Sleep Intervention + CBT for Insomnia

Overseen By Jeff Burns, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Benzodiazepines, Melatonin, others

Disqualifiers: Sleep apnea, Severe depression, others

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

Compensation: Varies

Number of Visits: 13

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new six-week sleep program to determine if it can help older adults with insomnia enhance their thinking skills and slow certain brain changes associated with aging. Participants will either engage in a cognitive behavioral therapy program for insomnia (CBT-I, a type of talk therapy) or a sleep and lifestyle education course. Both programs provide practical advice on improving sleep habits. Those who have experienced trouble sleeping at least three nights a week for the past six months might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving sleep health in older adults.

Will I have to stop taking my current medications?

If you are currently taking medications like benzodiazepines, non-benzodiazepines, melatonin supplements, or agonists for insomnia, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and well-tolerated. Studies have found that it can improve sleep without the side effects often linked to sleep medications, offering long-lasting benefits with a lower chance of sleep problems returning. However, some individuals might feel tired or less motivated when starting CBT-I.

Specific safety data for the Sleep and Lifestyle Education program is not available. However, since it involves learning and making lifestyle changes, it is considered low-risk. This program focuses on teaching better sleep habits and healthier lifestyle choices, which are generally safe.

Overall, both treatments in this study appear safe and carry a low risk of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for insomnia because they offer a fresh approach to managing sleep issues. The Six-Week CBT-I Program focuses on changing negative sleep beliefs and behaviors through structured cognitive therapy and controlled sleep adjustments, which is different from standard sleep aids or medications. Meanwhile, the Six-Week Sleep and Lifestyle Education Program emphasizes holistic education about sleep, diet, and exercise impacts, helping participants make informed lifestyle changes. These methods aim to provide longer-lasting sleep improvements without relying on medication.

What evidence suggests that this trial's treatments could be effective for improving cognitive function in older adults with insomnia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, helps improve sleep patterns. Studies indicate that CBT-I can increase total sleep time and improve sleep efficiency by 10%. It matches the effectiveness of sleep medications and offers long-term benefits without drugs. Meanwhile, Sleep and Lifestyle Education, another treatment option in this trial, enhances sleep quality and mental sharpness by teaching good sleep habits. Both treatments offer promising options for managing insomnia symptoms and improving sleep health. ^{1 6 7 8 9}

Who Is on the Research Team?

Catherine Siengsukon, PT, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

Adults aged 60-85 with insomnia symptoms, who have trouble sleeping at least three nights a week for six months and score high enough on mental state exams to show no severe cognitive impairment or dementia. Excluded are those with untreated sleep disorders, severe depression, substance abuse history, certain mental illnesses or learning disabilities, current shift workers, or those already in CBT-I treatment.

Inclusion Criteria

I have had trouble sleeping at least three nights a week for the past six months.

You have a score of 25 or higher on the Mini-Mental State Examination (MMSE).

You have a score of 10 or more on the Insomnia Severity Index.

Exclusion Criteria

You have had trouble learning or paying attention in the past.

I am currently taking medication or supplements for sleep problems.

I have an untreated sleep disorder like sleep apnea or restless leg syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a six-week sleep intervention program, including CBT-I or Sleep and Lifestyle Education

6 weeks

6 sessions (in-person)

Follow-up

Participants are monitored for changes in cognitive function and Aβ deposition

1 year

Reassessments at 6 weeks and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia (CBT-I)
• Sleep and Lifestyle Education

Trial Overview The trial is testing whether a six-week program of Sleep and Lifestyle Education combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve cognitive function and reduce brain amyloid deposits in older adults with insomnia. Some participants will also undergo PET imaging to track changes in amyloid levels over one year.

How Is the Trial Designed?

Group I: Six-Week CBT-I Program Experimental Treatment 1 Intervention

CBT-I, six sessions, forty-five to sixty minutes in duration. Session 1: set up sleep restriction and stimulus control, discuss strategies for how to stay awake to a prescribed hour and what to do with wake after onset sleep time, provide sleep hygiene education. Session 2: determine if upward titration of total sleep time is warranted, review sleep hygiene. Session 3: continue upward titration of total sleep time, cognitive therapy for negative sleep beliefs if indicated. Session 4: continue upward titration of total sleep time, follow-up regarding negative sleep beliefs. Session 5: continue upward titration of total sleep time, discuss relapse prevention. Session 6: assess global treatment gains, discuss questions regarding relapse prevention.

