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Participant Enrollment ┌────────────────────────────────────────────────────────────────────┐ │ Participant Recruitment (N=240) │ │ - Veterans, firefighters, healthcare workers invited by 62Romeo │ │ - If interested ⇒ proceed to eligibility screen │ └────────────────────────────────────────────────────────────────────┘ ┃ ▼ ┌────────────────────────────────────────────────────────────────────┐ │ Eligibility Screen │ │ - Criteria: 18+ years old, chronic insomnia, generally healthy │ │ - Exclude if severe comorbidities or already in sleep treatment │ │ - If eligible ⇒ provide information & consent │ └────────────────────────────────────────────────────────────────────┘ ┃ ▼ ┌────────────────────────────────────────────────────────────────────┐ │ Information & Consent │ │ - Explain 6-week CBT-I program + sleep device usage │ │ - Address data privacy, voluntary participation, etc. │ │ - If consent is given ⇒ proceed to single-arm allocation │ └────────────────────────────────────────────────────────────────────┘ ┃ ▼ ┌────────────────────────────────────────────────────────────────────┐ │ Allocation: Single-Arm Design │ │ - Entire cohort receives 6-week group-based CBT-I + Rest Node │ │ - Nightly objective measurement via under-mattress sensor │ └────────────────────────────────────────────────────────────────────┘ ┃ ▼ ┌────────────────────────────────────────────────────────────────────┐ │ T1: Baseline (Pre-Test) │ │ - Self-reported assessments: ISI, PSQI, GAD-7, PHQ-9 │ │ - Objective data: Sleep latency, deep sleep, REM sleep, │ │ nighttime awakenings │ │ - N=240 (initial expected sample) │ └────────────────────────────────────────────────────────────────────┘ ┃ ▼ ┌────────────────────────────────────────────────────────────────────┐ │ 6-Week Group-Delivered CBT-I Intervention │ │ - Weekly sessions (CBT for insomnia, stimulus control, etc.) │ │ - Automated Rest Node device for breathing exercises & white │ │ noise (reduces phone/light use) │ │ - Ongoing objective data collection each night │ └────────────────────────────────────────────────────────────────────┘ ┃ ▼ ┌────────────────────────────────────────────────────────────────────┐ │ T2: Post-Intervention (End of 6 Weeks) │ │ - Repeat self-reported assessments (ISI, PSQI, GAD-7, PHQ-9) │ │ - Compare with T1 data to evaluate short-term changes │ │ - Objective sleep data downloaded & analyzed │ └────────────────────────────────────────────────────────────────────┘ ┃ ▼ ┌────────────────────────────────────────────────────────────────────┐ │ T3: 6-Month Follow-Up (Ongoing) │ │ - Assess sustainability of improvements │ │ - Same questionnaires + nightly sensor data (if still in use) │ │ - Dropouts or missing data accounted for in analysis │ └────────────────────────────────────────────────────────────────────┘ ┃ ▼ ┌────────────────────────────────────────────────────────────────────┐ │ Data Analysis & Interpretation │ │ - SPSS for paired t-tests or repeated-measures ANOVA │ │ - Primary outcomes: Sleep latency, ISI, PSQI │ │ - Secondary outcomes: GAD-7, PHQ-9, deep & REM sleep │ │ - Subgroup exploration (veterans vs. firefighters, etc.) │ │ - Final publication & recommendations │ └────────────────────────────────────────────────────────────────────┘
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