Online CBT-I for High Blood Pressure

Hypertension Clinical Trial

Official title:

Online CBT-I for High Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299193
• Other study ID #: IRB00073066
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: August 29, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypertension
• Insomnia
• Prehypertension
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy
6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep
• Healthy Sleep Habits
6 weekly, 20 minute online sessions about healthy sleep practices

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure	Systolic blood pressure will be measured at baseline, 8 and 20 weeks	8 and 20 weeks	No
Secondary	Change in Insomnia Severity Index	Insomnia Severity Index (ISI) questionnaire will be measured at baseline, 8 and 20 weeks	8 and 20 weeks	No
Secondary	Changes in Sleep Efficiency	Actigraphy based sleep efficiency will be measured at baseline, 8 and 20 weeks	8 and 20 weeks	No
Secondary	Change in Depressive Symptoms	Depressive symptoms measured at baseline, 8 and 20 weeks	8 and 20 weeks	No
Secondary	Change in mental functioning	Mental function measured at baseline, 8 and 20 weeks	8 and 20 weeks	No