Clinical trial NCT02508129: Hypertension With Unsatisfactory Sleep Health
Official title: Pragmatic Trial of Behavioral Interventions for Insomnia in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: Carolinas Medical Center
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-07-24
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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"

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.

Primary outcomes:
measure: Sleep Disturbance
timeFrame: 9 weeks
Secondary outcomes:
measure: Depression
timeFrame: 9 weeks, 6 months, 12 months
measure: Anxiety
timeFrame: 9 weeks, 6 months, 12 months
measure: Fatigue
timeFrame: 9 weeks, 6 months, 12 months
measure: Blood Pressure
timeFrame: 9 weeks, 6 months, 12 months
measure: Hypnotic Use
timeFrame: 9 weeks, 6 months, 12 months
measure: Health Care Utilization
timeFrame: 9 weeks, 6 months, 12 months
measure: Health-Related Quality of Life
timeFrame: 9 weeks, 6 months, 12 months
measure: Client Satisfaction
timeFrame: 9 weeks
measure: Provider Satisfaction
timeFrame: Following closing of recruitment
Other outcomes:
measure: Daytime Impairment Related to Sleep
timeFrame: 9 weeks, 6 months, 12 months
measure: Side Effects
timeFrame: 9 weeks, 6 months, 12 months
measure: Insomnia Severity
timeFrame: 9 weeks, 6 months, 12 months
measure: Sleep Quality
timeFrame: 9 weeks, 6 months, 12 months
measure: Daytime Sleepiness
timeFrame: 9 weeks, 6 months, 12 months
measure: Falls
timeFrame: 9 weeks, 6 months, 12 months
measure: Improvement
timeFrame: 9 weeks, 6 months, 12 months
measure: Bed times
timeFrame: Intervention, 9 weeks, 6 months, 12 months
measure: Time to fall asleep
timeFrame: Intervention, 9 weeks, 6 months, 12 months
measure: Wake After Sleep Onset (WASO)
timeFrame: Intervention, 9 weeks, 6 months, 12 months
measure: Subjective Sleep Quality
timeFrame: Intervention, 9 weeks, 6 months, 12 months
measure: Use of Sleep Medication
timeFrame: Intervention, 9 weeks, 6 months, 12 months
measure: Sleep Efficiency
timeFrame: Intervention, 9 weeks, 6 months, 12 months
Locations:
city: Pittsburgh
country: United States
facility: UPMC Health System
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Daniel J Buysse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.