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Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease (STOPCVD)

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ClinicalTrials.gov Identifier: NCT04059302
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Megan Petrov, Arizona State University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Insomnia Chronic Subclinical Disease and/or Syndrome Behavioral: Internet-delivered Cognitive Behavioral Therapy for Insomnia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The ultra sound technician that will be evaluating the primary outcome measures will be blinded to participant condition.
Primary Purpose: Treatment
Official Title: Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : August 30, 2021

Arm Intervention/treatment
Experimental: Online CBT-I
Fully-automated, internet-delivered cognitive behavioral therapy for insomnia program that consists of 6 therapy cores delivered weekly over 6 weeks.
Behavioral: Internet-delivered Cognitive Behavioral Therapy for Insomnia
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.

No Intervention: Wait-List Control
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Change in Baseline to Post-Treatment Indices of Cardiac Structure via Resting Echocardiography Imaging [ Time Frame: Baseline; Post-treatment: 7 weeks after treatment initiation ]
    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.

  3. Change in Baseline to Post-Treatment Central Augmentation Index [ Time Frame: Baseline; Post-treatment: 7 weeks after treatment initiation ]
    The difference between early and late pressure peaks divided by pulse pressure

  4. Change in Baseline to Post-Treatment Central Systolic blood pressure [ Time Frame: Baseline; Post-treatment: 7 weeks after treatment initiation ]
    Blood pressure at the aorta close to the heart

  5. 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 ]
    Change in the differences between central systolic and central diastolic pressures



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

A. The patient reports one or more of the following:

  1. Difficulty initiating sleep.
  2. Difficulty maintaining sleep.
  3. Waking up earlier than desired.

B. The patient reports, one or more of the following related to the nighttime sleep difficulty:

  1. Fatigue/malaise.
  2. Attention, concentration, or memory impairment.
  3. Impaired social, family, occupational, or academic performance.
  4. Mood disturbance/irritability.
  5. Daytime sleepiness.
  6. Behavioral problems (e.g., hyperactivity, impulsivity, aggression).
  7. Reduced motivation/energy/initiative.
  8. Proneness for errors/accidents.
  9. 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.

D. The sleep disturbance and associated daytime symptoms occur at least three times per week.

E. 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059302


Contacts
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Contact: Megan E Petrov, PhD 16024962297 megan.petrov@asu.edu

Locations
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United States, Arizona
Arizona State University Recruiting
Phoenix, Arizona, United States, 85004
Contact: Megan E Petrov, PhD    602-496-2297    megan.petrov@asu.edu   
Sponsors and Collaborators
Megan Petrov
Investigators
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Principal Investigator: Megan E Petrov, PhD Arizona State University
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Responsible Party: Megan Petrov, Assistant Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT04059302    
Other Study ID Numbers: STUDY00004470
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders