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

Trial Summary

What is the purpose of this trial?

The goal of this intervention development trial is to develop, refine, and test a telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia adapted to hazardous alcohol users with co-occurring insomnia. The project will begin with a small, open label pilot to refine the intervention and proceed to a small, randomized trial comparing the intervention to a sleep and alcohol education control condition. The two main questions it aims to answer are whether the intervention is feasible to deliver and whether its effects on alcohol use and insomnia severity are large enough to warrant further work.

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.

What data supports the effectiveness of the treatment Adapted CBT-I for Insomnia?

Research shows that cognitive behavioral therapy for insomnia (CBT-I) is highly effective and is the first choice for treating insomnia, even when it occurs alongside other health issues. This suggests that adapting CBT-I for different individuals and contexts, like those with asthma, could also be beneficial. ^{1 2 3 4 5}

Is Adapted CBT-I for Insomnia safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe and effective for treating insomnia without the risks associated with sleeping medications. ^{2 6 7 8 9}

How is CBT-I different from other insomnia treatments?

CBT-I (Cognitive Behavioral Therapy for Insomnia) is unique because it is a non-drug treatment that focuses on changing sleep habits and thoughts about sleep, making it adaptable for individuals with other health conditions. Unlike medications, it can be tailored to fit different personal and cultural contexts, and it is considered the first-line treatment for both simple and complex cases of insomnia. ^{1 2 6 10 11}

Research Team

Wilfred R Pigeon, PhD

Principal Investigator

University of Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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) 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-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]

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 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 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) 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 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) 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tailoring cognitive behavioural therapy for insomnia across contexts, conditions, and individuals: What do we know, where do we go? [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Poland pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for chronic insomnia]. [2018]

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

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

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

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. [2022]

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

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

7. 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]

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

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

9. 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]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]

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

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