Clinical trial NCT05541055: Digital CBT-I for Insomnia Disorder
Official title: Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Disorder
Keywords: Insomnia
digital CBT
CBT-I
Lead sponsor: Big Health Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2022-09-15
Enrollment: 336
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: From baseline to 10 weeks post-randomization
measure: Change in sleep onset latency (SOL)
timeFrame: From baseline to 10 weeks post-randomization
measure: Change in wake after sleep onset (WASO)
timeFrame: From baseline to 10 weeks post-randomization
Secondary outcomes:
measure: Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI
timeFrame: 10, 16, and 24 weeks post-randomization
measure: Insomnia disorder remission based on the SCID Insomnia Module
timeFrame: Week -1 compared to weeks 10, 16, and 24 post-randomization
measure: Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)
timeFrame: From lead-in period to 10, 16, and 24 weeks post-randomization
measure: Change in the Sleep Condition Indicator (SCI-8)
timeFrame: From baseline to weeks 10, 16, and 24 post-randomization
measure: Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: From baseline to weeks 10, 16, and 24 post-randomization
measure: Change in the Patient Health Questionnaire (PHQ-8)
timeFrame: From baseline to weeks 10, 16 and 24 post-randomization
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: From baseline to weeks 16 and 24 post-randomization
measure: Change in sleep onset latency (SOL)
timeFrame: From baseline to weeks 16 and 24 post-randomization
measure: Change in wake after sleep onset (WASO)
timeFrame: From baseline to weeks 16 and 24 post-randomization
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References: