Digital CBT-I for Insomnia Disorder (CrEDIT)

Big Health

Status

Completed

Conditions

Insomnia Disorder

Treatments

Device: digital CBT-I

Other: Sleep hygiene education

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05541055

BH-S-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

336 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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