Hypertension With Unsatisfactory Sleep Health

Insomnia is a prevalent, chronic, and inadequately-treated chronic medical condition
associated with comorbid conditions such as hypertension (HTN) and a range of adverse health
outcomes. Hypnotic medications are efficacious and widely available, but they have
potentially serious adverse effects. Patients and providers prefer non-drug treatments such
as Cognitive-Behavioral Treatment of Insomnia (CBT-I), which is safe, efficacious, and
durable—but not widely available. Innovative use of electronic health records (EHR) to
identify patients, and the availability of new technologies that enable cognitive-behavioral
interventions to be delivered at scale, with high treatment fidelity, and at low cost, offer
exciting opportunities to address these critical problems. The investigators propose a
low-cost, pragmatic, patient-centered, randomized controlled trial comparing two CBT-I-based
interventions for insomnia with comorbid hypertension (INS+HTN) to primary care physicians'
(PCP) enhanced usual care (EUC). The setting will be University of Pittsburgh Medical Center
(UPMC) primary care practices. Participants will be 625 adults with INS+HTN. Recruitment will
be conducted using alerts in the EpicCare EHR triggered by patient characteristics
(hypertension; hypnotic medications or insomnia diagnosis/problem). The investigators will
compare 3 interventions: Brief Behavioral Treatment of Insomnia (BBTI), involving electronic
educational material and 4 telephone/web sessions with a live interventionist; "Sleep Healthy
Using The Internet" (SHUTi), a self-guided, 8-module, Internet version of CBT-I, with no
human contact; and EUC, which includes assessment and educational information for
participants and providers. The primary outcome will be self-reported sleep at 9 weeks. Other
outcomes include domains of symptoms, health, and patient/provider satisfaction obtained by
self-report, home blood pressure monitoring (HBPM), and EHR. Specific Aims for the trial are:
(1) To compare interventions on patient-reported symptoms at 9 weeks, 6 months, and 12
months. (2) To compare interventions on health indicators including self-report, HBPM, and
EHR measures at 6 and 12 months. (3) To compare patient and provider-level satisfaction with
the 3 interventions. (4) Exploratory Aim: To compare BBTI and CBT-I on each outcome domain
and intervention adherence/drop-outs.

Inclusion Criteria:

1. Hypertension diagnosis 'Hypertension diagnosis' is indicated by the presence of at
least one of the following:

1. International Classification of Diseases, Ninth Revision, Clinical Modification
(ICD-9-CM) diagnosis of essential hypertension in the electronic health record;

2. Hypertension listed in the medical problem list in the electronic health record.

2. At least one of the following:

1. Hypnotic on active med list

2. Insomnia on diagnosis or problem list

3. Age 18 years and up.

4. Meets criteria for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5th
ed.) Insomnia Disorder

5. At least moderate insomnia severity: Score > 7 on Insomnia Severity Index

6. Telephone, e-mail address, reliable Internet access. 'Reliable internet access' is
defined by an individual having a personal e-mail address and having regular internet
access within his/her own residence.

7. Stable medical, psychiatric condition

Exclusion Criteria:

1. Untreated current major depression (Patient Health Questionnaire (PHQ-9) score equal
to or greater than 15; Generalized Anxiety Disorder (GAD-7) score > 10); patients
using stable (3 mos) medication, psychological treatment ARE eligible

2. History of bipolar disorder or psychosis

3. Substance use disorder within past 3 months

4. Dementia or probable dementia diagnosis

5. Active suicidal ideation or psychosis

6. Delayed sleep phase disorder (DSPD) or severe, untreated restless legs syndrome (RLS)

7. Plans to leave present source of care during the following year

8. Non-English speaking, illiterate, or sensory deficits

9. Shift work that includes working the night shift (between the hours of 12:00 a.m. -
6:00 a.m.)

10. Apnea Hypopnea Index (AHI) greater than or equal to 50 or O2 saturation 85% or less
for > or = to 10% of the night.