Digital CBT-I for Insomnia Disorder

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

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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