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.
What safety data exists for CBT-I?Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe and effective, with no risk of harm associated with sleeping medications. It is recommended as the first-line treatment for chronic insomnia due to its efficacy and lack of adverse effects compared to pharmacologic approaches. The therapy is effective for both primary insomnia and insomnia comorbid with other medical and psychiatric conditions, with moderate to large treatment effects reported. However, more randomized, controlled studies are needed to further validate its efficacy in specific populations.147910
Is Cognitive Behavioral Therapy for Insomnia (CBT-i) a promising treatment for sleep issues from adverse childhood experiences?Yes, Cognitive Behavioral Therapy for Insomnia (CBT-i) is a promising treatment. It is considered the first-line treatment for insomnia and has shown effectiveness in improving sleep, even when insomnia is linked to other medical or psychological issues. CBT-i can help people with sleep problems, including those with a history of adverse childhood experiences, by improving sleep quality and reducing insomnia symptoms.1281011
Do I need to stop taking my current medications to join the trial?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. Additionally, recent changes to or unstable treatment with prescription medications within the last 6 months are also exclusion criteria.
What data supports the idea that Cognitive Behavioral Therapy for Sleep Issues from Adverse Childhood Experiences is an effective treatment?The available research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for treating sleep issues. It is considered the first choice for treating insomnia, even when it occurs alongside other chronic disorders. Studies have shown that CBT-I helps improve sleep quality and reduces the need for medication. It has also been effective for people with psychiatric conditions, helping to reduce both insomnia and other symptoms. While more research is needed, especially in specific medical and psychiatric conditions, the data suggests that CBT-I is a promising treatment for improving sleep and overall well-being.135610
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
I am between 18 and 29 years old.
Exclusion Criteria
I am being treated for a sleep disorder or have been diagnosed with restless leg syndrome, hypersomnia, parasomnia, narcolepsy, or obstructive sleep apnea.
I have a diagnosed neurological disorder.
I have been diagnosed with an autoimmune or chronic inflammatory condition.
I have been diagnosed with cancer.
I have a history of heart, lung, kidney disease, or diabetes.
I have used opiates, benzodiazepines, or trazodone in the last month.
I am currently using hormone therapy.
I am currently pregnant, breastfeeding, or have a child under 2 years old at home.
I likely have sleep apnea, shown by my sleep test results or low oxygen levels at night.
Treatment Details
The study looks at how poor sleep might link early life stress to problems with blood vessels. It involves two parts: first measuring participants' sleep and vessel health, then seeing if improving sleep through therapy can help their vessels function better.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy for Insomnia (CBT-i)Experimental Treatment1 Intervention
Group II: Waitlist ControlActive Control1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
Integrative Laboratory of Applied Physiology and Lifestyle MedicineIowa City, IA
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Who is running the clinical trial?
Nathaniel JenkinsLead Sponsor
References
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]Insomnia is a pervasive problem for many patients suffering from medical and psychiatric conditions. Even when the comorbid disorders are successfully treated, insomnia often fails to remit. In addition to compromising quality of life, untreated insomnia may also aggravate and complicate recovery from the comorbid disease. Cognitive behavior therapy for insomnia (CBT-I) has an established efficacy for primary insomnia, but less is known about its efficacy for insomnia occurring in the context of medical and psychiatric conditions. The purpose of this article is to present a rationale for using CBT-I in medical and psychiatric disorders, review the extant outcome literature, highlight considerations for adapting CBT-I procedures in specific populations, and suggest directions for future research. Outcome studies were identified for CBT-I in mixed medical and psychiatric conditions, cancer, chronic pain, HIV, depression, posttraumatic stress disorder, and alcoholism. Other disorders discussed include: bipolar disorder, eating disorders, generalized anxiety, and obsessive compulsive disorder. The available data demonstrate moderate to large treatment effects (Cohen's d, range=0.35-2.2) and indicate that CBT-I is a promising treatment for individuals with medical and psychiatric comorbidity. Although the literature reviewed here is limited by a paucity of randomized, controlled studies, the available data suggest that by improving sleep, CBT-I might also indirectly improve medical and psychological endpoints. This review underscores the need for future research to test the efficacy of adaptations of CBT-I to disease specific conditions and symptoms.
Adverse childhood experiences associated with sleep in primary insomnia. [2007]The objectives were to explore the association between self-reported adverse childhood experiences (ACE) and sleep in adults suffering from primary insomnia and to examine the impact of presleep stress on this relationship. Fifty-nine patients with primary insomnia, aged 21-55 years, were administered the Childhood Trauma Questionnaire (CTQ) and then divided into two groups according to the achieved scores: with moderate/severe or low/no reports of ACE. The participants spent three consecutive nights in the sleep laboratory in order to record polysomnographic and actigraphic sleep parameters. A stress induction technique was administered by activating negative autobiographical memories immediately before sleep in the second or third night. Results show that 46% of the insomniac patients reported moderate to severe ACE. This group exhibited a significantly greater number of awakenings and more movement arousals compared to patients with low or no reports of ACE. Actigraphic data also indicated more disturbed sleep and increased nocturnal activity for the high-ACE group. On the other hand, no specific group differences were found with regard to stress condition. The results support the assumption that it is possible to identify a subgroup among patients with primary insomnia who has experienced severe maltreatment in childhood and adolescence. This subgroup appears to differ in several sleep parameters, indicating a more disturbed sleep compared to primary insomniacs with low or no reports of ACE. With regard to sleep-disturbing nightly patterns of arousal, parallels between individuals with high ACE and trauma victims as well as post-traumatic stress disorder-patients suggest themselves.
