Insomnia ChronicSTOPCVDNCT04059302
Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease
A study testing Internet-delivered Cognitive Behavioral Therapy for Insomnia in people with Insomnia Chronic and Subclinical Disease and/or Syndrome, run by Megan Petrov at 1 site in United States.
Trial summary
This randomized controlled trial will test the efficacy of online cognitive-behavioral therapy for insomnia (CBT-I) to improve markers of subclinical cardiovascular disease risk among middle aged adults (40-64 years) with chronic insomnia who are at moderate-to-high risk for cardiovascular disease. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Insomnia Chronic, Subclinical Disease and/or Syndrome
- What is being tested?
- Internet-delivered Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 15 Jul 2021
- 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 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants must be 40-64 years of age, able to understand English, score 10 or higher on the Insomnia Severity Index, >30 minutes nocturnal wakefulness (sleep onset latency or wake after sleep onset) for at least 3 nights per week, meet International Classification of Sleep Disorders-III [ISCD-3] diagnostic criteria for an insomnia disorder (see below), have a family history of cardiovascular disease, and screen positive for impaired FMD (< 7% difference between brachial artery diameter before and after occlusion).
- ICSD-3 criteria for insomnia disorder:
- The patient reports one or more of the following:
- Difficulty initiating sleep.
- Difficulty maintaining sleep.
- Waking up earlier than desired.
Show all 18Show fewer
- The patient reports, one or more of the following related to the nighttime sleep difficulty:
- Fatigue/malaise.
- Attention, concentration, or memory impairment.
- Impaired social, family, occupational, or academic performance.
- Mood disturbance/irritability.
- Daytime sleepiness.
- Behavioral problems (e.g., hyperactivity, impulsivity, aggression).
- Reduced motivation/energy/initiative.
- Proneness for errors/accidents.
- Concerns about or dissatisfaction with sleep. C. The reported sleep/wake complaints cannot be explained purely by inadequate opportunity (i.e., enough time is allotted for sleep) or inadequate circumstances (i.e., the environment is safe, dark, quiet, and comfortable) for sleep.
- The sleep disturbance and associated daytime symptoms occur at least three times per week.
- The sleep disturbance and associated daytime symptoms have been present for at least three months F. The sleep/wake difficulty is not better explained by another sleep disorder.
Who cannot join
- Participant will be excluded if they screen positive using retrospective questionnaires for other sleep disorders (see appendix of questionnaires), are involved in shift work, have a personal history of cardiovascular disease (i.e., myocardial infarction, atrial fibrillation, stroke, transient ischemic attack, diabetes, peripheral vascular disease), untreated Stage 2 hypertension (i.e., systolic blood pressure ≥ 160; diastolic blood pressure ≥ 100), current or diagnosis of psychiatric disorder within the past six months (including psychotic, mood, and anxiety disorders), start of psychotherapy within the past 6 months, clinically significant depressive symptoms as measured by a score of 10 or greater on the Center for Epidemiologic Studies Depression (CESD)-10 Revised scale, current or previous history of behavioral interventions for insomnia, currently smoking or using other nicotine products, excessive use of caffeine (>4 cups/day) or alcohol (>2 drinks/day), current and frequent use (2+ per week) of sleep medications, and engaging in vigorous exercise 75+ minutes/week. Women who are peri-menopausal, pregnant, breastfeeding, or trying to become pregnant will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial will test the efficacy of online cognitive-behavioral therapy for insomnia (CBT-I) to improve markers of subclinical cardiovascular disease risk among middle aged adults (40-64 years) with chronic insomnia who are at moderate-to-high risk for cardiovascular disease. Multiple trials have revealed face to face and digital CBT-I improves insomnia symptoms and associated daytime functioning. However, CBT-I has not been tested as a primary prevention intervention to reduce risk for CVD. Mid-life adults are a high-risk group for the emergence of CVD with detrimental consequences pervading into older adulthood including reduced quality of life and greater health care costs. The investigators will evaluate whether online CBT-I affects vascular and cardiac function and structure at post-treatment and 8-week follow-up in a community-based sample.
Hypothesis 1: Online CBT-I will improve indices of cardiovascular function and structure compared to a wait-list control group at post-treatment.
Hypothesis 2: Improvements in indices of cardiovascular function and structure will be maintained at 8-week follow-up in the online CBT-I group.
