Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Big Health Inc.
- Enrollment
- 336
- Locations
- 2
- Primary Endpoint
- Change in the Insomnia Severity Index (ISI)
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in the Insomnia Severity Index (ISI)
Time Frame: From baseline to 10 weeks post-randomization
Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Change in sleep onset latency (SOL)
Time Frame: From baseline to 10 weeks post-randomization
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Change in wake after sleep onset (WASO)
Time Frame: From baseline to 10 weeks post-randomization
Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Secondary Outcomes
- Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI(10, 16, and 24 weeks post-randomization)
- Insomnia disorder remission based on the SCID Insomnia Module(Week -1 compared to weeks 10, 16, and 24 post-randomization)
- Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)(From lead-in period to 10, 16, and 24 weeks post-randomization)
- Change in the Sleep Condition Indicator (SCI-8)(From baseline to weeks 10, 16, and 24 post-randomization)
- Change in the Insomnia Severity Index (ISI)(From baseline to weeks 16 and 24 post-randomization)
- Change in sleep onset latency (SOL)(From baseline to weeks 16 and 24 post-randomization)
- Change in the Patient Health Questionnaire (PHQ-8)(From baseline to weeks 10, 16 and 24 post-randomization)
- Change in wake after sleep onset (WASO)(From baseline to weeks 16 and 24 post-randomization)
- Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)(From baseline to weeks 10, 16, and 24 post-randomization)