Digital CBT-I for Insomnia Disorder

Not Applicable

Completed

Conditions: Insomnia Disorder

Interventions: Other: Sleep hygiene education
Device: digital CBT-I

Registration Number: NCT05541055

Lead Sponsor: Big Health Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 336

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep hygiene education	Sleep hygiene education	This group will receive access to sleep hygiene education delivered via digital written materials
Digital CBT-I	digital CBT-I	Digitally-delivered CBT for insomnia accessed via web and/or mobile app

Primary Outcome Measures

Name	Time	Method
Change in the Insomnia Severity Index (ISI)	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)	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)	From baseline to 10 weeks post-randomization	Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

Secondary Outcome Measures

Name	Time	Method
Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI	10, 16, and 24 weeks post-randomization	Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Insomnia disorder remission based on the SCID Insomnia Module	Week -1 compared to weeks 10, 16, and 24 post-randomization	structured interview to assess for Insomnia Disorder
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	Each measured in minutes by daily sleep diaries (based on the Consensus Sleep Diary)
Change in the Sleep Condition Indicator (SCI-8)	From baseline to weeks 10, 16, and 24 post-randomization	Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep
Change in the Insomnia Severity Index (ISI)	From baseline to weeks 16 and 24 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)	From baseline to weeks 16 and 24 post-randomization	Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Change in the Patient Health Questionnaire (PHQ-8)	From baseline to weeks 10, 16 and 24 post-randomization	Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Change in wake after sleep onset (WASO)	From baseline to weeks 16 and 24 post-randomization	Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)	From baseline to weeks 10, 16, and 24 post-randomization	Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity