Hypertension With Unsatisfactory Sleep Health
Completed · Not applicable
Conditions studied: Insomnia, Hypertension
In brief
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.
Key facts
- Study ID
- NCT02508129
- Run by
- University of Pittsburgh
- People needed
- 542
- Starts
- 2015-08-01
- Expected to finish
- 2020-03-05
- Last updated by the study team
- 2020-09-03
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- UPMC Health System — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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