Summary

Eligibility
for people ages 22 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Aric Prather, PhD
Headshot of Aric Prather
Aric Prather

Description

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.

Official Title

Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial

Details

This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.

Keywords

Insomnia Disorder Insomnia digital CBT CBT-I Sleep Initiation and Maintenance Disorders digital CBT-I Sleep hygiene education

Eligibility

You can join if…

Open to people ages 22 years and up

  • Age ≥22 years old
  • Insomnia Disorder diagnosis Score ≤16 on the 8-item Sleep Condition Indicator
  • > 30 minutes sleep onset latency (SOL); and/or > 30 minutes wake after sleep onset (WASO)
  • Current resident of the USA
  • Oral and written fluency in English
  • Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form

You CAN'T join if...

  • Must not be currently receiving or be expecting to start CBT for insomnia during study participation, or have previously received CBT for insomnia in the past 12-months (self-report)
  • If on psychoactive medication, including sleep medication, this must be stable for at least 5 half lives
  • Past or present psychosis, schizophrenia, bipolar disorder, assessed by self-report and/or seizure disorder
  • Occupation that requires alertness / caution to avoid accidents, for example long-haul driving, long distance bus driver, heavy machinery operator, air traffic controller
  • Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT-I or SHE in the opinion of the investigator
  • Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
  • Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Aric Prather, PhD
    Associate Professor, Psychiatry, School of Medicine. Authored (or co-authored) 99 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Big Health Inc.
ID
NCT05541055
Study Type
Interventional
Participants
Expecting 332 study participants
Last Updated