Hypertension With Unsatisfactory Sleep Health
Condition: Insomnia; Hypertension
MeSH terms: Sleep Initiation and Maintenance Disorders; Hypertension
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      We made changes to the outcome measures document in April, 2019, and further amended these
      measures in June, 2019. The reason for these changes was to ensure consistency among the
      grant application, clinical trial protocol paper, and ClinicalTrials.gov. We made the
      following specific changes and corrections:

        -  Insomnia diagnosis, cumulative illness rating scale, and treatment expectations were
           removed as secondary outcomes, as they are not listed in our protocol as outcome
           measures. They are only measured at baseline to characterize participants.

        -  Health-Related Quality of Life "Medical Outcomes Survey Short Form-12 and Client
           Satisfaction "Client Satisfaction Questionnaire" were changed from primary to secondary
           outcome measures, to ensure consistency with the grant application and protocol paper.

        -  Side effects "Treatment-related Side Effects Scale" were changed from a secondary to an
           "other" outcome measure, again to ensure consistency with the grant application and
           protocol paper.

      The following outcome measures were added to ClinicalTrials.gov to ensure consistency:

      Secondary Outcome: Provider Satisfaction "Provider Satisfaction Survey"

      Other Prespecified Outcome Measures:

        -  Daytime Impairment Related to Sleep "PROMIS Sleep Related Impairment"

        -  Insomnia Severity "Insomnia Severity Index"

        -  Sleep Quality "Pittsburgh Sleep Quality Index"

        -  Daytime Sleepiness "Epworth Sleepiness Scale"

        -  Falls "Side Effect/Falls Questionnaire" "Falls Follow-up Questionnaire"

        -  Improvement "Patient Global Impression of Improvement Scale"

        -  Sleep Diary Measures "HUSH Daily Diary"

      We also recognized that we had erroneously interpreted "time frame" as the time frame of the
      instrument itself, rather than the time frame of the assessment battery. Time frames in
      ClinicalTrials.gov were corrected to capture the time points at which they are assessed, in
      the following measures:

        -  Sleep disturbance "PROMIS Sleep Disturbance Scale"

        -  Health related quality of life "Medical Outcomes Survey Short Form-12"

        -  Client satisfaction "Client Satisfaction Questionnaire"

        -  Depression "PROMIS Depression Scale"

        -  Anxiety "PROMIS Anxiety Scale"

        -  Fatigue "PROMIS Fatigue Scale"

        -  Blood pressure "HUSH Sleep Diary"

        -  Hypnotic use "Health Care Utilization Questionnaire" "HUSH Sleep Diary"

        -  Health care costs "Health Care Utilization Questionnaire"

        -  Side effects "Treatment-related Side Effects Scale"
    

Intervention name(s): Brief Behavioral Treatment for Insomnia; Sleep Healthy Using the Internet; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): BBTI; SHUTi; EUC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Insomnia; hypertension; blood pressure; sleep; behavioral treatment; Cognitive Behavioral Treatment of Insomnia (CBTI); Brief Behavioral Treatment of Insomnia (BBTI); pragmatic trial; internet