Digital CBT-I for Insomnia Disorder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insomnia Disorder

Intervention / Treatment
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* Device: digital CBT-I
* Other: Sleep hygiene education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital CBT-I<br>Digitally-delivered CBT for insomnia accessed via web and/or mobile app | Device: digital CBT-I<br>* A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia.<br>|
| Active Comparator: Sleep hygiene education<br>This group will receive access to sleep hygiene education delivered via digital written materials | Other: Sleep hygiene education<br>* Participants will be provided with sleep hygiene advice which will be delivered digitally all at once upon allocation to the SHE arm. Participants will be able to revisit content during the trial as they wish.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Insomnia Severity Index (ISI) | Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity | From baseline to 10 weeks post-randomization | 
| Change in sleep onset latency (SOL) | Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days | From baseline to 10 weeks post-randomization | 
| Change in wake after sleep onset (WASO) | Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days | From baseline to 10 weeks post-randomization | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, digital CBT, CBT-I