Group II: Six-Week Sleep and Lifestyle Education Program Active Control 1 Intervention

Sleep and Lifestyle Education, six sessions, forty-five to sixty minutes in duration. Session 1: Sleep education, Instruction/demonstration on stretching exercises. Session 2: Education on environmental factors \& sleeping positions that impact sleep. Session 3: Education on lifestyle factors that impact sleep. Session 4: Education on diet and sleep. Session 5: Education on exercises and sleep. Session 6: Discus maintaining achievements \& preventing relapses.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective multi-component treatment for chronic insomnia, which affects 6-10% of the population and can lead to various health issues; it is recommended as the first-line intervention for insomnia.

Despite its proven efficacy and comprehensive evidence base, CBT-I is not widely disseminated, highlighting the need for increased awareness and training among clinicians and researchers to improve treatment access for those suffering from insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer. Walker, J., Muench, A., Perlis, ML., et al.[2023]

A web-delivered cognitive behavior therapy for insomnia (CBTI) program significantly reduced anxiety and insomnia symptoms in a study of 22 adults, demonstrating its efficacy as a treatment option.

Participants in the CBTI group experienced greater improvements in sleep onset latency and overall sleep quality compared to those receiving general sleep hygiene information, suggesting that online CBTI can effectively address insomnia and its comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. Pillai, V., Anderson, JR., Cheng, P., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for chronic primary insomnia, which affects about 10% of adults and is associated with various health risks.

There is ongoing research into extending CBT-I to patients with insomnia related to medical and psychiatric conditions, but there is currently no consensus on the criteria for determining suitable candidates for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who is a candidate for cognitive-behavioral therapy for insomnia? Smith, MT., Perlis, ML.[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) significantly improved sleep in patients with chronic insomnia, with 46% achieving normal sleep ratings after 5 sessions, compared to those receiving standard treatment.

Despite the sleep improvements, CBT-I did not lead to changes in depression, anxiety, or quality of life, and none of the patients chose to stop their hypnotic medications, indicating that while CBT-I can enhance sleep, it may not address broader mental health issues in patients with severe psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a CBT Intervention for Persistent Insomnia and Hypnotic Dependency in an Outpatient Psychiatry Clinic. Taylor, HL., Rybarczyk, BD., Nay, W., et al.[2022]

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 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) 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]

Citations

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Cognitive-Behavioral Therapy for Insomnia: An Effective ... Total sleep time improved by 8 minutes, and sleep efficiency improved by 10%. CBT-i produces results that are equivalent to sleep medication, with no side ...

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Internet-delivered Cognitive Behavioral Therapy for Insomnia confirmed that eCBT-I significantly improves insomnia severity, sleep efficiency, sleep quality, latency, and total sleep time, achieving ...

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Digital Cognitive Behavioral Therapy vs Medication ... In this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits ...

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The efficacy of cognitive behavioral therapy for insomnia in ... CBT-I was effective in improving insomnia in adolescents and some sleep-related outcomes, including sleep onset latency, total sleep time, and sleep efficiency.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11756

main outcomes of a randomized dismantling trial All groups exhibited insomnia symptom reduction at posttreatment (CT: d = −2.53, P < .001; BT: d = −2.39, P < .001; CBT: d = −2.90, P < .001) ...

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Negative effects of cognitive behavioral therapy for insomnia Evidence exists that cognitive behavioral therapy for insomnia (CBT-I) can lead to negative effects (e.g., exhaustion, reduced motivation). Psychometrically ...

7. kosinmedj.org kosinmedj.org/journal/view.php?number=1311

a focus on components of cognitive behavioral therapy for ... Sufficient clinical evidence supports the efficacy of digital CBT-I in treating insomnia. Internationally, various platforms for digital CBT-I ...

8. mayoclinic.org mayoclinic.org/diseases-conditions/insomnia/in-depth/insomnia-treatment/art-20046677

Cognitive behavioral therapy instead of sleeping pills Effective treatment can help you get the sleep you need. Explore safe and effective insomnia treatments that don't include pills.

9. nature.com nature.com/articles/s41746-025-01847-0

A randomized controlled trial of a digital cognitive ... Meta-analyses support CBT-I as efficacious and safe, with long-lasting effects in older adults. As a behavioral rather than pharmacological ...