An interventional study of Cognitive Behavioral Therapy for Insomnia in Adverse Childhood Experiences, Sleep Disruption and Vascular Dysfunction, sponsored by University of Iowa. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Iowa · Not applicable, Interventional, and Other
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.
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.
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.
University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Flow mediated dilation
Brachial artery flow mediated dilation will be measured as a non-invasive indicator of endothelial function.
Time frame: Prior to and at the end of 6 week CBT-I intervention
Heart Rate Variabiliy
Heart rate signals will be recorded using 3-lead ECG for 10 minutes while the participant rests quietly for measurement of heart rate and heart rate variability
Time frame: Prior to and at the end of 6 week CBT-I intervention
Beat to beat blood pressure variability
Beat-to-beat blood pressure signals will be recorded using finger photoplethysmography for 10 minutes while the participant rests quietly for measurement of blood pressure and blood pressure variability
Time frame: Prior to and at the end of 6 week CBT-I intervention
Homeostatic Model Assessment of Insulin Resistance
A fasting blood sample will be drawn to calculate HOMA-IR as (fasting glucose \[mg/dL\] x fasting insulin \[uIU/mL\] / 405)
Time frame: Prior to and at the end of 6 week CBT-I intervention
Waist Circumference
Participants will have their waist circumference measured using a flexible Gulick tape.
Time frame: Prior to and at the end of 6 week CBT-I intervention
Plan to share: No — Individual participant data will not be shared. This is a small pilot study, and the data include sensitive information on adverse childhood experiences, mental health, and sleep. Given the small sample and the detailed demographic, health, and household information collected, the risk of re-identification cannot be adequately mitigated, even after de-identification. Participants were not consented for sharing of individual-level data with other researchers. Aggregate results will be reported in publications.
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in May 2023, 3 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.