Untitled

 avatar
unknown
plain_text
a month ago
7.1 kB
2
Indexable
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                            │
 └────────────────────────────────────────────────────────────────────┘
Leave a Comment