Read the detailed description
In this randomized controlled trial, comparing internet-delivered cognitive behavioral therapy for insomnia (CBT-I) to a wait-list control group on pre-post trial changes in indices of cardiovascular structure and function among community-based middle-aged adults with insomnia and moderate-to-high risk for cardiovascular disease, the investigators will recruit and enroll 38 participants.
Initial screening will be conducted with an online survey. If they meet preliminary study criteria, then research staff will contact the participant to schedule an in-person, baseline assessment visit. They will be instructed that they must meet fasting requirements prior to this visit to obtain accurate cardiovascular physiology measurement.
At the baseline assessment visit, the participants will undergo the informed consent process, complete questionnaire inquiring about medical, mental, and sleep health history, undergo a brief physical (vital signs, height, weight), and complete cardiovascular physiology assessment. If the participants remain eligible after these assessment, then the pariticpants will receive orientation on how to complete an online sleep diary while simultaneously wearing a wrist actigraph to track sleep and activity for the next 7 nights. This procedure is for baseline assessment. It will not be used to further screen participants.
Once the participants complete this baseline sleep assessment, then they will randomly assigned to either immediate treatment with internet delivered CBT-I or a wait-list control group. The intervention group will receive an email with their own personal subscription to the online CBT-I program. Both groups will continue to wear the wrist actigraph for the duration of the trial. The immediate CBT-I group will complete sleep diaries within the online therapy program throughout the trial, whereas the wait-list control group will complete email-delivered, online sleep diaries from study staff throughout the trial.
The online Cognitive Behavioral Therapy for Insomnia intervention is based in a standardized, manualized treatment designed to decrease sleep-inhibiting cognitions and behaviors, and to alter sleep-wake schedules. This fully automated therapy tailors its program features according to sleep diary data inputs. The therapy will consist of CBTI-I components: stimulus control therapy, sleep restriction therapy, cognitive therapy, and sleep education. The first week of treatment will solely focus on sleep education and completion of sleep logs.
Upon completion of the treatment period, all participants will complete one more week of sleep diaries and wearing the wrist actigraph. The participants also will be scheduled to attend their post-treatment/trial in-person visit for assessment and to return the actigraph. Participants will complete questionnaires and undergo cardiovascular physiological assessment.
After this post-treatment visit, the wait-list control group will receive their subscription of the internet-delivered CBT-I program.
Participants randomly assigned to immediate internet delivered CBT-I will be scheduled for an 8-week follow-up visit during which they will once again complete outcome questionnaires and cardiovascular physiological assessment.
- Being tested
- Internet-delivered Cognitive Behavioral Therapy for Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cognitive Behavioral Therapy for InsomniaBehavioural
The therapy consists of 6 modules or 'cores' that are introduced on a weekly basis. The cores are designed to decrease sleep-inhibiting cognitions and behaviors, and to alter sleep-wake schedules.
| Study group | Role | What they receive |
|---|---|---|
| Online CBT-I | Experimental | Fully-automated, internet-delivered cognitive behavioral therapy for insomnia program that consists of 6 therapy cores delivered weekly over 6 weeks. Receives: Behavioral: Internet-delivered Cognitive Behavioral Therapy for Insomnia |
| Wait-List Control | No intervention | Wait-list control group will receive no intervention until after the trial period is completed. During the trial period they will complete all study assessments, but receive no active treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline to Post-Treatment endothelial-dependent dilation of the brachial artery (FMD)
A non-invasive assessment of the ability of the brachial (upper arm) artery to dilate in response to an increase in blood flow, and is assessed using ultrasound.
Measured: Baseline; Post-treatment: 7 weeks after treatment initiation
Secondary outcomes (5)
Change in baseline to post-treatment carotid-femoral pulse wave velocity (a measure of aortic stiffness)
Pulse wave velocity = distance/time in m/s. Distance is 80% of the distance measured by tape measure between the two sites assessed. Time is the pulse wave travel time between common carotid and common femoral arteries.
Measured: Baseline; Post-treatment: 7 weeks after treatment initiation
Change in Baseline to Post-Treatment Indices of Cardiac Structure via Resting Echocardiography Imaging
The ultrasound probe from the Terason 3000+ will then be used to capture standard parasternal short-axis, long-axis, apical and sub-sternal views of the heart. . Briefly, left ventricular mass and thickness, ejection fraction, left ventricular diastolic function, and left atrial volume index will be calculated.
