Hypertension With Unsatisfactory Sleep Health

NCT02508129 | Completed DMC

• 2 other identifiers: PRO14070337UH2HL125103
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Hypertension

Keywords

Insomnia; hypertension; blood pressure; sleep; behavioral treatment; Cognitive Behavioral Treatment of Insomnia (CBTI); Brief Behavioral Treatment of Insomnia (BBTI); pragmatic trial; internet

Outcome Measures

Primary Outcomes (1)

• Sleep Disturbance

  Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance: PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 27-item item bank. Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of \~20 - \~80. Higher scores indicate greater Sleep Disturbance.

  9 weeks

Secondary Outcomes (9)

• Depression

  9 weeks, 6 months, 12 months

• Anxiety

  9 weeks, 6 months, 12 months

• Fatigue

  9 weeks, 6 months, 12 months

• Blood Pressure

  9 weeks, 6 months, 12 months

• Hypnotic Use

  9 weeks, 6 months, 12 months

Other Outcomes (13)

• Daytime Impairment Related to Sleep

  9 weeks, 6 months, 12 months

• Side Effects

  9 weeks, 6 months, 12 months

• Insomnia Severity

  9 weeks, 6 months, 12 months

Study Arms (3)

Brief Behavioral Treatment for Insomnia

EXPERIMENTAL

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

Sleep Healthy Using the Internet (SHUTi)

EXPERIMENTAL

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

Enhanced Usual Care (EUC)

PLACEBO COMPARATOR

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

Interventions

Brief Behavioral Treatment for Insomnia BEHAVIORAL

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.

Also known as: BBTI

Brief Behavioral Treatment for Insomnia

Sleep Healthy Using the Internet BEHAVIORAL

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.

Also known as: SHUTi

Sleep Healthy Using the Internet (SHUTi)

Enhanced Usual Care BEHAVIORAL

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.

Also known as: EUC

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension diagnosis 'Hypertension diagnosis' is indicated by the presence of at least one of the following:
• International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis of essential hypertension in the electronic health record;
• Hypertension listed in the medical problem list in the electronic health record.
• At least one of the following:
• Hypnotic on active med list
• Insomnia on diagnosis or problem list
• Age 18 years and up.
• Meets criteria for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5th ed.) Insomnia Disorder
• At least moderate insomnia severity: Score \> 7 on Insomnia Severity Index
• 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.
• Stable medical, psychiatric condition

You may not qualify if:

• 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
• History of bipolar disorder or psychosis
• Substance use disorder within past 3 months
• Dementia or probable dementia diagnosis
• Active suicidal ideation or psychosis
• Delayed sleep phase disorder (DSPD) or severe, untreated restless legs syndrome (RLS)
• Plans to leave present source of care during the following year
• Non-English speaking, illiterate, or sensory deficits
• Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
• Apnea Hypopnea Index (AHI) greater than or equal to 50 or O2 saturation 85% or less for \> or = to 10% of the night.

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Virginia: collaborator
• Carolinas Medical Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UPMC Health System

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Levenson JC, Rollman BL, Ritterband LM, Strollo PJ, Smith KJ, Yabes JG, Moore CG, Harvey AG, Buysse DJ. Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. Trials. 2017 Jun 6;18(1):256. doi: 10.1186/s13063-017-2001-9.

  PMID: 28587609 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Hypertension

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel J Buysse, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 24, 2015
• Study Start: August 1, 2015
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: We agree to release and share data in a timely manner, but no later than one year following completion of the funded project period or the date of publication of the main findings from our final data set.
• Access Criteria: We will share data with investigators working at an institution with a Federal Wide Assurance. To gain access to data, researchers must submit a detailed description of their project. The proposal must include the investigator's personal identification and institutional affiliation, a current CV, qualifications, estimated duration of the proposed research, source of financial support, and a conflict of interest statement. The protocol described must include study aims, background and significance, and methods and types of analysis, and a description of the data requested and list of variables. Once approved, the investigator must complete the necessary University of Pittsburgh IRB exempt research application form and document completion of a responsible conduct of research program. Data will be prepared by an 'honest broker.' Data will not be provided that could identify individual research participants or that the original consent form expressly forbade.

Locations

US (1)