[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018]The effectiveness of cognitive behavioural therapy for insomnia (cbt-i) has been demonstrated in randomised controlled trials (rct's) with primary insomnia patients and, more recently, with comorbid insomnia patients. The clinical impact of the treatment is mainly on sleep quality and the use of medication and to a lesser extent on daytime functioning. So far there have been very few studies of the effectiveness of cbt-i in clinical settings.
New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]Insomnia is the most common sleep disorder. Psychological, behavioral, and biological factors are implicated in the development and maintenance of insomnia as a disorder, although the etiology of insomnia remains under investigation, as it is still not fully understood. Cognitive behavioral therapy for insomnia (CBTI) is a treatment for insomnia that is grounded in the science of behavior change, psychological theories, and the science of sleep. There is strong empirical evidence that CBTI is effective. Recognition of CBTI as the first-line treatment for chronic insomnia (National Institutes of Health consensus, British Medical Association) was based largely on evidence of its efficacy in primary insomnia. The aim of this article is to provide background information and review recent developments in CBTI, focusing on three domains: promising data on the use of CBTI when insomnia is experienced in the presence of comorbid conditions, new data on the use of CBTI as maintenance therapy, and emerging data on the delivery of CBTI through the use of technology and in primary care settings.
Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]To test the efficacy of cogntive-behavioral therapy for insomnia (CBT-I) as a supplement treatment for psychiatric outpatients. Comorbid insomnia is prevalent among individuals with varied psychiatric disorders and evidence indicates that CBT-I may be effective for reducing insomnia and other psychiatric symptoms.
Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for persistent insomnia. The purpose of this study was to examine the effectiveness of and response patterns to CBT-I among daytime and shift workers with insomnia over a 24-month follow-up in occupational health services (OHS).
Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]Because psychological approaches are likely to produce sustained benefits without the risk for tolerance or adverse effects associated with pharmacologic approaches, cognitive behavioral therapy for insomnia (CBT-i) is now commonly recommended as first-line treatment for chronic insomnia.
A systematic review of cognitive behavioral therapy for insomnia implemented in primary care and community settings. [2019]The advent of stepped-care and the need to disseminate cognitive behavioral therapy for insomnia (CBT-I) has led to novel interventions, which capitalize on non-specialist venues and/or health personnel. However, the translatability of these CBT-I programs into practice is unknown. This review evaluates the current state of CBT-I programs that are directly implemented in primary care and/or community settings. A literature search was conducted through major electronic databases (N = 840) and through snowballing (n = 8). After removing duplicates, 104 full-texts were extracted and evaluated against our initial inclusion criteria. Twelve studies including data from 1625 participants were subsequently evaluated for its study design and methodological quality. CBT-I program components varied across studies and included cognitive therapy (n = 6), relaxation (n = 7), sleep restriction therapy (n = 9), stimulus control therapy (n = 11) and sleep psychoeducation (n = 12). The respective interventions produced small to moderate post-treatment weighted effect sizes for the Insomnia Severity Index (0.40), Pittsburgh Sleep Quality Index (0.37), sleep efficiency (0.38), sleep onset latency (0.38), and wake time after sleep onset (0.46) but total sleep time (0.10) did not reach statistical significance. While non-specialist community settings can potentially address the demands for CBT-I across clinical contexts, intervention heterogeneity precluded the full impact of the 12 CBT-I programs to be evaluated.
"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). [2021]Cognitive behavioral therapy for insomnia (CBT-I) provides safe and effective insomnia care without the risk of harm associated with sleeping medications. Unfortunately, few patients with insomnia engage with CBT-I, with most using sedative hypnotics instead. This study conducted focus groups with patients with insomnia who were treated with sleeping medication, including older adults, women, and patients with chronic pain. The goal was to explore the perspectives of high-risk, CBT-I naïve patients on increasing access and engagement with CBT-I.
We know CBT-I works, now what? [2022]Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be efficacious and now is considered the first-line treatment for insomnia for both uncomplicated insomnia and insomnia that occurs comorbidly with other chronic disorders (comorbid insomnia). The purposes of this review are to provide a comprehensive summary of the efficacy data (for example, efficacy overall and by clinical and demographic considerations and by CBT-I formulation) and to discuss the future of CBT-I (for example, what next steps should be taken in terms of research, dissemination, implementation, and practice).
Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]: Cognitive behavioral treatment for insomnia (CBT-I) is the first line of treatment for insomnia. However, the expanded use of CBT-I is limited by the number of specialty-trained clinicians in addition to the duration and cost of individual treatment sessions. One viable option is a single-session educational group format delivered by a trained health educator.