Measured: Baseline; Post-treatment: 7 weeks after treatment initiation
Change in Baseline to Post-Treatment Central Augmentation Index
The difference between early and late pressure peaks divided by pulse pressure
Measured: Baseline; Post-treatment: 7 weeks after treatment initiation
Change in Baseline to Post-Treatment Central Systolic blood pressure
Blood pressure at the aorta close to the heart
Measured: Baseline; Post-treatment: 7 weeks after treatment initiation
Change in Baseline to Post-Treatment Central Pulse Pressure
Change in the differences between central systolic and central diastolic pressures
Measured: Baseline; Post-treatment: one week after treatment completion; Follow-up for experimental group only: 8 weeks after post-treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start20 Sep 2019
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Why it stopped: Intervention services were suspended and then unavailable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Megan Petrov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Megan Petrov, Arizona State University
- Investigators
- Megan E Petrov, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059302
- Sponsor's protocol ID
- STUDY00004470
- Acronym
- STOPCVD
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2019
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04059302
- Acronym / sponsor ID
- STOPCVD / STUDY00004470
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intervention services were suspended and then unavailable.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Megan PetrovUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 16 Aug 2019 (actual)
- 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 randomized controlled trial will test the efficacy of online cognitive-behavioral therapy for insomnia (CBT-I) to improve markers of subclinical cardiovascular disease risk among middle aged adults (40-64 years) with chronic insomnia who are at moderate-to-high risk for cardiovascular disease. Multiple trials have revealed face to face and digital CBT-I improves insomnia symptoms and associated daytime functioning. However, CBT-I has not been tested as a primary prevention intervention to reduce risk for CVD. Mid-life adults are a high-risk group for the emergence of CVD with detrimental consequences pervading into older adulthood including reduced quality of life and greater health care costs. The investigators will evaluate whether online CBT-I affects vascular and cardiac function and structure at post-treatment and 8-week follow-up in a community-based sample.
Hypothesis 1: Online CBT-I will improve indices of cardiovascular function and structure compared to a wait-list control group at post-treatment.
Hypothesis 2: Improvements in indices of cardiovascular function and structure will be maintained at 8-week follow-up in the online CBT-I group.
Detailed description
In this randomized controlled trial, comparing internet-delivered cognitive behavioral therapy for insomnia (CBT-I) to a wait-list control group on pre-post trial changes in indices of cardiovascular structure and function among community-based middle-aged adults with insomnia and moderate-to-high risk for cardiovascular disease, the investigators will recruit and enroll 38 participants.
Initial screening will be conducted with an online survey. If they meet preliminary study criteria, then research staff will contact the participant to schedule an in-person, baseline assessment visit. They will be instructed that they must meet fasting requirements prior to this visit to obtain accurate cardiovascular physiology measurement.
At the baseline assessment visit, the participants will undergo the informed consent process, complete questionnaire inquiring about medical, mental, and sleep health history, undergo a brief physical (vital signs, height, weight), and complete cardiovascular physiology assessment. If the participants remain eligible after these assessment, then the pariticpants will receive orientation on how to complete an online sleep diary while simultaneously wearing a wrist actigraph to track sleep and activity for the next 7 nights. This procedure is for baseline assessment. It will not be used to further screen participants.
Once the participants complete this baseline sleep assessment, then they will randomly assigned to either immediate treatment with internet delivered CBT-I or a wait-list control group. The intervention group will receive an email with their own personal subscription to the online CBT-I program. Both groups will continue to wear the wrist actigraph for the duration of the trial. The immediate CBT-I group will complete sleep diaries within the online therapy program throughout the trial, whereas the wait-list control group will complete email-delivered, online sleep diaries from study staff throughout the trial.
The online Cognitive Behavioral Therapy for Insomnia intervention is based in a standardized, manualized treatment designed to decrease sleep-inhibiting cognitions and behaviors, and to alter sleep-wake schedules. This fully automated therapy tailors its program features according to sleep diary data inputs. The therapy will consist of CBTI-I components: stimulus control therapy, sleep restriction therapy, cognitive therapy, and sleep education. The first week of treatment will solely focus on sleep education and completion of sleep logs.
Upon completion of the treatment period, all participants will complete one more week of sleep diaries and wearing the wrist actigraph. The participants also will be scheduled to attend their post-treatment/trial in-person visit for assessment and to return the actigraph. Participants will complete questionnaires and undergo cardiovascular physiological assessment.
After this post-treatment visit, the wait-list control group will receive their subscription of the internet-delivered CBT-I program.
