Cognitive Behavioral Therapy for Sleep Issues from Adverse Childhood Experiences

Overseen By Nathaniel D Jenkins, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nathaniel Jenkins

Must not be taking: Anti-hypertensives, Opiates, Benzodiazepines, others

Disqualifiers: Sleep disorders, Psychiatric disorders, Cardiometabolic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

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. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe and effective for treating insomnia without the risks associated with sleeping medications. ^{1 4 6 7 8}

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. ^{1 4 9 10 11}

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

PSQI Global Score >5

SBP <129 and DBP <90 mmHg

Willing to complete in-home sleep studies

Exclusion Criteria

Currently smoking or using nicotine

Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)

Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cohort Study

Participants undergo sleep monitoring and endothelial function assessment to study the impact of sleep quality on vascular health.

7 nights of wrist actigraphy and 2 nights of polysomnography

Home-based monitoring

Intervention

Participants are randomized to a 6-week behavioral sleep intervention or wait-list control to assess the impact on vascular dysfunction.

6 weeks

Home-based monitoring and assessments

Follow-up

Participants are monitored for changes in vascular function and sleep quality post-intervention.

1 week

Post-intervention assessments

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Insomnia (CBT-i)

Trial Overview 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.

Participant Groups

Group I: Cognitive Behavioral Therapy for Insomnia (CBT-i) Experimental Treatment 1 Intervention

Group II: Waitlist Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Nathaniel Jenkins

Lead Sponsor

Trials

5

Recruited

300+

Findings from Research

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.

While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep quality, sleep onset, and sleep efficiency in 76 patients with primary insomnia over a 6-week group course in a clinical setting.

CBT-I also led to reductions in medication use and improvements in patients' overall health and cognitive functioning, highlighting its effectiveness beyond just sleep improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. Van Houdenhove, L., Buyse, B., Gabriels, L., et al.[2018]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms over a 24-month follow-up among 59 media workers, with 62% of participants showing moderate improvement.

The study found that working hour arrangements did not impact the effectiveness of CBT-I, indicating that this treatment can benefit both daytime and shift workers with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. Järnefelt, H., Sallinen, M., Luukkonen, R., et al.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBTI) is recognized as the first-line treatment for chronic insomnia, supported by strong empirical evidence of its effectiveness, particularly in cases of primary insomnia.

Recent developments in CBTI show promising results for treating insomnia alongside other health conditions, its use as a maintenance therapy, and the potential for delivering CBTI through technology and in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. Siebern, AT., Manber, R.[2022]

Cognitive Behavioral Therapy for insomnia (CBT-i) is an effective first-line treatment for chronic insomnia, showing significant improvements in sleep onset latency (SOL) by about 19 minutes and wake after sleep onset (WASO) by about 26 minutes based on a review of 20 studies involving 1162 participants.

The benefits of CBT-i, which includes techniques like cognitive therapy and sleep hygiene, appear to be sustained over time, and importantly, no adverse effects were reported, making it a safe alternative to pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Trauer, JM., Qian, MY., Doyle, JS., et al.[2022]

Among 59 adults with primary insomnia, 46% reported moderate to severe adverse childhood experiences (ACE), which were linked to significantly worse sleep quality, including more awakenings and movement arousals during the night.

The study suggests that individuals with a history of severe childhood maltreatment may form a distinct subgroup of insomniacs, exhibiting sleep disturbances similar to those seen in trauma victims and PTSD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse childhood experiences associated with sleep in primary insomnia. Bader, K., Schäfer, V., Schenkel, M., et al.[2007]

A review of 12 studies involving 1625 participants found that cognitive behavioral therapy for insomnia (CBT-I) programs implemented in primary care and community settings produced small to moderate improvements in various sleep measures, such as insomnia severity and sleep efficiency.

Despite the potential of non-specialist settings to deliver CBT-I effectively, the variability in program components across studies limited the ability to fully assess the overall impact of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of cognitive behavioral therapy for insomnia implemented in primary care and community settings. Cheung, JMY., Jarrin, DC., Ballot, O., et al.[2019]

A single 4-hour group workshop on cognitive behavioral treatment for insomnia (CBT-I) significantly improved insomnia symptoms in 45 participants, with Insomnia Severity Index scores dropping from an average of 20.09 to 11.89 after one month.

Participants also reported a reduction in sleep aid use, with 80% indicating better sleep quality and 20% achieving remission of insomnia, highlighting the effectiveness of this accessible treatment format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. Okun, ML., Glidewell, RN.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]

6. England pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse childhood experiences associated with sleep in primary insomnia. [2007]

10. England pubmed.ncbi.nlm.nih.gov

A systematic review of cognitive behavioral therapy for insomnia implemented in primary care and community settings. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]