Online CBT-I for High Blood Pressure

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of 6-weekly, 20 minute sessions of 2 online behavioral sleep interventions (cognitive behavioral therapy or healthy sleep habits) on blood pressure, sleep, depressive symptoms and anxiety in people with insomnia and prehypertension or hypertension.

Detailed Description
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Approximately 30% of US adults have prehypertension (untreated blood pressure ≥120-139/80-89 mmHg) and 29% have hypertension (blood pressure ≥ 140/90 mmHg or antihypertensive medication use). Numerous factors contribute to the development of prehypertension and hypertension including age, genetics, obesity, and behavioral factors such as exercise and diet.However, the sleep disorder insomnia is another behavioral factor increasingly implicated with risk of hypertension. Insomnia, the most frequent sleep complaint in adults, is characterized by difficulty falling asleep, trouble maintaining sleep or non-restorative sleep coupled with significant daytime distress or functional impairment. Insomnia is a pervasive sleep disorder associated with decreased quality of life, reduced work productivity, and increased health care costs; it is increasingly identified as a cardiovascular disease risk factor. Lifestyle modifications recommended for pre-hypertension and hypertension do not address sleep. This pilot randomized clinical trial will test the preliminary efficacy of an online cognitive behavioral therapy intervention (N=40) versus an online healthy sleep habits intervention (N=20), to reduce blood pressure in a sample of untreated individuals with insomnia and prehypertension or hypertension. Participants will be followed for 12-weeks post-intervention. Primary outcome measures are systolic blood pressure. Secondary measures include sleep efficiency, insomnia severity, physical and mental function.

Official Title
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Online CBT-I for High Blood Pressure

Conditions
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Insomnia, Hypertension, Prehypertension

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Healthy Sleep Habits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prehypertension or hypertension, insomnia (difficulty getting to sleep, staying asleep and/or early morning awakenings), internet access, current email use, willingness to be randomized to either intervention group, ability to read/write in English. Exclusion Criteria: medication known to alter sleep, sleep disorder (other than insomnia), frequent travel over 2-3 time zones, currently receiving behavioral treatment for insomnia, major depression, anxiety disorders, PTSD or bipolar disorder, >14 alcoholic drinks/week, recreational drug use, prior diagnosis of: epilepsy, dementia/Alzheimer's disease, renal failure requiring dialysis, stroke, secondary hypertension, angina, peripheral artery disease, heart failure, myocardial infarction or cardiac surgery within the past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>online sessions on how behaviors and thoughts that can affect sleep. | Behavioral: Cognitive Behavioral Therapy<br>* 6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep<br>* Other names: CBT-I;|
| Sham Comparator: Healthy Sleep Habits<br>online sessions about healthy sleep practices | Behavioral: Healthy Sleep Habits<br>* 6 weekly, 20 minute online sessions about healthy sleep practices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Systolic blood pressure will be measured at baseline, 8 and 20 weeks | 8 and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index | Insomnia Severity Index (ISI) questionnaire will be measured at baseline, 8 and 20 weeks | 8 and 20 weeks | 
| Changes in Sleep Efficiency | Actigraphy based sleep efficiency will be measured at baseline, 8 and 20 weeks | 8 and 20 weeks | 
| Change in Depressive Symptoms | Depressive symptoms measured at baseline, 8 and 20 weeks | 8 and 20 weeks | 
| Change in mental functioning | Mental function measured at baseline, 8 and 20 weeks | 8 and 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral therapy for insomnia, sleep hygiene