General Sleep Education Intervention for Cardiovascular Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Greater Los Angeles Healthcare System, North Hills, CA
Cardiovascular Diseases+6 More
General Sleep Education Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This pilot randomized controlled trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by one of two non-medication sleep education and treatment programs for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.

Eligible Conditions

  • Cardiovascular Diseases
  • Post Traumatic Stress Disorder (PTSD)
  • Insomnia
  • Metabolic Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 6 Secondary · Reporting Duration: Change from baseline to 1 week after completion of sleep intervention

Week 1
24-hr ambulatory blood pressure monitoring (ABPM) blood pressure variability
24-hr ambulatory blood pressure monitoring (ABPM) change in blood pressure day to night
24-hr ambulatory blood pressure monitoring (ABPM) systolic/diastolic loads
Actigraphy
Body Mass Index (BMI)
Central adiposity
Consensus sleep diary questionnaire
Dyslipidemia
Homeostatic Model Assessment of Insulin Resistance (HOMA)
PTSD Checklist for DSM-5 (PCL-5)
WHOQOL-BREF questionnaire
Month 6
Hemoglobin A1c (HbA1c)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

General Sleep Education Intervention
1 of 2
Behavioral Sleep Education Intervention
1 of 2
Experimental Treatment

167 Total Participants · 2 Treatment Groups

Primary Treatment: General Sleep Education Intervention · No Placebo Group · N/A

General Sleep Education Intervention
Behavioral
Experimental Group · 1 Intervention: General Sleep Education Intervention · Intervention Types: Behavioral
Behavioral Sleep Education Intervention
Behavioral
Experimental Group · 1 Intervention: Behavioral Sleep Education Intervention · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 1 week after completion of sleep intervention
Closest Location: VA Greater Los Angeles Healthcare System · North Hills, CA
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2002First Recorded Clinical Trial
4 TrialsResearching Cardiovascular Diseases
41 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentFED
1,457 Previous Clinical Trials
2,747,512 Total Patients Enrolled
35 Trials studying Cardiovascular Diseases
81,310 Patients Enrolled for Cardiovascular Diseases
University of California, Los AngelesLead Sponsor
1,381 Previous Clinical Trials
6,520,980 Total Patients Enrolled
17 Trials studying Cardiovascular Diseases
12,723 Patients Enrolled for Cardiovascular Diseases

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You received care from a VHA facility in the past year.
You have a diagnosis of PTSD.
You have insomnia disorder.
You live within a 50-mile radius of the VA Sepulveda Ambulatory Care Center.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.