Online CBT-I for High Blood Pressure
Primary Purpose
Hypertension, Prehypertension, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Healthy Sleep Habits
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension focused on measuring cognitive behavioral therapy for insomnia, sleep hygiene
Eligibility Criteria
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
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Cognitive Behavioral Therapy
Healthy Sleep Habits
Arm Description
online sessions on how behaviors and thoughts that can affect sleep.
online sessions about healthy sleep practices
Outcomes
Primary Outcome Measures
Change in Systolic Blood Pressure
Systolic blood pressure will be measured at baseline, 8 and 20 weeks
Secondary Outcome Measures
Change in Insomnia Severity Index
Insomnia Severity Index (ISI) questionnaire will be measured at baseline, 8 and 20 weeks
Changes in Sleep Efficiency
Actigraphy based sleep efficiency will be measured at baseline, 8 and 20 weeks
Change in Depressive Symptoms
Depressive symptoms measured at baseline, 8 and 20 weeks
Change in mental functioning
Mental function measured at baseline, 8 and 20 weeks
Full Information
NCT ID
NCT02299193
First Posted
November 14, 2014
Last Updated
August 29, 2016
Sponsor
Emory University
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT02299193
Brief Title
Online CBT-I for High Blood Pressure
Official Title
Online CBT-I for High Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
American Heart Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Prehypertension, Insomnia
Keywords
cognitive behavioral therapy for insomnia, sleep hygiene
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
online sessions on how behaviors and thoughts that can affect sleep.
Arm Title
Healthy Sleep Habits
Arm Type
Sham Comparator
Arm Description
online sessions about healthy sleep practices
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT-I
Intervention Description
6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep
Intervention Type
Behavioral
Intervention Name(s)
Healthy Sleep Habits
Intervention Description
6 weekly, 20 minute online sessions about healthy sleep practices
Primary Outcome Measure Information:
Title
Change in Systolic Blood Pressure
Description
Systolic blood pressure will be measured at baseline, 8 and 20 weeks
Time Frame
8 and 20 weeks
Secondary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
Insomnia Severity Index (ISI) questionnaire will be measured at baseline, 8 and 20 weeks
Time Frame
8 and 20 weeks
Title
Changes in Sleep Efficiency
Description
Actigraphy based sleep efficiency will be measured at baseline, 8 and 20 weeks
Time Frame
8 and 20 weeks
Title
Change in Depressive Symptoms
Description
Depressive symptoms measured at baseline, 8 and 20 weeks
Time Frame
8 and 20 weeks
Title
Change in mental functioning
Description
Mental function measured at baseline, 8 and 20 weeks
Time Frame
8 and 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
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Online CBT-I for High Blood Pressure
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