InsomniaHUSHNCT02508129
Hypertension With Unsatisfactory Sleep Health
A study testing Brief Behavioral Treatment for Insomnia and Sleep Healthy Using the Internet in people with Insomnia and Hypertension, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Insomnia, Hypertension
- What is being tested?
- Brief Behavioral Treatment for Insomnia and Sleep Healthy Using the Internet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 542 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Trial of Behavioral Interventions for Insomnia in Hypertensive Patients
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.
Read the 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
- Being tested
- Brief Behavioral Treatment for Insomnia, Sleep Healthy Using the Internet, Enhanced Usual Care
- Keywords
- Insomnia, hypertension, blood pressure, sleep, behavioral treatment, Cognitive Behavioral Treatment of Insomnia (CBTI), Brief Behavioral Treatment of Insomnia (BBTI), pragmatic trial, internet
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment for InsomniaBehavioural
Also called BBTI
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 InternetBehavioural
Also called SHUTi
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 CareBehavioural
Also called EUC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks
Secondary outcomes (9)
Depression
The PROMIS Depression Scale is a self-report measure that assesses negative mood, views of self, social cognition, affect and engagement 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 28-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 Depression.
Measured: 9 weeks, 6 months, 12 months
Anxiety
The PROMIS Anxiety Scale is a self-report measure that assesses fear, anxiousness, and hyperarousal and its associated somatic symptoms 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 29-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 Anxiety.
Measured: 9 weeks, 6 months, 12 months
Fatigue
The PROMIS Fatigue Scale is a self-report measure that assesses the experience and impact of fatigue 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 95-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 Fatigue.
Measured: 9 weeks, 6 months, 12 months
Blood Pressure
Home blood pressures are measured with an Omron BP786 home blood pressure monitor. Reported values for each day in each participant represent the average systolic and diastolic readings and heart rate from 3 measurements. Participants record these values in a 7-day sleep diary. Daily measurements for each participant are averaged across the number of days of recording.
Scale Range: Systolic BP range: 0 - 299; Diastolic BP range: 0 - 299; Heart rate range: 40 - 180. These values represent the reliable ranges for the device. For each variable, higher values are generally considered "worse" and lower values "better." However, very low values (e.g., systolic BP values <80, diastolic BP values <60, and HR values <50) may also indicate poor cardiovascular health.
Measured: 9 weeks, 6 months, 12 months
Hypnotic Use
Daily hypnotic use is self-reported in a 7-day sleep diary, with the ability to report up to 3 medications taken on a given night.
Scale Range: 22 Minimum Score: 0 (no hypnotic medication use on any day; better) Maximum Score: 21 (multiple hypnotic medications and/or multiple days of use; worse).
Retrospective hypnotic use in past 3 months is self-reported in a demographic and health care utilization questionnaire.
Scale Range: 0 - no limit Minimum Score: 0 (better) Maximum Score: no limit (multiple hypnotic medications and/or multiple days of use; worse).
Measured: 9 weeks, 6 months, 12 months
Health Care Utilization
The Health care utilization Questionnaire is a self-report measure that asks about recent health care services that have been sought and medications for hypertension and insomnia.
Scale Range: 0 - no limit Minimum Score: 0 (no visits or medications; better) Maximum Score: no limit (multiple visits and/or medications; worse)
Measured: 9 weeks, 6 months, 12 months
Health-Related Quality of Life
The Rand-12 is a 12-item self-report measure that produces physical health (PHC) and mental health (MHC) component scores. T-scores are used and have a population mean of 50.
Scale Range (PHC and MHC): 100 Minimum Score (PHC and MHC) = 0 (worse) Maximum Score (PHC and MHC) = 100 (better)
Measured: 9 weeks, 6 months, 12 months
Client Satisfaction
The Client Satisfaction Questionnaire (CSQ) is an 8-item self-report measure that assesses client satisfaction with the services they received.
Scale Range: 24 Minimum Score = 8 (low satisfaction) Maximum Score = 32 (high satisfaction)
Measured: 9 weeks
Provider Satisfaction
The provider satisfaction questionnaire is a self-report measure that assesses provider's perceived efficacy of the treatments their patients received, barriers to treatment, and satisfaction of both providers and patients.
Scale Range: 38 Minimum Score: 0 (low satisfaction) Maximum Score: 37 (high satisfaction)
Measured: Following closing of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, Carolinas Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Daniel J. Buysse, M.D., University of Pittsburgh
- Investigators
- Daniel J Buysse, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508129
- Sponsor's protocol ID
- PRO14070337
- Other IDs
- UH2HL125103
- Acronym
- HUSH
- Status last verified
- Sep 2020
- First submitted
- 21 Jul 2015
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will make available to the research community any resource that is presented in a publication that is published or accepted for publication. 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. Data will be provided in the form of an Access data base. A data dictionary will be provided to define all data fields. We will not provide data analytic tools. We are providing this Data Sharing Agreement in keeping with the requirements of RFA-HL-14-019. Data will be shared as Access data base(s), provided in electronic format by e-mail or durable media.
Publications
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.
PubMed 28587609
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial of Behavioral Interventions for Insomnia in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02508129
- Acronym / sponsor ID
- HUSH / PRO14070337
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Virginia, Carolinas Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2015
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Treatment for Insomnia | Experimental | Behavioral: Brief Behavioral Treatment for InsomniaBrief 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. |
| Sleep Healthy Using the Internet (SHUTi) | Experimental | Behavioral: Sleep Healthy Using the InternetSHUTi is an automated, interactive, personalized web-based program for improving insomnia through the use of Cognitive-Behavioral Therapy strategies for insomnia. |
| Enhanced Usual Care (EUC) | Placebo comparator | Behavioral: Enhanced Usual CareEUC 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Hypertension diagnosis 'Hypertension diagnosis' is indicated by the presence of at least one of the following:
- At least one of the following:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Behavioral Treatment for InsomniaAlso: BBTIBBTI 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. | Behavioural | Brief Behavioral Treatment for Insomnia |
| Sleep Healthy Using the InternetAlso: SHUTiSHUTi 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. | Behavioural | Sleep Healthy Using the Internet (SHUTi) |
| Enhanced Usual CareAlso: EUCParticipants 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. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
Sleep Disturbance
Time frame: 9 weeks
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 secondary outcomes
Depression
Time frame: 9 weeks, 6 months, 12 months
Anxiety
Time frame: 9 weeks, 6 months, 12 months
Fatigue
Time frame: 9 weeks, 6 months, 12 months
Blood Pressure
Time frame: 9 weeks, 6 months, 12 months
Hypnotic Use
Time frame: 9 weeks, 6 months, 12 months
Health Care Utilization
Time frame: 9 weeks, 6 months, 12 months
Health-Related Quality of Life
Time frame: 9 weeks, 6 months, 12 months
Client Satisfaction
Time frame: 9 weeks
Provider Satisfaction
Time frame: Following closing of recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 28587609Levenson 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.
- Individual participant dataSharing planned: Yes. We will make available to the research community any resource that is presented in a publication that is published or accepted for publication. 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. Data will be provided in the form of an Access data base. A data dictionary will be provided to define all data fields. We will not provide data analytic tools. We are providing this Data Sharing Agreement in keeping with the requirements of RFA-HL-14-019. Data will be shared as Access data base(s), provided in electronic format by e-mail or durable media.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Buysse, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment for Insomnia and Sleep Healthy Using the Internet in people with Insomnia and Hypertension, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Disturbance (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.