Participants randomly assigned to immediate internet delivered CBT-I will be scheduled for an 8-week follow-up visit during which they will once again complete outcome questionnaires and cardiovascular physiological assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online CBT-I | Experimental | Behavioral: Internet-delivered Cognitive Behavioral Therapy for InsomniaFully-automated, internet-delivered cognitive behavioral therapy for insomnia program that consists of 6 therapy cores delivered weekly over 6 weeks. |
| Wait-List Control | No intervention | –Wait-list control group will receive no intervention until after the trial period is completed. During the trial period they will complete all study assessments, but receive no active treatment. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- All participants must be 40-64 years of age, able to understand English, score 10 or higher on the Insomnia Severity Index, >30 minutes nocturnal wakefulness (sleep onset latency or wake after sleep onset) for at least 3 nights per week, meet International Classification of Sleep Disorders-III [ISCD-3] diagnostic criteria for an insomnia disorder (see below), have a family history of cardiovascular disease, and screen positive for impaired FMD (< 7% difference between brachial artery diameter before and after occlusion).
- The patient reports one or more of the following:
- Difficulty initiating sleep.
- Difficulty maintaining sleep.
- Waking up earlier than desired.
Key exclusion criteria (1 listed)
- Participant will be excluded if they screen positive using retrospective questionnaires for other sleep disorders (see appendix of questionnaires), are involved in shift work, have a personal history of cardiovascular disease (i.e., myocardial infarction, atrial fibrillation, stroke, transient ischemic attack, diabetes, peripheral vascular disease), untreated Stage 2 hypertension (i.e., systolic blood pressure ≥ 160; diastolic blood pressure ≥ 100), current or diagnosis of psychiatric disorder within the past six months (including psychotic, mood, and anxiety disorders), start of psychotherapy within the past 6 months, clinically significant depressive symptoms as measured by a score of 10 or greater on the Center for Epidemiologic Studies Depression (CESD)-10 Revised scale, current or previous history of behavioral interventions for insomnia, currently smoking or using other nicotine products, excessive use of caffeine (>4 cups/day) or alcohol (>2 drinks/day), current and frequent use (2+ per week) of sleep medications, and engaging in vigorous exercise 75+ minutes/week. Women who are peri-menopausal, pregnant, breastfeeding, or trying to become pregnant will also be excluded.
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 |
|---|---|---|
| Internet-delivered Cognitive Behavioral Therapy for InsomniaThe therapy consists of 6 modules or 'cores' that are introduced on a weekly basis. The cores are designed to decrease sleep-inhibiting cognitions and behaviors, and to alter sleep-wake schedules. | Behavioural | Online CBT-I |
Primary outcome
Change in Baseline to Post-Treatment endothelial-dependent dilation of the brachial artery (FMD)
Time frame: Baseline; Post-treatment: 7 weeks after treatment initiation
A non-invasive assessment of the ability of the brachial (upper arm) artery to dilate in response to an increase in blood flow, and is assessed using ultrasound.
5 secondary outcomes
Change in baseline to post-treatment carotid-femoral pulse wave velocity (a measure of aortic stiffness)
Time frame: Baseline; Post-treatment: 7 weeks after treatment initiation
Change in Baseline to Post-Treatment Indices of Cardiac Structure via Resting Echocardiography Imaging
Time frame: Baseline; Post-treatment: 7 weeks after treatment initiation
Change in Baseline to Post-Treatment Central Augmentation Index
Time frame: Baseline; Post-treatment: 7 weeks after treatment initiation
Change in Baseline to Post-Treatment Central Systolic blood pressure
Time frame: Baseline; Post-treatment: 7 weeks after treatment initiation
Change in Baseline to Post-Treatment Central Pulse Pressure
Time frame: Baseline; Post-treatment: one week after treatment completion; Follow-up for experimental group only: 8 weeks after post-treatment visit
Results and safety
The study was stopped early (reason given: Intervention services were suspended and then unavailable.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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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.
Megan E Petrov, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Cognitive Behavioral Therapy for Insomnia in people with Insomnia Chronic and Subclinical Disease and/or Syndrome, run by Megan Petrov 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 18 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Jul 2023. 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. 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 was stopped early (reason given: Intervention services were suspended and then unavailable.). Results are not available in the source record.
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 in Baseline to Post-Treatment endothelial-dependent dilation of the brachial artery (FMD) (time frame: Baseline; Post-treatment: 7 weeks after treatment initiation). 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 19 Jul 2023.