Digital Cognitive Behavioral Therapy for Insomnia

Overseen By RJ Johnson, MA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: National Jewish Health

Must be taking: Hypnotics

Must not be taking: Sedating antidepressants, Antipsychotics

Disqualifiers: Psychotic disorder, Bipolar, Alcohol abuse, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 22

Duration: 22 weeks

430 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if digital cognitive behavioral therapy (delivered through digital platforms) combined with a plan to reduce medication is more effective than reducing medication alone for people with insomnia. Many individuals with insomnia rely on sleep medications, which can pose risks over time. The trial seeks participants who have used sleep medications like benzodiazepines for over six months and wish to reduce their usage. The goal is to assess whether digital therapy can aid in reducing medication use and improving sleep. This could lead to better, more accessible treatment options for those struggling with insomnia. As a Phase 4 trial, the research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial focuses on reducing or eliminating the use of hypnotic medications for insomnia, so you may need to taper off these medications as part of the study. However, the protocol does not specify if you must stop other medications, but it does exclude those using certain medications for other conditions.

What is the safety track record for these treatments?

Research has shown that Digital Cognitive Behavioral Therapy for Insomnia (dCBTI) is generally safe and easy to manage. Studies have found that dCBTI effectively reduces insomnia symptoms without causing significant side effects. For instance, a large study with 4,052 patients found that dCBTI improved sleep more effectively than medication and did not report any major negative effects.

In this trial, dCBTI is used alongside a structured plan to gradually reduce sleep medication, helping to safely decrease reliance on these drugs. Since this trial is in its later stages, sufficient evidence supports the safety of these methods.

Overall, both dCBTI and the gradual reduction of medication aim to improve sleep without the risks associated with long-term medication use, such as falls or memory problems. This makes them promising options for managing insomnia. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about digital cognitive behavioral therapy (dCBTI) for insomnia because it offers a unique, tech-savvy approach to treatment. Unlike traditional methods that often rely on medications, dCBTI uses an online platform to help retrain the brain's sleep patterns through cognitive and behavioral techniques. This method not only aims to address the root causes of insomnia but also provides the convenience of accessing therapy from home. Additionally, when combined with structured medication tapering, it offers an innovative way to potentially reduce reliance on sleep medications, which can have side effects. Overall, this approach could transform how we manage insomnia, making effective treatment more accessible and personalized.

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

Research has shown that digital cognitive behavioral therapy for insomnia (dCBTI), which participants in this trial may receive, can greatly improve sleep. One study found that 60% of people using dCBTI experienced significant improvement in their insomnia, compared to only 16% with other treatments. Another study found that dCBTI was more effective than medication after six months, improving sleep quality and significantly reducing insomnia symptoms. These results suggest that dCBTI could be a strong option for managing insomnia, especially for those looking to reduce sleep medications. Meanwhile, another treatment arm in this trial involves structured medication tapering alone, which will be assessed for its effectiveness in managing insomnia. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with insomnia who've been using sleep meds (benzodiazepine or non-benzodiazepine) regularly for over 6 months and want to cut down. They must meet the DSM-5 criteria for insomnia disorder and be willing to consent to participate.

Inclusion Criteria

I am willing to sign a consent form to participate.

I want to reduce or stop using sleep medications.

I have used sleep medication almost every night for more than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either digital cognitive behavioral therapy combined with structured medication tapering or structured medication tapering alone

22 weeks

Regular visits as per treatment protocol

Follow-up

Participants are monitored for insomnia remission and hypnotic discontinuation rates

27 weeks

Post-treatment assessments at weeks 22 and 49

What Are the Treatments Tested in This Trial?

Interventions

• Digital Cognitive Behavioral Therapy
• Structured Medication Tapering

Trial Overview

The study tests if digital Cognitive Behavioral Therapy combined with a structured plan to gradually reduce sleep medication is more effective than reducing medication alone in primary care patients dependent on hypnotics.

How Is the Trial Designed?

Group I: Structured medication tapering alone Experimental Treatment 1 Intervention

Structured medication tapering delivered alone with general sleep hygiene information.

Group II: Digital cognitive behavioral therapy combined with structured medication tapering Experimental Treatment 2 Interventions

dCBTI delivered in tandem with SMT during intervention phase.

Who Is Running the Clinical Trial?

National Jewish Health

Lead Sponsor

Trials

145

Recruited

318,000+

Published Research Related to This Trial

A smartphone-based, culturally adapted digital cognitive behavioral therapy for insomnia (DCBT-I) significantly reduced insomnia severity compared to sleep education in a randomized trial with 82 participants over 6 weeks.

Participants in the DCBT-I group experienced greater improvements in total sleep time and sleep efficiency at both 3 and 6 months follow-up, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. Zhang, C., Liu, Y., Guo, X., et al.[2023]

Digital cognitive behavioral therapy for chronic insomnia (D-CBT-I) is effective, with 46.4% of 414 participants achieving remission after a 6-week treatment, making it a strong first-line option for chronic insomnia.

Factors such as longer early morning awakening times and higher baseline insomnia severity negatively impacted treatment outcomes, suggesting that patients with milder insomnia and more severe depressive symptoms may benefit more from D-CBT-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing the effectiveness of digital cognitive behavioural therapy for chronic insomnia in clinical practice. Shi, Y., Ren, R., Zhang, Y., et al.[2023]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

In a study involving 1720 adults with insomnia, digital cognitive behavioral therapy for insomnia (dCBT-I) significantly reduced intraindividual variability in sleep metrics, particularly in sleep onset latency, which is crucial for improving sleep quality.

The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting the effectiveness of dCBT-I as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Vestergaard, CL., Vedaa, Ø., Simpson, MR., et al.[2021]

A study involving 75 participants with insomnia disorder showed that an interactive online cognitive behavioral therapy (CBT-i) significantly improved sleep efficiency and sleep latency, indicating its efficacy as a treatment option.

Rigorous screening revealed that 62% of those who accessed the therapy had other sleep disorders, highlighting the importance of proper assessment before starting treatment to ensure effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot evaluation of an online cognitive behavioral therapy for insomnia disorder - targeted screening and interactive Web design lead to improved sleep in a community population. Anderson, KN., Goldsmith, P., Gardiner, A.[2021]

Digital cognitive behavioral therapy for insomnia (dCBT-I) was found to be more effective than medication alone in reducing insomnia symptoms, with significant improvements in Pittsburgh Sleep Quality Index scores over 6 months for dCBT-I and combination therapy.

While dCBT-I showed comparable effectiveness to combination therapy, its benefits were less stable over time, indicating that while it is a strong treatment option, further research is needed to understand its long-term reliability in different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. Lu, M., Zhang, Y., Zhang, J., et al.[2023]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in adults with chronic insomnia, with these benefits sustained up to 48 weeks after treatment.

dCBT also reduces the use of both prescription and non-prescription sleep medications compared to sleep hygiene education, indicating its effectiveness in managing insomnia without relying heavily on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. Luik, AI., Marsden, A., Emsley, R., et al.[2021]

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