | Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep. |
| Change in Medication Use: 5) Daily Sleep Diaries | 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention) | Participants will report the amount of sleep medication used each day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change In Mood: 1) Perceived Stress Scale (PSS) | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | The PSS will assess perceived stress over the prior month. Scores range from 0-40. The PSS demonstrates strong concurrent and predictive validity for various health behaviors and outcomes with higher scores indicating greater psychological distress. |
| Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10) | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | The CESD-R-10 will index past-week depressive symptoms. Scores range from 0-30. Higher scores represent more severe symptoms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Weafer, PhD
University of Kentucky
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment United States | 113 participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 52 |
| other Total, other adverse events | 0 / 61 | 0 / 52 |
| serious Total, serious adverse events | 0 / 61 | 0 / 52 |
Outcome results
None listed