Hypertension With Unsatisfactory Sleep Health

NCT ID: NCT02508129

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 542 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-03-05

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.

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"

Conditions

Insomnia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Brief Behavioral Treatment for Insomnia

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Sleep Healthy Using the Internet

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Enhanced Usual Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

BBTI; SHUTi; EUC

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Carolinas Medical Center

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Daniel J. Buysse, M.D.

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J Buysse, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Health System

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28587609 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

UH2HL125103

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO14070337

Identifier Type: -

Identifier Source: org_study_id