Skip to main content
OpenTrials
Completed

NCT Number: NCT02299193

Online CBT-I for High Blood Pressure

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep

Other names: CBT-I

Healthy Sleep Habits

Behavioral

6 weekly, 20 minute online sessions about healthy sleep practices

Primary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: 8 and 20 weeks

    Systolic blood pressure will be measured at baseline, 8 and 20 weeks

Secondary outcomes

  1. Change in Insomnia Severity Index

    Time frame: 8 and 20 weeks

    Insomnia Severity Index (ISI) questionnaire will be measured at baseline, 8 and 20 weeks

  2. Changes in Sleep Efficiency

    Time frame: 8 and 20 weeks

    Actigraphy based sleep efficiency will be measured at baseline, 8 and 20 weeks

  3. Change in Depressive Symptoms

    Time frame: 8 and 20 weeks

    Depressive symptoms measured at baseline, 8 and 20 weeks

  4. Change in mental functioning

    Time frame: 8 and 20 weeks

    Mental function measured at baseline, 8 and 20 weeks

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2014
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.