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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) in enhancing sleep and cognitive function among older African American adults. CBT-I targets sleep habits and attitudes, offering a long-term solution for insomnia without medication. Participants will either attend eight weekly CBT-I sessions or receive a single session on sleep hygiene education. This trial suits African American adults aged 60 and over who have experienced insomnia for three months or more and wish to try CBT-I via Zoom. As an unphased trial, it provides participants the chance to contribute to important research on non-medication-based insomnia treatments.

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 prior data suggests that Cognitive Behavioral Therapy for Insomnia is safe for older African American adults?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is a safe and effective treatment for sleep problems. Unlike sleeping pills, CBT-I does not have side effects. Studies have found that CBT-I improves sleep without causing harm. It is often recommended as the first choice for treating insomnia due to its effectiveness and safety. Additionally, individuals using CBT-I often experience continued improvement in sleep over time, with fewer recurrences of insomnia compared to those using sleep medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBT-I) because it offers a unique approach compared to traditional treatments like medications or basic sleep hygiene education. Unlike sleeping pills that mainly address symptoms, CBT-I targets the root causes of insomnia by changing the negative thoughts and behaviors that keep people awake. This method not only aims for long-term improvement of sleep quality but also avoids potential side effects associated with medication use. By focusing on reshaping sleep habits and patterns, CBT-I provides a more sustainable and personalized solution for those struggling with insomnia.

What evidence suggests that this trial's treatments could be effective for insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), one of the treatments in this trial, can improve sleep problems. One study found that CBT-I increased total sleep time by about 8 minutes and improved sleep quality by 10%. This therapy changes thoughts and behaviors about sleep, leading to better long-term sleep habits. Another study found that group CBT-I improved sleep quality and helped participants fall asleep faster. These findings suggest that CBT-I can be as effective as sleep medications but without the side effects, making it a promising option for managing insomnia. Participants in this trial may also receive sleep hygiene education, which serves as an active comparator. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark Gluck, PhD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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) 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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796223/

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 ...

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

main outcomes of a randomized dismantling trial A greater reduction in dysfunctional beliefs about sleep (DBAS) from baseline is associated with greater insomnia symptom improvement after ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S138994572500156X

Effectiveness of group-delivered cognitive behavioural ... Results from a meta-analysis showed that group-delivered CBT-I led to improved sleep quality and better sleep, especially regarding sleep onset latency, sleep ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803668

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 ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1413694/full

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.

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

a focus on components of cognitive behavioral therapy for ... A 2024 component network meta-analysis found SCT to be potentially beneficial for insomnia treatment (iOR, 1.43; 95% CI, 1.00–2.05) and is ...