Cognitive Behavioral Therapy for Insomnia

Overseen By Bernadette A Fausto, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Benzodiazepines, Z Drugs, Antidepressants, others

Disqualifiers: Other sleep disorders, High fall risk, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking certain medications like benzodiazepines, Z drugs, certain antidepressants, antihistamines, or barbiturates, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Cognitive-behavioral therapy for insomnia?

Research shows that cognitive-behavioral therapy for insomnia (CBT-I) is effective in reducing insomnia symptoms and improving sleep quality, even in people with other psychiatric conditions. Studies have demonstrated its benefits for both daytime and shift workers, with positive outcomes lasting up to 24 months after treatment. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe and is recommended as a first-line treatment for insomnia without the risks associated with sleeping medications. However, there is limited information on adverse events, and more consistent monitoring and reporting are needed to fully understand any potential negative effects. ^{6 7 8 9 10}

How is cognitive-behavioral therapy for insomnia different from other treatments for insomnia?

Cognitive-behavioral therapy for insomnia (CBT-I) is unique because it focuses on changing sleep habits and beliefs about sleep through structured sessions, rather than using medication. It is considered the first-line treatment for chronic insomnia and is known for producing long-lasting improvements in sleep quality. ^{7 11 12 13 14}

What is the purpose of this trial?

Sleep problems, like insomnia, are common in older African Americans. About 25% of older adults in the US have at least 2 symptoms of insomnia, such as having trouble falling asleep, staying asleep, or getting good sleep for a month or more. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a recommended non-pharmacological treatment for insomnia. Unlike medicines that might only help for a short time or have many side effects, CBT-I deals with the root causes of insomnia. It helps people change how they think and act about sleep, leading to better habits and attitudes. This can make sleep better for a long time, even after the treatment is over. While CBT-I is commonly used among adults with insomnia, its benefits among older adults and specifically older African American adults are not well understood. Thus, the current pilot study will investigate the feasibility of CBT-I in older African American adults and establish preliminary evidence for the potential benefit of CBT-I on sleep as well as cognition in this population. For this study, participants will be asked to complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, which collects specific sleep measures such as brain waves and sleep stage timing, and computer-based neuropsychological tests before and after intervention. Study interventions will consist of 8 weekly sleep training sessions via Zoom or a single session of education on strategies to improve sleep quality. Sleep training sessions will include education about strategies to improve sleep quality, changing thought process that contribute to insomnia, training the brain on the optimal sleep environment, and reducing sleep initially to establish a consistent sleep schedule before increasing sleep time. Three months after the post-intervention visit, participants will be asked to come back in for a follow-up evaluation which consists of complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, and computer-based neuropsychological tests.

Research Team

Mark Gluck, PhD

Principal Investigator

Rutgers University

Eligibility Criteria

This trial is for older African American adults experiencing insomnia symptoms like trouble falling or staying asleep. Participants should be willing to undergo sleep and cognitive assessments, attend weekly Zoom sessions, and follow the study's procedures.

Inclusion Criteria

Self-identify as African American or Black

I am willing to attend 8 CBT-I sessions on Zoom.

I am 60 years old or older.

Exclusion Criteria

I am currently taking medication that affects my sleep.

I have a sleep disorder that is not insomnia.

My frequent awakenings are due to a condition like chronic pain, not just insomnia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 weekly sleep training sessions via Zoom or a single session of education on strategies to improve sleep quality

8 weeks

8 visits (virtual) or 1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive tests and sleep monitoring

12 weeks

1 visit (in-person)

Treatment Details

Interventions

• Cognitive-behavioral therapy for insomnia
• Sleep hygiene education

Trial Overview The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I) against basic sleep hygiene education. CBT-I involves changing thoughts and behaviors around sleep through weekly training sessions, while the control group receives a single educational session.

Participant Groups

Group I: CBT-I Experimental Treatment 1 Intervention

Group II: Sleep hygiene education Active Control 1 Intervention

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

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) 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) is recognized as the best treatment for chronic insomnia, yet it is significantly underutilized despite the high number of people affected by insomnia disorder.

The article highlights the need for further research on how to effectively deliver CBT-I, identify suitable candidates for the therapy, and measure the quality of care provided, which are essential for improving its real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. Buenaver, LF., Townsend, D., Ong, JC.[2019]

A study involving 188 patients with insomnia found that cognitive behavior therapy (CBT) led to greater improvements in insomnia severity and overall health compared to cognitive therapy (CT) and behavior therapy (BT) after 12 months.

All three therapies (CT, BT, and CBT) were effective in reducing insomnia symptoms and improving daytime functioning, but CBT showed specific advantages, especially for patients with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month follow-up: Comparative efficacy of cognitive therapy, behavior therapy, and cognitive behavior therapy for patients with insomnia. Sarfan, LD., Morin, CM., Harvey, AG.[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]

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]

In a review of 99 randomized controlled trials on cognitive behavioral therapy for insomnia (CBTI), only 32.3% addressed adverse events, highlighting a significant gap in monitoring during psychological treatment compared to pharmacotherapy.

Only 7.1% of the studies met all criteria for adequate reporting of adverse events, indicating a need for improved standards in documenting potential negative effects of CBTI to ensure patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. Condon, HE., Maurer, LF., Kyle, SD.[2021]

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 (CBT) for insomnia is a structured approach that effectively changes poor sleep habits and beliefs, making it the first-line treatment for chronic insomnia in adults according to clinical guidelines.

CBT leads to more significant and lasting improvements in sleep quality and insomnia symptoms compared to medication alone, despite requiring more time from both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approach to treating insomnia M Morin, C., Beaulieu-Bonneau, S.[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]

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 (CBT) is a safe and effective treatment for insomnia, showing positive results in 70% to 80% of patients, and can be used alone or alongside medication.

CBT addresses insomnia through behavioral, cognitive, and educational strategies, significantly reducing sleep-onset latency and wake-after-sleep onset, while also helping patients regain control over their sleep and reduce emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approaches to the treatment of insomnia. Morin, CM.[2022]

References

1. 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]

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

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

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

Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Are changes in worry associated with treatment response in cognitive behavioral therapy for insomnia? [2018]

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

Twelve-month follow-up: Comparative efficacy of cognitive therapy, behavior therapy, and cognitive behavior therapy for patients with insomnia. [2023]

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

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

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

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. [2021]

9. 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]

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

An open trial of cognitive therapy for chronic insomnia. [2018]

11. France pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approach to treating insomnia [2019]

12. England pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

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

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

Cognitive-behavioral approaches to the treatment of insomnia. [2022]