CompletedNCT07927335ClinicalTrials.gov record

ACEs, CBT-i, and Cardiovascular Health

Adverse Childhood Experiences · Sleep Disruption · Vascular Dysfunction · Endothelial Function (FMD)

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 29 years
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 16 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Our accumulating evidence indicates that young adults that have been exposed to Adverse Childhood Experiences (ACEs) display both impaired vascular function, poorer cardiometabolic health, and poor sleep. Our data indicate that sleep impairments may mediate the link between ACEs and vascular and metabolic dysfunction. The primary purpose of this project is to determine if cognitive behavioral therapy for insomnia (CBT-i) is feasible for improving sleep in young adults who have been exposed to ACEs and who have poor sleep. Secondarily, we will collect preliminary efficacy data to determine whether CBT-i can improve vascular and cardiometabolic health in this population, as well as perceived stress and anxiety.

Read the full description

Sleep disruption is an important, emerging risk factor for CMD morbidity and mortality \[9\], and is associated with leading cardiometabolic risk factors such as hypertension, insulin resistance, and obesity \[1,2\]. It is likely that poor sleep increases CMD-related risk by promoting circadian disruption \[3\]. A growing body of evidence suggests that ACEs are associated with disturbed sleep. Indeed, strong preliminary evidence from our laboratory indicates that young adults with a history of ACEs self-report poor sleep and present with altered diurnal cortisol concentrations indicative of disrupted circadian variation \[4\]. Accordingly, our hypothesis is that sleep disruption is a hallmark, stress-related symptom of ACEs, and therefore that sleep disruption is a modifiable, mechanistic pathway by which ACEs promote CMD risk. Accordingly, building on our initial data indicating that poor sleep mediates the association between ACE exposure and vascular and metabolic dysfunction, our overall objective in this pilot project is to first (1) test the first line treatment to improve sleep among those suffering from insomnia (CBT-i) for improving sleep in individuals with high ACEs and sleep disruption and (2) explore whether this intervention promotes positive effects on vascular and metabolic health, as well as psychological coping, stress, and anxiety/depression symptoms.

1. St-Onge MP, Grandner MA, Brown D, et al. Sleep Duration and Quality: Impact on Lifestyle Behaviors and Cardiometabolic Health: A Scientific Statement From the American Heart Association. Circulation.

2016;134(18):e367-e86.
2. Cappuccio FP, Miller MA. Sleep and Cardio-Metabolic Disease. Curr Cardiol Rep. 2017;19(11):110.
3. Reutrakul S, Knutson KL. Consequences of Circadian Disruption on Cardiometabolic Health. Sleep Med Clin. 2015;10(4):455-68.
4. Jenkins NDM, Rogers EM, Banks NF, et al. Adverse childhood experiences are linked to disrupted sleep and diurnal cortisol concentrations in young adult women. Circulation. 2022;145:AMP46

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Age 18-29 years, inclusive

-≥4 adverse childhood experiences on the \[CDC-Kaiser 10-item\] ACE questionnaire AND self-reported childhood stress ≥4 on a 0-5 rating scale
* Poor sleep, defined as a PSQI global score \>5 AND PSQI-derived habitual sleep efficiency \<90%
* BMI ≤35 kg/m²
* Either has not been diagnosed with or has been on stable treatment for \>= 6 months for major depressive disorder or major anxiety disorders
* Willing and able to complete the intervention and all study procedures

Exclusion Criteria:

Diagnosed cardiometabolic disease, including cardiovascular disease, hypertension, type 1 or type 2 diabetes, or chronic kidney disease
Diagnosed sleep disorder (e.g., obstructive sleep apnea, insomnia disorder, narcolepsy, restless legs syndrome)
Current shift work involving overnight hours
Children living in the household
Current use of tobacco or nicotine products, including e-cigarettes and vaping
Daily alcohol consumption
Habitual caffeine intake \>5 mg/kg/day

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

CBT-I

Participants will undergo a CBT-i intervention delivered by clinical psychologists using telehealth inside of the UIowa Zoom ecosystem.

Behavioral: Cognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

The CBT-i intervention will be delivered by clinical psychologists (overseen by an experienced PhD-level Clinical Psychologist) who have completed CBT-i training at the University of Iowa. CBT-i is modular, manualized (see example in miscellaneous attachments), and thus highly standardized. CBT-i is the recommended first line treatment for those with insomnia (improving sleep in 75% of these) and has also shown efficacy for improving sleep in those with sub-clinical insomnia and with stress disorders (e.g., PTSD). CBT-i will be delivered in 6, \~1 hour sessions across the course of 6-7 weeks and the topics covered in each session (in order) will be: 1) Sleep Basics, 2) Sleep Schedules, 3) Sleep Hygiene, 4) Stress Management:Relaxation, 5) Stress Management: Stop Worrying About Sleep, 6) Stress Management: Problem Solving.

The intervention sessions will be delivered using telehealth inside of the UIowa Zoom ecosystem using private links.

Prepare your questions