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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep problems linked to difficult childhood experiences affect heart and blood vessel health. Researchers aim to determine if Cognitive Behavioral Therapy for Insomnia (CBT-i) can improve sleep and, consequently, help with related cardiovascular issues. The trial seeks young adults who have faced challenging early life experiences and frequently experience sleep difficulties. Participants will either receive the CBT-i treatment or be placed on a waitlist for comparison. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future treatments for sleep-related health issues.

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 prior data suggests that cognitive behavioral therapy for insomnia is safe?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-i) is a safe and effective method to improve sleep. Studies have found that CBT-i helps individuals fall asleep faster and enhances sleep quality without the risks associated with sleeping pills. Many participants report significant improvements in sleep quality, and no major safety issues have emerged. This makes CBT-i a well-tolerated option for addressing sleep problems, even for those with previous negative experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cognitive Behavioral Therapy for Insomnia (CBT-i) is unique because it specifically targets the thoughts and behaviors that disrupt sleep, which can be particularly beneficial for those with sleep issues stemming from adverse childhood experiences. Unlike medications like sleep aids, which often just mask symptoms, CBT-i addresses the root causes of insomnia without the risk of dependency or side effects. Researchers are excited about this therapy because it empowers patients with techniques to improve their sleep patterns in a sustainable way, potentially offering long-term relief from insomnia.

What evidence suggests that Cognitive Behavioral Therapy for Insomnia might be an effective treatment for sleep issues related to adverse childhood experiences?

This trial will compare Cognitive Behavioral Therapy for Insomnia (CBT-i) with a waitlist control group. Studies have shown that CBT-i effectively treats sleep problems. It improves sleep quality, reduces the time it takes to fall asleep, and enhances the ability to stay asleep throughout the night. Research indicates that people using CBT-i experience a significant reduction in insomnia symptoms, with benefits continuing even after therapy ends. A review of multiple studies found that CBT-i helps individuals fall asleep faster and stay asleep longer. This therapy has a strong history of aiding those with long-term sleep issues. ^{1 2 4 6 7}

Who Is on the Research Team?

Nathaniel Jenkins, PhD

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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 (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]

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]

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]

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]

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 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]

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