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Online Insomnia Intervention to Reduce Alcohol Use

Primary Purpose

Alcohol Use Disorder, Heavy Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHUTi Intervention
Web-Based Insomnia Education Program
Sponsored by
Jessica Weafer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Sleep, Cognitive Behavioral Therapy, CBT, Alcohol, App, Non Pharmacological

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Of Kentucky Psychology Research LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SHUTi Intervention

Web-Based Insomnia Education Program

Arm Description

Adult heavy drinkers with insomnia

Adult heavy drinkers with insomnia

Outcomes

Primary Outcome Measures

Change In Alcohol Use: Daily Alcohol Diaries
Participants will report the number of drinks consumed each day and proximity of alcoholic drinks to bedtime. Summary measures will include total number of drinking days, total number of drinks, average number of drinks per drinking day, and total number of binge episodes (4/5+ drinks for women/men) over a 10-day period.
Change In Sleep: Insomnia Severity Index (ISI)
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.
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
The PSQI indexes one-month global sleep quality using 18 items scored on a scale from 0-21. Scores # 5 indicate poor sleep quality.
Change In Sleep: 3) Daily Sleep Diaries
Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep.
Change In Sleep: 4) Daily Sleep Diaries
Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep.
Change in Medication Use: 5) Daily Sleep Diaries
Participants will report the amount of sleep medication used each day.

Secondary Outcome Measures

Change In Mood: 1) Perceived Stress Scale (PSS)
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)
The CESD-R-10 will index past-week depressive symptoms. Scores range from 0-30. Higher scores represent more severe symptoms.

Full Information

First Posted
November 17, 2022
Last Updated
August 23, 2023
Sponsor
Jessica Weafer
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05630118
Brief Title
Online Insomnia Intervention to Reduce Alcohol Use
Official Title
Testing an Online Insomnia Intervention to Reduce Alcohol Use Via Improved Sleep Among Heavy Drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jessica Weafer
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Heavy Drinking
Keywords
Sleep, Cognitive Behavioral Therapy, CBT, Alcohol, App, Non Pharmacological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHUTi Intervention
Arm Type
Experimental
Arm Description
Adult heavy drinkers with insomnia
Arm Title
Web-Based Insomnia Education Program
Arm Type
Active Comparator
Arm Description
Adult heavy drinkers with insomnia
Intervention Type
Behavioral
Intervention Name(s)
SHUTi Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web-Based Insomnia Education Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change In Alcohol Use: Daily Alcohol Diaries
Description
Participants will report the number of drinks consumed each day and proximity of alcoholic drinks to bedtime. Summary measures will include total number of drinking days, total number of drinks, average number of drinks per drinking day, and total number of binge episodes (4/5+ drinks for women/men) over a 10-day period.
Time Frame
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Title
Change In Sleep: Insomnia Severity Index (ISI)
Description
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.
Time Frame
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Title
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI indexes one-month global sleep quality using 18 items scored on a scale from 0-21. Scores # 5 indicate poor sleep quality.
Time Frame
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Title
Change In Sleep: 3) Daily Sleep Diaries
Description
Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep.
Time Frame
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Title
Change In Sleep: 4) Daily Sleep Diaries
Description
Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep.
Time Frame
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Title
Change in Medication Use: 5) Daily Sleep Diaries
Description
Participants will report the amount of sleep medication used each day.
Time Frame
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Secondary Outcome Measure Information:
Title
Change In Mood: 1) Perceived Stress Scale (PSS)
Description
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.
Time Frame
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Title
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)
Description
The CESD-R-10 will index past-week depressive symptoms. Scores range from 0-30. Higher scores represent more severe symptoms.
Time Frame
33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
859-257-5794
Email
psychresearch@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Weafer, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Kentucky Psychology Research Lab
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-257-5794
Email
psychresearch@uky.edu
First Name & Middle Initial & Last Name & Degree
Jessica Weafer, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Online Insomnia Intervention to Reduce Alcohol Use

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