Pittsburgh, Pennsylvania 15213


Purpose:

Insomnia and hypertension are common health problems that often occur together and influence each other. This practical, low-cost, clinical trial will evaluate two behavioral treatments for insomnia (a brief intervention with therapist contact and a self-guided Internet intervention) compared to usual care. Participants 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 9 weeks, 6 months, and 12 months.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02508129


Primary Contact:

Principal Investigator
Daniel J Buysse, MD
University of Pittsburgh

Laurie Brar, MSN, CRNP
Phone: 412-246-6445
Email: brarlk@upmc.edu


Backup Contact:

Email: deluciaa@upmc.edu
Alexandra DeLucia, BA
Phone: 412-246-6474


Location Contact:

Pittsburgh, Pennsylvania 15213
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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