Cognitive Behavioral Therapy for Sleep Issues from Adverse Childhood Experiences
Trial Summary
What is the purpose of this trial?
The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function. In Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim. In Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants who are currently or recently (within the past month) using anti-hypertensive, lipid-lowering, glucose-controlling, or prescription anti-inflammatory medications, as well as opiates, benzodiazepines, or trazodone. Recent changes to or unstable treatment with prescription medications within the last 6 months are also not allowed.
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-i) for sleep issues from adverse childhood experiences?
Cognitive Behavioral Therapy for Insomnia (CBT-i) is effective for treating insomnia, even when it occurs alongside other medical or psychiatric conditions. Studies show it improves sleep quality and can help reduce symptoms of other mental health issues, making it a promising option for those with sleep problems related to adverse childhood experiences.12345
Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?
How is Cognitive Behavioral Therapy for Insomnia (CBT-I) different from other treatments for sleep issues related to adverse childhood experiences?
CBT-I is unique because it is a non-drug treatment that focuses on changing sleep habits and behaviors through techniques like cognitive therapy, relaxation, and sleep restriction. It is considered the first-line treatment for insomnia, even when it occurs alongside other medical or psychiatric conditions, and can be adapted for use in various settings, including primary care and community environments.1491011
Research Team
Nathaniel Jenkins, PhD
Principal Investigator
Assistant Professor
Eligibility Criteria
This trial is for young adults who have had difficult experiences in childhood, like abuse or neglect, which may affect their sleep and heart health. They should be willing to undergo sleep monitoring at home and tests that measure blood vessel health.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Cohort Study
Participants undergo sleep monitoring and endothelial function assessment to study the impact of sleep quality on vascular health.
Intervention
Participants are randomized to a 6-week behavioral sleep intervention or wait-list control to assess the impact on vascular dysfunction.
Follow-up
Participants are monitored for changes in vascular function and sleep quality post-intervention.
Treatment Details
Interventions
- Cognitive Behavioral Therapy for Insomnia (CBT-i) (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nathaniel Jenkins
Lead Sponsor