Hypertension With Unsatisfactory Sleep Health (HUSH)

実験的：Brief Behavioral Treatment for Insomnia

Brief Behavioral Treatment for Insomnia (BBTI) employs behavioral strategies for managing insomnia and is administered in 4 brief weekly contacts with a therapist via online web conferencing.

行動：Brief Behavioral Treatment for Insomnia

BBTI employs behavioral strategies for treating insomnia, including stimulus control and sleep restriction. The BBTI interventionist contacts occur by telephone or web conferencing. It is administered in an initial session, followed by 3 brief weekly contacts, each guided by a printed workbook. During an initial 60 minute session, the sleep interventionist will review the participant's insomnia symptoms, discuss sleep regulation, and develop an individualized prescription of sleep wake times.

他の名前：

• BBTI

実験的：Sleep Healthy Using the Internet (SHUTi)

SHUTi is an automated, interactive, personalized web-based program for improving insomnia through the use of Cognitive-Behavioral Therapy strategies for insomnia.

行動：Sleep Healthy Using the Internet

SHUTi is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of Cognitive Behavioral Treatment for Insomnia (CBT-I): sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is metered out over 6 Cores based on a time and event-based schedule. SHUTi uses online sleep diaries to track progress and to tailor treatment (e.g., assign a "sleep restriction" window). Each Core acts as an online analog for the weekly sessions of traditional CBT-I and follows the same structure.

他の名前：

• シュティ

プラセボコンパレーター：Enhanced Usual Care (EUC)

EUC involves the primary care physician's current treatment; feedback to patients and providers on assessment and treatment recommendations; an educational video from Emmi Solutions, Inc.

行動：Enhanced Usual Care

Participants randomized to EUC will complete the standard panel of self-report assessments and home blood pressure monitoring at baseline. The study team will generate an individualized report based, which will be sent to the participant and physician. The report will also contain publically-available educational resources (websites, books) and contact information for treatment resources. Participants in EUC will be given a link to a website containing an educational video on insomnia and its treatment, produced by Emmi Solutions, Inc. Participants in EUC will complete outcome assessments on the same schedule as participants in the other conditions. Participants who complete the EUC intervention will be offered the CBT-I/ SHUTi intervention following study completion.

他の名前：

• EUC

Sleep Disturbance

Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance:

PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 27-item item bank.

Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of ~20 - ~80. Higher scores indicate greater Sleep Disturbance.

Depression

The PROMIS Depression Scale is a self-report measure that assesses negative mood, views of self, social cognition, affect and engagement during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 28-item bank.

Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of ~20 - ~80. Higher scores indicate greater Depression.

Anxiety

The PROMIS Anxiety Scale is a self-report measure that assesses fear, anxiousness, and hyperarousal and its associated somatic symptoms during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 29-item bank.

Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of ~20 - ~80. Higher scores indicate greater Anxiety.

Fatigue

The PROMIS Fatigue Scale is a self-report measure that assesses the experience and impact of fatigue during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 95-item bank.

Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of ~20 - ~80. Higher scores indicate greater Fatigue.

Blood Pressure

Home blood pressures are measured with an Omron BP786 home blood pressure monitor. Reported values for each day in each participant represent the average systolic and diastolic readings and heart rate from 3 measurements. Participants record these values in a 7-day sleep diary. Daily measurements for each participant are averaged across the number of days of recording.

Scale Range: Systolic BP range: 0 - 299; Diastolic BP range: 0 - 299; Heart rate range: 40 - 180. These values represent the reliable ranges for the device. For each variable, higher values are generally considered "worse" and lower values "better." However, very low values (e.g., systolic BP values <80, diastolic BP values <60, and HR values <50) may also indicate poor cardiovascular health.

Hypnotic Use

Daily hypnotic use is self-reported in a 7-day sleep diary, with the ability to report up to 3 medications taken on a given night.

Scale Range: 22 Minimum Score: 0 (no hypnotic medication use on any day; better) Maximum Score: 21 (multiple hypnotic medications and/or multiple days of use; worse).

Retrospective hypnotic use in past 3 months is self-reported in a demographic and health care utilization questionnaire.

Scale Range: 0 - no limit Minimum Score: 0 (better) Maximum Score: no limit (multiple hypnotic medications and/or multiple days of use; worse).

Health Care Utilization

The Health care utilization Questionnaire is a self-report measure that asks about recent health care services that have been sought and medications for hypertension and insomnia.

Scale Range: 0 - no limit Minimum Score: 0 (no visits or medications; better) Maximum Score: no limit (multiple visits and/or medications; worse)

Health-Related Quality of Life

The Rand-12 is a 12-item self-report measure that produces physical health (PHC) and mental health (MHC) component scores. T-scores are used and have a population mean of 50.

