Adapted CBT-I for Insomnia

Overseen By Wilfred R Pigeon, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must not be taking: Stimulants, Intravenous drugs

Disqualifiers: Cognitive behavioral therapy, Oncology, Pregnancy, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new version of cognitive behavioral therapy for insomnia (CBT-I), delivered over the phone, targeting individuals who drink alcohol at hazardous levels and struggle with insomnia. The goal is to determine if this treatment is practical to deliver and effective in reducing both alcohol use and insomnia severity. Participants will either receive this therapy or join a control group that receives general education on sleep and alcohol. This trial may suit individuals living in New York State who drink more than the recommended limit and have ongoing insomnia issues. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve treatment options for insomnia and alcohol use.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are undergoing oncology treatment or have a serious medical condition, you may be excluded from participating.

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 safe and manageable. Studies have found that CBT-I can improve sleep problems without causing side effects. Unlike some sleep medications, CBT-I carries a lower risk of relapse, allowing people to maintain good sleep over time. This means unexpected issues are unlikely with CBT-I.

Overall, CBT-I is considered a safe option for those struggling with insomnia, even for individuals who consume alcohol. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it adapts cognitive-behavioral therapy for insomnia (CBT-I) specifically for individuals who also have hazardous alcohol use. Unlike standard CBT-I, which focuses solely on sleep issues, this version also addresses the impact of alcohol on sleep, potentially making it more effective for this unique group. Delivered through four telephone-based sessions over six weeks, it offers a convenient and accessible way to tackle insomnia, especially for those who might struggle with traditional in-person therapy sessions.

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

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive as part of the Insomnia Treatment arm, effectively treats insomnia. Studies have found that CBT-I greatly reduces insomnia severity. It works as well as sleep medications but without side effects, and it often helps people continue improving their sleep over time. CBT-I also benefits those with other health issues, making it potentially helpful for individuals with both insomnia and alcohol use problems. In summary, evidence strongly supports CBT-I as a reliable treatment option for better sleep. ^{1 2 5 6 7}

Who Is on the Research Team?

Wilfred R Pigeon, PhD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for adults in Monroe County, NY or nearby who drink more alcohol than low-risk guidelines suggest and have insomnia. They must speak English and not be getting treatment for alcohol issues, pregnant, planning pregnancy soon, or using IV drugs. People with serious medical conditions or significant sleep disorders other than insomnia are also excluded.

Inclusion Criteria

Current alcohol use (past 30 days) in excess of low-risk drinking guidelines as defined by U.S. Department of Health and Human Services and U.S. Department of Agriculture's 2015-2020 Dietary Guidelines for Americans using four items: 1) any use of alcohol; 2) the number of days that alcohol was used; 3) on days of alcohol use, the usual number of drinks; 4) number of days with 4/5 or more drinks on the same 'occasion' defined as 'at the same time or within a couple hours of each other'. Based on these responses, we will determine if the individual exceeds low-risk drinking guidelines

Comprehension of written and spoken English (because we are developing and testing a new intervention for which translated materials are not available)

Alcohol Use Disorder Identification Test (AUDIT) score of 8-15 to identify alcohol use that is in the hazardous zone

Exclusion Criteria

Providing false information such as false name, contact information, or study responses

Current or recent (past year) intravenous drug use or non-prescribed use of stimulant medications (e.g., cocaine, methamphetamines) (from TLFB and self-report question prompts)

Current pregnancy or intent to become pregnant during the next 6 months or given birth in the past 3 months or currently breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot

A small, open label pilot to develop and refine procedures for administering the intervention

6 weeks

4 telephone-based sessions

Randomized Trial

A small randomized trial comparing the intervention to a sleep and alcohol education control condition

6 weeks

4 telephone-based sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Education Control
• Insomnia Treatment

Trial Overview The study tests a new phone-delivered cognitive behavioral therapy (CBT) specifically designed for people who drink hazardously and have trouble sleeping. Participants will either receive this adapted CBT-I over four sessions or get education about sleep and alcohol as a control comparison.

How Is the Trial Designed?

Group I: Insomnia Treatment Experimental Treatment 1 Intervention

Cognitive-behavioral therapy for insomnia adapted to hazardous alcohol users comprised of four telephone-based sessions delivered over six weeks.

Group II: Education Control Placebo Group 1 Intervention

A combination of alcohol education and sleep hygiene education comprised of four telephone-based sessions delivered over six weeks.

Insomnia Treatment is already approved in United States for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Alcohol Use Disorder (as adjunct therapy)

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

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 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 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) 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]

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 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 study of 188 adults with persistent insomnia, full cognitive behavior therapy (CBT) showed the greatest overall improvements in sleep, with 67.3% of participants responding positively after treatment, compared to 67.4% for behavior therapy (BT) and 42.4% for cognitive therapy (CT).

While BT provided quicker results, its benefits were not as long-lasting, with a significant drop in response rates at the 6-month follow-up, whereas CT showed slower but sustained improvements over time, highlighting the different effectiveness trajectories of these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. Harvey, AG., Bélanger, L., Talbot, L., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep parameters in 51 patients with chronic insomnia, including reductions in sleep latency, number of awakenings, and overall sleep quality, with effects lasting for at least 3 months after treatment.

Post-treatment, patients with insomnia showed no significant differences in sleep quality and mental health symptoms compared to healthy controls, indicating that CBT-I can effectively restore normal sleep patterns and improve overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for chronic insomnia]. Fornal-Pawłowska, M., Szelenberger, W.[2018]

Cognitive behavioural therapy for insomnia (CBT-I) is highly effective, but there is a need to tailor it to individual needs, especially for those with comorbid conditions like depression or chronic pain.

Current research highlights the importance of adapting CBT-I for different contexts and individuals, but there are gaps in methodology and evaluation of these tailored approaches, indicating a need for further studies to optimize treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring cognitive behavioural therapy for insomnia across contexts, conditions, and individuals: What do we know, where do we go? Crowther, ME., Saunders, WJ., Sletten, TL., et al.[2023]

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]

Citations

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

Cognitive-Behavioral Therapy for Insomnia: An Effective ... CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10002474/

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer Finally, one study showed that CBT-I could even be effective in treating insomnia among “real world” patients (i.e., those with comorbid medical and behavioral ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/article-abstract/2839294

Cognitive Behavioral Therapy for Insomnia in People With ... CBT-I was associated with significantly improved outcomes for insomnia severity (g = 0.98; 95% CI, 0.81-1.16) and moderate effect sizes ...

4. 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 ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000594

Effects of cognitive behavioral therapy for insomnia (CBT-I) ... The effects of cognitive behavioral therapy for insomnia (CBT-I) have consistently been shown to improve insomnia symptoms and other health-related outcomes.

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

a focus on components of cognitive behavioral therapy for ... This review highlights the potential of individual components of CBT-I as effective stand-alone interventions for insomnia, as well as digital ...