Digital CBT-I for Insomnia Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Insomnia Disorder+1 More
digital CBT-I - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.

Eligible Conditions

  • Insomnia Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Insomnia Disorder

Study Objectives

0 Primary · 9 Secondary · Reporting Duration: Week -1 compared to weeks 10, 16, and 24 post-randomization

Week 24
Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI
Week 10
Change in the Patient Health Questionnaire (PHQ-8)
Week 10
Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)
Change in the Sleep Condition Indicator (SCI-8)
Week 16
Change in sleep onset latency (SOL)
Change in the Insomnia Severity Index (ISI)
Change in wake after sleep onset (WASO)
Week 24
Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)
Week 10
Insomnia disorder remission based on the SCID Insomnia Module

Trial Safety

Safety Progress

1 of 3

Other trials for Insomnia Disorder

Trial Design

2 Treatment Groups

Sleep hygiene education
1 of 2
Digital CBT-I
1 of 2
Active Control
Experimental Treatment

332 Total Participants · 2 Treatment Groups

Primary Treatment: Digital CBT-I · No Placebo Group · N/A

Digital CBT-I
Device
Experimental Group · 1 Intervention: digital CBT-I · Intervention Types: Device
Sleep hygiene education
Other
ActiveComparator Group · 1 Intervention: Sleep hygiene education · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week -1 compared to weeks 10, 16, and 24 post-randomization
Closest Location: University of California, San Francisco · San Francisco, CA
Photo of San Francisco  1Photo of San Francisco  2Photo of San Francisco  3
2008First Recorded Clinical Trial
1 TrialsResearching Insomnia Disorder
688 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a current resident of the USA.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.