NCT02299193

Online CBT-I for High Blood Pressure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Hypertension
• Prehypertension
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep
BEHAVIORAL	Healthy Sleep Habits	6 weekly, 20 minute online sessions about healthy sleep practices

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-11-24
• Last updated: 2016-08-31

Locations

1 site across 1 country: United States