Alcohol Use DisorderNCT04564807
Testing an Online Insomnia Intervention
A study testing Web-Based Insomnia Education Program and SHUTi Intervention in people with Alcohol Use Disorder and Insomnia, run by Jessica Weafer at 1 site in United States.
Trial summary
The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Insomnia
- What is being tested?
- Web-Based Insomnia Education Program and SHUTi Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- engage in weekly alcohol binge episodes
- moderate to severe insomnia
Who cannot join
- history of severe alcohol or other substance use disorder
- obstructive sleep apnea
- schizophrenia
- bipolar disorder
- psychotic spectrum disorder
- lack of internet access
- lack of English fluency
- pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Kentucky Psychology Research Lab
Lexington, Kentucky, 40504
About this study
The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.
- Conditions
- Alcohol Use Disorder, Insomnia
- Being tested
- Web-Based Insomnia Education Program, SHUTi Intervention
- Keywords
- sleep, cognitive behavioral therapy, CBT, electronic, alcohol, non-pharmacological
- Medical subject headings
- Alcoholism, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Insomnia Education ProgramBehavioural
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.
SHUTi InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Insomnia Education Program | Active comparator | Adult heavy drinkers with insomnia. Receives: Behavioral: Web-Based Insomnia Education Program |
| SHUTi Intervention | Experimental | Adult heavy drinkers with insomnia. Receives: Behavioral: SHUTi Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use
Alcohol use will be measured using the Timeline Follow Back (TLFB) calendar. Participants will report their drinking over the past 30 days.
Measured: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Change in Insomnia
Insomnia will be measured using the Insomnia Severity Index (ISI). This survey has 7 questions related to insomnia. Scores range from 0-28, with higher scores indicating increased insomnia.
Measured: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Change in Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). It measures seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Scores range from 0-indefinite. A score greater than 5 is indicative of poor sleep quality.
Measured: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start25 Sep 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessica Weafer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jessica Weafer, University of Kentucky
- Investigators
- Jessica Weafer, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564807
- Sponsor's protocol ID
- 60446
- Other IDs
- 1013179870
- Status last verified
- Oct 2022
- First submitted
- 22 Sep 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Online Insomnia Intervention
- ClinicalTrials.gov ID
- NCT04564807
- Acronym / sponsor ID
- 60446
- Conditions
- Alcohol Use Disorder, Insomnia
- Keywords
- sleep, cognitive behavioral therapy, CBT, electronic, alcohol, non-pharmacological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Jessica WeaferUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-Based Insomnia Education Program | Active comparator | Behavioral: Web-Based Insomnia Education ProgramAdult heavy drinkers with insomnia. |
| SHUTi Intervention | Experimental | Behavioral: SHUTi InterventionAdult heavy drinkers with insomnia. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- engage in weekly alcohol binge episodes
- moderate to severe insomnia
Key exclusion criteria (8 listed)
- history of severe alcohol or other substance use disorder
- obstructive sleep apnea
- schizophrenia
- bipolar disorder
- psychotic spectrum disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Insomnia Education ProgramParticipants 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. | Behavioural | Web-Based Insomnia Education Program |
| SHUTi InterventionSleep 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. | Behavioural | SHUTi Intervention |
Primary outcome
Change in Alcohol Use
Time frame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Alcohol use will be measured using the Timeline Follow Back (TLFB) calendar. Participants will report their drinking over the past 30 days.
Change in Insomnia
Time frame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Insomnia will be measured using the Insomnia Severity Index (ISI). This survey has 7 questions related to insomnia. Scores range from 0-28, with higher scores indicating increased insomnia.
Change in Sleep Quality
Time frame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). It measures seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Scores range from 0-indefinite. A score greater than 5 is indicative of poor sleep quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Weafer, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Insomnia Education Program and SHUTi Intervention in people with Alcohol Use Disorder and Insomnia, run by Jessica Weafer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Use (time frame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.