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Feasibility and acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I for Alcoholism

N/A
Waitlist Available
Led By Gwenyth R Wallen, Ph.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are 18 65 years old
A score of 10 or higher on the Insomnia Severity Index*
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-7 months post discharge from inpatient admission for this study
Awards & highlights

Study Summary

This trial is testing a web-based insomnia therapy program for people with alcohol use disorders to see if it works well and helps people.

Eligible Conditions
  • Alcoholism
  • Insomnia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-7 months post discharge from inpatient admission for this study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-7 months post discharge from inpatient admission for this study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Login Counts
Average Number of Sessions Completed
Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks
+51 more
Secondary outcome measures
Actigraphy-generated measures
TLFB and PACS
sleep disturbance, daytime sleepiness, anxiety/depression, fatigue, self-efficacy for sleep, dysfunctional beliefs about sleep, and functional outcomes

Trial Design

1Treatment groups
Experimental Treatment
Group I: Feasibility and acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-IExperimental Treatment1 Intervention
Individuals with alcohol use disorder (AUD) in recovery with insomnia completed six online classes that include interactive educational content and case studies about insomnia and its precipitating factors. These sessions are designed to parallel traditional (in-person) cognitive behavioral therapy for insomnia (CBT-I) sessions and are tracked and customized. New sessions are available seven days after completion of the previous session. The program includes a variety of interactive features, including goal setting, feedback based on user-identified symptoms, animations, quizzes, vignettes, and video-based expert explanations. Participants have maximum of 9-11 weeks to complete the six sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Healthy Using the Internet (SHUTi)
2008
N/A
~190

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
1,992 Previous Clinical Trials
42,875,326 Total Patients Enrolled
26 Trials studying Alcoholism
3,616 Patients Enrolled for Alcoholism
University of VirginiaOTHER
748 Previous Clinical Trials
1,235,969 Total Patients Enrolled
7 Trials studying Alcoholism
26,582 Patients Enrolled for Alcoholism
National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
988,957 Total Patients Enrolled
3 Trials studying Alcoholism
277 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Mar 2025