Online CBT-I for High Blood Pressure
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 31, 2016
August 1, 2016
2 years
November 14, 2014
August 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Systolic Blood Pressure
Systolic blood pressure will be measured at baseline, 8 and 20 weeks
8 and 20 weeks
Secondary Outcomes (4)
Change in Insomnia Severity Index
8 and 20 weeks
Changes in Sleep Efficiency
8 and 20 weeks
Change in Depressive Symptoms
8 and 20 weeks
Change in mental functioning
8 and 20 weeks
Study Arms (2)
Cognitive Behavioral Therapy
EXPERIMENTALonline sessions on how behaviors and thoughts that can affect sleep.
Healthy Sleep Habits
SHAM COMPARATORonline sessions about healthy sleep practices
Interventions
6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep
6 weekly, 20 minute online sessions about healthy sleep practices
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- American Heart Associationcollaborator
Study Sites (1)
Emory University
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 14, 2014
First Posted
November 24, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 31, 2016
Record last verified: 2016-08