InsomniaNCT02848859
Improving Sleep for Healthy Hearts
A study testing Go! to Sleep and General Sleep Education in people with Insomnia and Coronary Heart Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Coronary Heart Disease
- What is being tested?
- Go! to Sleep and General Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet criteria for at least mild insomnia based on the Insomnia Severity Index questionnaire results
- have established coronary disease defined by: a) prior myocardial infarction or a coronary artery revascularization procedure; b) angiographically documented stenosis (>70%) of a major coronary artery; or c) prior ischemic stroke without major functional impairment.
- minimum age of 18 years old.
Who cannot join
- no daily access to a computer with an internet connection
- visual impairment preventing use of a computer
- inability to read English
- severe uncontrolled medical or psychiatric problems
- heart failure with reduced ejection fraction <35%
- high depressive symptoms (PHQ > 15)
Show all 12Show fewer
- drowsy driving
- >3 days per week use of hypnotic medications
- known untreated sleep disordered breathing, narcolepsy, or restless leg syndrome
- shift-workers
- prior exposure to CBT-I treatment
- dialysis patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Womens Hospital
Boston, Massachusetts, 02115
About this study
This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date).
Read the detailed description
For this pilot study, the investigators will recruit up to 30 participants with insomnia and coronary heart disease. Another 30 patients will be recruited from another institution. Patients will be screened with a modified version of the Insomnia Severity Index (ISI), a brief self-report instrument validated for identifying insomnia. The investigators will modify the ISI to include exclusionary criteria. The investigators will randomize participants to 6 weeks of access to web based cognitive behavioral therapy for insomnia (wCBT-I) using an internet based CBT-I program plus education provided through access to the Harvard Sleep Education web site (which provides general sleep education information only) compared to 6 weeks of access to the Harvard Sleep Education web site, followed by access to the web-CBT program (a wait list control group). The investigators will test the hypothesis that use of wCBT-I improves sleep quality and sleep duration as measured by sleep diaries and the ISI. A secondary goal of the study is to assess the recruitment yields, retention and adherence rates.
- Conditions
- Insomnia, Coronary Heart Disease
- Being tested
- Go! to Sleep, General Sleep Education
- Keywords
- cognitive behavioral therapy for insomnia, randomized controlled trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go! to SleepBehavioural
Also called web-based cognitive behavioral therapy
This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.
General Sleep EducationBehavioural
Providing patients information on healthy sleep and habits to promote healthy sleep.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Go! to Sleep | Active comparator | We are using a web-based cognitive behavioral therapy program called Go! to Sleep. Go! to Sleep is an interactive online program developed by specialists in Cleveland Clinic's Wellness Institute and Sleep Disorders Center. The program is a 6 week self-help program that uses cognitive behavioral therapy techniques that have been proven to be effective in decreasing symptoms of insomnia. Receives: Behavioral: Go! to Sleep; Behavioral: General Sleep Education |
| General Sleep Hygiene Education | Placebo comparator | General Sleep Hygiene Education is the first step in the treatment of any sleep disorder. Both arms will have access to a Harvard sleep education web site that provides general information about sleep as well as sleep hygiene. Receives: Behavioral: General Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Insomnia Severity Index score at 6 weeks
It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.
Measured: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Secondary outcomes (6)
Change in sleep duration from baseline to 6 weeks
The investigators will use sleep diaries that participants fill out for 1 week at baseline and at 6 weeks to compare sleep duration between arms as well as at 12 weeks in the treatment arm only to assess duration of treatment effect.
Measured: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks
The investigators will use the Patient Health Questionnaire-8 to measure depressive symptoms
Measured: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks
The investigators will use the Epworth Sleepiness questionnaire to measure sleepiness.
Measured: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Change in blood pressure from baseline to 6 weeks
The investigators will measure seated blood pressure in triplicate and use the average of the latter two readings for blood pressure (taken at baseline and 6 week visits).
Measured: At baseline and at 6 weeks
Change in heart rate from baseline to 6 weeks
The investigators will measure seated heart rate in triplicate and use the average of the latter two readings for heart rate(taken at baseline and 6 week visits).