Scale Range (PHC and MHC): 100 Minimum Score (PHC and MHC) = 0 (worse) Maximum Score (PHC and MHC) = 100 (better)

Client Satisfaction

The Client Satisfaction Questionnaire (CSQ) is an 8-item self-report measure that assesses client satisfaction with the services they received.

Scale Range: 24 Minimum Score = 8 (low satisfaction) Maximum Score = 32 (high satisfaction)

Provider Satisfaction

The provider satisfaction questionnaire is a self-report measure that assesses provider's perceived efficacy of the treatments their patients received, barriers to treatment, and satisfaction of both providers and patients.

Scale Range: 38 Minimum Score: 0 (low satisfaction) Maximum Score: 37 (high satisfaction)

Daytime Impairment Related to Sleep

PROMIS Sleep Related Impairment is a self-report measure that assesses problems related to insufficient sleep during the past 7 days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 16-item bank.

Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of ~20 - ~80. Higher scores indicate greater sleep related impairment.

Side Effects

Side effects (frequency, severity, impairment) are recorded via a self-report that was adapted from the Fisber.

Range: 22 Minimum Score: 0 (no side effects; better) Maximum Score: 21 (worse)

Those reporting severity of > moderate and/or frequency > 50% of the time in their self-report, or who spontaneously report a side effect, are contacted by the study coordinator. Information is gathered regarding the nature and duration of the event and action taken. Determination of causality and outcomes attributed to the event are then made.

Insomnia Severity

The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks.

Scale Range: Minimum Score = 0 (no insomnia); Maximum Score = 28 (severe insomnia)

Sleep Quality

The Pittsburgh Sleep Quality Index (PSQI) is an 18-item self-report measure that assesses sleep quality in the past month. These items are combined into seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction). The seven component scores are added to produce a global sleep quality score. Higher global scores reflect lower sleep quality, with 5 as a cut-off distinguishing good from poor sleepers.

Scale Range: 22

Minimum Score = 0 (better); Maximum Score = 21 (worse)

Daytime Sleepiness

The Epworth Sleepiness Scale (ESS) is an 8-item self-report measure that assesses daytime sleepiness by asking about the likelihood of dozing in certain situations. Individual items are summed to yield the ESS score.

Scale Range: 25

Minimum Score = 0 (never doze); Maximum Score = 24 (doze a lot)

Falls

Falls are recorded via self-report.

Range: 5 Minimum Score: 0 (no falls; better) Maximum Score: 5 (> 4 falls; worse)

Those reporting a fall are contacted by the coordinator and information is gathered regarding the date and time of day of the fall(s), proximity to a sleep episode, contributing factors, and whether or not medication for sleep or anxiety were taken in the 24 hours preceding the fall.

Improvement

The Patient Global Impression of Improvement (PGI-I) Scale is a self-report measure that rates perceived response to intervention.

Scale Range: 7 Minimum Score: 1 (very much improved; better) Maximum Score: 7 (very much worse; worse)

Bed times

The in and out of bed times are recorded in a 7-day sleep diary and include: bed time, lights out time, wake time, and out-of-bed time. Bed time is the clock time when the participant got into bed. Lights out time is the clock time when the participant actually attempted to sleep (i.e., turned out the lights). Wake time is the clock time of the participant's final awakening. Out-of-bed time is the clock time they got out of bed for the day.

Ranges for these clock-time variables use 24 hours, with no minimum or maximum value.

Time to fall asleep

Time to fall asleep is recorded in a 7-day sleep diary.

Range: 24 hours Minimum value = 0 minutes (better) Maximum value = 1440 minutes (worse)

Wake After Sleep Onset (WASO)

WASO is recorded in a 7-day sleep diary, and refers to the number of minutes of wakefulness between the time of falling asleep and Wake Time.

Range: 24 hours Minimum value = 0 minutes (better) Maximum value = 1440 minutes (worse)

Subjective Sleep Quality

Subjective sleep quality is recorded in a 7-day sleep diary.

Range: 5 Minimum score: 0 (very poor; worse) Maximum score: 4 (very good; better)

Use of Sleep Medication

Use of sleep medication is recorded in a 7-day sleep diary, with the ability to report up to 3 medications taken on a given night.

Scale Range: 22

Minimum Score: 0 (no sleep medication use on any night; better) Maximum Score: 21 (multiple sleep medications and/or multiple nights of use; worse).

Sleep Efficiency

Sleep Efficiency is calculated from values recorded in a 7-day sleep diary. It refers to the percentage of time asleep while in bed. Time in bed is calculated as (Out of bed time) - (Bed time), in minutes. Sleep efficiency is calculated as (Total sleep time/time in bed) X 100.

Range: 101 Minimum for sleep efficiency: 0% (worse) Maximum for sleep efficiency: 100% (better)