Hypertension With Unsatisfactory Sleep Health (HUSH)
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|ClinicalTrials.gov Identifier: NCT02508129|
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : October 31, 2017
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||625 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- Sleep disturbance [ Time Frame: One week ]Score on the Sleep Disturbance scale from the Patient-Reported Outcomes Measurement Information System (PROMIS)
- Health-related quality of life [ Time Frame: 4 weeks ]Medical Outcomes Survey Short form-12 (SF-12)
- Client satisfaction [ Time Frame: Two months ]Client satisfaction questionnaire
- Insomnia diagnosis [ Time Frame: One month ]Diagnostic and Statistical Manual (DSM-5) insomnia diagnosis checklist
- Depression [ Time Frame: One week ]PROMIS depression scale score
- Anxiety [ Time Frame: One week ]PROMIS anxiety scale score
- Fatigue [ Time Frame: One week ]PROMIS fatigue scale score
- Blood pressure [ Time Frame: One week ]Mean blood pressure from home blood pressure monitoring
- Hypnotic use [ Time Frame: One month ]Use of hypnotic medication over past one month
- Health care costs [ Time Frame: 3 months ]Health Care Costs questionnaire
- Illness rating [ Time Frame: 3 months ]Cumulative Illness Rating Scale
- Treatment expectations [ Time Frame: One week ]Treatment expectations questionnaire
- Side effects [ Time Frame: Two months ]Treatment-related side effects scale
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 ClinicalTrials.gov identifier (NCT number): NCT02508129
|Contact: Laurie Brar, MSN, CRNPfirstname.lastname@example.org|
|Contact: Alexandra DeLucia, BAemail@example.com|
|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.|
|Principal Investigator:||Daniel J Buysse, MD||University of Pittsburgh|