Measured: At baseline and at 6 weeks
Change in Quality of life at baseline and 6 weeks
The investigators will measure this using the Duke Health Profile, another validated questionnaire to measure quality of life.
Measured: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Susan Redline, Brigham and Women's Hospital
- Investigators
- Susan Redline, MD, MPH, Principal investigator, Brigham and Women's HospitalSogol Javaheri, MD, MA, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848859
- Sponsor's protocol ID
- 2014P000845
- Status last verified
- Feb 2017
- First submitted
- 22 Jul 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep for Healthy Hearts
- ClinicalTrials.gov ID
- NCT02848859
- Acronym / sponsor ID
- 2014P000845
- Conditions
- Insomnia, Coronary Heart Disease
- Keywords
- cognitive behavioral therapy for insomnia, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date).
Detailed description
For this pilot study, the investigators will recruit up to 30 participants with insomnia and coronary heart disease. Another 30 patients will be recruited from another institution. Patients will be screened with a modified version of the Insomnia Severity Index (ISI), a brief self-report instrument validated for identifying insomnia. The investigators will modify the ISI to include exclusionary criteria. The investigators will randomize participants to 6 weeks of access to web based cognitive behavioral therapy for insomnia (wCBT-I) using an internet based CBT-I program plus education provided through access to the Harvard Sleep Education web site (which provides general sleep education information only) compared to 6 weeks of access to the Harvard Sleep Education web site, followed by access to the web-CBT program (a wait list control group). The investigators will test the hypothesis that use of wCBT-I improves sleep quality and sleep duration as measured by sleep diaries and the ISI. A secondary goal of the study is to assess the recruitment yields, retention and adherence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Go! to Sleep | Active comparator | Behavioral: Go! to Sleep, Behavioral: General Sleep EducationWe are using a web-based cognitive behavioral therapy program called Go! to Sleep. Go! to Sleep is an interactive online program developed by specialists in Cleveland Clinic's Wellness Institute and Sleep Disorders Center. The program is a 6 week self-help program that uses cognitive behavioral therapy techniques that have been proven to be effective in decreasing symptoms of insomnia. |
| General Sleep Hygiene Education | Placebo comparator | Behavioral: General Sleep EducationGeneral Sleep Hygiene Education is the first step in the treatment of any sleep disorder. Both arms will have access to a Harvard sleep education web site that provides general information about sleep as well as sleep hygiene. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- meet criteria for at least mild insomnia based on the Insomnia Severity Index questionnaire results
- have established coronary disease defined by: a) prior myocardial infarction or a coronary artery revascularization procedure; b) angiographically documented stenosis (>70%) of a major coronary artery; or c) prior ischemic stroke without major functional impairment.
- minimum age of 18 years old.
Key exclusion criteria (12 listed)
- no daily access to a computer with an internet connection
- visual impairment preventing use of a computer
- inability to read English
- severe uncontrolled medical or psychiatric problems
- heart failure with reduced ejection fraction <35%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go! to SleepAlso: web-based cognitive behavioral therapyThis is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet. | Behavioural | Intervention: Go! to Sleep |
| General Sleep EducationProviding patients information on healthy sleep and habits to promote healthy sleep. | Behavioural | General Sleep Hygiene Education, Intervention: Go! to Sleep |
Primary outcome
Change from baseline Insomnia Severity Index score at 6 weeks
Time frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.
6 secondary outcomes
Change in sleep duration from baseline to 6 weeks
Time frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks
Time frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks
Time frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Change in blood pressure from baseline to 6 weeks
Time frame: At baseline and at 6 weeks
Change in heart rate from baseline to 6 weeks
Time frame: At baseline and at 6 weeks
Change in Quality of life at baseline and 6 weeks
Time frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Redline, MD, MPH principal investigator
Brigham and Women's Hospital
Sogol Javaheri, MD, MA study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go! to Sleep and General Sleep Education in people with Insomnia and Coronary Heart Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Insomnia Severity Index score at 6 weeks (time frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.