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. In response to RFA-HL-14-019, we 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) usual care (UC). 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). We 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 UC. The primary outcome will be self-reported sleep at 3 months. 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 UH2 phase are: (1) To finalize institutional infrastructure and (2) To finalize the trial infrastructure.
Specific Aims fr the UH3 phase are: (1) To compare interventions on patient-reported symptoms at 3, 6, and 12 months. The primary outcome is the PROMIS Sleep Disturbance scale at 3 months. Hypothesis: BBTI and CBT-I will be superior to UC on patient-reported outcomes. (2) To compare interventions on health indicators including self-report, HBPM, and EHR measures at 6 and 12 months. Hypothesis: BBTI and CBT-I will be superior to UC on each health outcome. (3) To compare patient and provider-level satisfaction with the 3 interventions. Hypothesis: BBTI and CBT-I will be superior to UC on patient and provider satisfaction. (4) Exploratory Aim: To compare BBTI and CBT-I on each outcome domain and intervention adherence/drop-outs. This proposal capitalizes on our expertise in traditional and internet insomnia interventions, collaboration with UPMC and primary care practices, and EHR-based recruitment;it addresses a significant health problem using a scalable model of screening and treatment;it assesses outcomes relevant to patients, providers, and health systems;it uses an innovative EHR recruitment strategy;and it integrates efficacious, low-cost, scalable, pragmatic sleep interventions into primary care settings.

Public Health Relevance

Insomnia and hypertension are common health problems that often occur together and influence each other, but the management of insomnia with hypertension in primary care settings is less than ideal. This practical, low-cost, clinical trial will evaluate two behavioral treatments for insomnia (a bref intervention with therapist contact and a self-guided Internet intervention) compared to usual care. Participants with insomnia and hypertension will be recruited using the electronic health record in their primary care physicians'offices, and will be evaluated for sleep, blood pressure, and health outcomes after 3, 6, and 12 months.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Exploratory/Developmental Cooperative Agreement Phase I (UH2)
Project #
1UH2HL125103-01
Application #
8792640
Study Section
Special Emphasis Panel (ZHL1-CSR-G (S1))
Program Officer
Stoney, Catherine
Project Start
2014-09-19
Project End
2015-07-31
Budget Start
2014-09-19
Budget End
2015-07-31
Support Year
1
Fiscal Year
2014
Total Cost
$555,818
Indirect Cost
$134,390
Name
University of Pittsburgh
Department
Psychiatry
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213