Table 2.
Schedule of Enrollment, Intervention, and Assessments
| Study period | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment | Allocation | Post-allocation | Close-out | ||||||||||
| Screening | |||||||||||||
| Baseline | Intervention | Post-tx | |||||||||||
| Timepoint | -t2 | -t1 | 0 | t1 | t2 | t3 | t4 | t5 | t6 | t7 | t8 | t9 | t10 |
| Surveys & Interviews | In-lab PSG | Behavioral Testing | Surveys & interviews | In-lab PSG | Behavioral Testing | ||||||||
| Enrollment | |||||||||||||
| Eligibility screen | X | ||||||||||||
| Informed consent | X | ||||||||||||
| Allocation | X | ||||||||||||
| Intervention | |||||||||||||
| CBT-I |
|
||||||||||||
| Waitlist |
|
||||||||||||
| Assessment | |||||||||||||
| Primary and secondary measures | |||||||||||||
| REM fragmentation | |||||||||||||
| At-home PSG (4 nights) |
X | X | |||||||||||
| Fear inhibition – extinction recall (primary); safety signal recall (secondary) | |||||||||||||
| FPS task (3 mornings) |
X | X | |||||||||||
| Serum estradiol (E2) | X | X | |||||||||||
| Other measures | |||||||||||||
| Eligibility measures | |||||||||||||
| Alcohol Use Disorders Identification Test (AUDIT) | X | X | |||||||||||
| Drug Use Disorders Identification Test (DUDIT) | X | X | |||||||||||
| Structured Clinical Interview for DSM-5 (SCID-5) | X | ||||||||||||
| Structured Clinical Interview for Sleep Disorders revised (SCISD-R) | X | X | |||||||||||
| Hot Flash Related Daily Interference Scale (HFRDIS) | X | ||||||||||||
| Daily measures | |||||||||||||
| Sleep Diaries |
|
||||||||||||
| Fitbit |
|
||||||||||||
| Treatment-related measures | |||||||||||||
| Credibility Expectancy Questionnaire (CEQ) | X | ||||||||||||
| Client Adherence Form (CAF) | X | X | X | X | X | X | |||||||
| Adverse Effects Scale | X | X | X | X | X | ||||||||
| Client Satisfaction Questionnaire (CSQ) | X | ||||||||||||
| Other descriptive and exploratory measures | |||||||||||||
| Sleep-related Measures | |||||||||||||
| Insomnia Severity Index (ISI) | X | X | X | X | X | X | X | X | X | ||||
| Epworth Sleepiness Scale (ESS) | X | X | |||||||||||
| PROMIS Sleep-Related Impairment | X | X | |||||||||||
| Sleep Hygiene Index | X | X | |||||||||||
| Flinders Fatigue Scale (FFS) | X | X | |||||||||||
| Ford Insomnia Response to Stress (FIRST) | X | X | |||||||||||
| Dysfunctional Beliefs About Sleep (DBAS) | X | X | |||||||||||
| Munich Chronotype Questionnaire (MCTQ core) | X | X | |||||||||||
| Reduced Morningness Eveningness Questionnaire (MEQr) | X | X | |||||||||||
| Presleep Arousal Scale | X | X | X | X | X | ||||||||
| Iowa Resistance to Sleeplessness Test | X | ||||||||||||
| Karolinska Sleepiness Scale (KSS) | X | X | X | X | |||||||||
| Mental health-related measures | |||||||||||||
| Patient Health Questionnaire-9 (PHQ-9) | X | X | |||||||||||
| PROMIS Anxiety – SF 8a | X | X | |||||||||||
| Life Events Checklist for DSM-5 (LEC-5) | X | X | |||||||||||
| PTSD Checklist-5 (PCL-5) | X | X | |||||||||||
| PROMIS Satisfaction – SF 8a | X | X | |||||||||||
| Warwick Edinburgh Mental Well-being Scale (WEMWBS) | X | X | |||||||||||
| Brief Self-Control Scale (BSCS) | X | ||||||||||||
| Intolerance of Uncertainty Scale (IUS-12) | X | ||||||||||||
| Spielberger State-Trait Anxiety Inventory (STAI) | X | X | X | X | |||||||||
| Cognitive functioning-related measures | |||||||||||||
| British Columbia Cognitive Complaints Inventory (BC-CCI) | X | X | X | ||||||||||
| Paired Associates Learning (PAL) | X | X | |||||||||||
SPIRIT flow diagram outlining the schedule of enrollment, intervention, and assessments. CBT-I, cognitive behavioral therapy for insomnia; PSG, polysomnography.