Hypertension With Unsatisfactory Sleep Health (HUSH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02508129
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : November 1, 2018
University of Virginia
Carolinas Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Daniel J. Buysse, M.D., University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia Hypertension Behavioral: Brief Behavioral Treatment for Insomnia Behavioral: Sleep Healthy Using the Internet Behavioral: Enhanced Usual Care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pragmatic Trial of Behavioral Interventions for Insomnia in Hypertensive Patients
Study Start Date : August 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: BBTI

Experimental: 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.
Behavioral: 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.
Other Name: SHUTi

Placebo Comparator: 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.
Behavioral: 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.
Other Name: EUC

Primary Outcome Measures :
  1. Sleep disturbance [ Time Frame: One week ]
    Score on the Sleep Disturbance scale from the Patient-Reported Outcomes Measurement Information System (PROMIS)

  2. Health-related quality of life [ Time Frame: 4 weeks ]
    Medical Outcomes Survey Short form-12 (SF-12)

  3. Client satisfaction [ Time Frame: Two months ]
    Client satisfaction questionnaire

Secondary Outcome Measures :
  1. Insomnia diagnosis [ Time Frame: One month ]
    Diagnostic and Statistical Manual (DSM-5) insomnia diagnosis checklist

  2. Depression [ Time Frame: One week ]
    PROMIS depression scale score

  3. Anxiety [ Time Frame: One week ]
    PROMIS anxiety scale score

  4. Fatigue [ Time Frame: One week ]
    PROMIS fatigue scale score

  5. Blood pressure [ Time Frame: One week ]
    Mean blood pressure from home blood pressure monitoring

  6. Hypnotic use [ Time Frame: One month ]
    Use of hypnotic medication over past one month

  7. Health care costs [ Time Frame: 3 months ]
    Health Care Costs questionnaire

  8. Illness rating [ Time Frame: 3 months ]
    Cumulative Illness Rating Scale

  9. Treatment expectations [ Time Frame: One week ]
    Treatment expectations questionnaire

  10. Side effects [ Time Frame: Two months ]
    Treatment-related side effects scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02508129

Contact: Laurie Brar, MSN, CRNP 412-246-6445
Contact: Alexandra DeLucia, BA 412-246-6474

United States, Pennsylvania
UPMC Health System Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Daniel J Buysse, M.D.         
Sub-Investigator: Bruce Rollman, M.D.         
Sub-Investigator: Patrick J Strollo, M.D.         
Sub-Investigator: Lee Ritterband, Ph.D.         
Sub-Investigator: Charity Moore, Ph.D.         
Sub-Investigator: Jonathan Yabes, Ph.D.         
Sub-Investigator: Kenneth Smith, M.D.         
Sponsors and Collaborators
University of Pittsburgh
University of Virginia
Carolinas Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Daniel J Buysse, MD University of Pittsburgh

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daniel J. Buysse, M.D., Professor of Psychiatry, University of Pittsburgh Identifier: NCT02508129     History of Changes
Other Study ID Numbers: PRO14070337
UH2HL125103 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently undecided as to whether data will be shared.

Keywords provided by Daniel J. Buysse, M.D., University of Pittsburgh:
blood pressure
behavioral treatment
Cognitive Behavioral Treatment of Insomnia (CBTI)
Brief Behavioral Treatment of Insomnia (BBTI)
pragmatic trial

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders