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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Experimental | online sessions on how behaviors and thoughts that can affect sleep. |
|
| Healthy Sleep Habits | Sham Comparator | online sessions about healthy sleep practices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D058246 | Prehypertension |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000070263 | Sleep Hygiene |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Healthy Sleep Habits | Behavioral | 6 weekly, 20 minute online sessions about healthy sleep practices |
|
| 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 |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |