Online Cognitive Behavioural Therapy for Insomnia

(e-COSMOS Trial)

Recruiting at 2 trial locations

Overseen By Rebecca Robillard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Must not be taking: Hypnotics, Psychotropics

Disqualifiers: Neurocognitive disorder, Schizophrenia, Bipolar, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

Duration: 10 weeks

275 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program designed to assist older adults with sleep issues and mental health concerns like anxiety and depression. The program, called Online Cognitive Behavioural Therapy for Sleep and Mental Health, provides weekly sessions that participants can complete independently, aiming to improve sleep quality, mental health, and cognitive abilities. Ideal participants are those aged 60 or older who have trouble sleeping and experience some cognitive challenges, and they must be comfortable using the internet and a smartphone or tablet. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance mental health care for older adults.

Will I have to stop taking my current medications?

The trial requires that if you are on hypnotic or psychotropic medication (including cannabis), you must be on a stable dosage for at least 2 months before joining. If you are taking these medications, you won't need to stop, but you must not change the dosage.

What prior data suggests that this online cognitive behavioral therapy is safe for older adults with insomnia and subjective cognitive complaints?

Research shows that online cognitive behavioral therapy for insomnia is generally safe. Studies have found that digital CBT-I can significantly improve sleep quality and reduce insomnia symptoms. It often serves as the first choice for treating long-term insomnia in adults, indicating it is usually well-received.

Serious side effects from online therapy like this are rare. Most people experience only mild and short-term issues, such as slight increases in anxiety or frustration. These typically resolve after a few sessions as users become more comfortable with the program.

Overall, the safety record for digital CBT-I is positive. Participants can expect a safe experience with the potential for better sleep and improved mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of online cognitive behavioral therapy (CBT) to improve sleep and mental health in older adults. Unlike traditional in-person CBT, this treatment is delivered online through 10 self-directed modules, providing flexibility and accessibility for participants. This method could be particularly beneficial for older adults who may face mobility issues or live in remote areas. Additionally, the trial includes a comparison with an online intervention focusing on nutrition and communication, which could help in understanding the broader benefits of online behavioral interventions for mental health and cognitive issues. Ultimately, this trial could pave the way for more accessible mental health care solutions tailored to the needs of older adults.

What evidence suggests that this online cognitive behavioral therapy is effective for insomnia?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) effectively improves sleep issues. In this trial, one group of participants will receive online cognitive behavioral therapy for insomnia, anxiety, and depression. One study found that digital CBT-I not only reduced insomnia symptoms but also helped with depression and anxiety. Another study demonstrated that CBT-I effectively aids those with both insomnia and mental health conditions like depression or PTSD. Doctors often recommend this therapy as the first choice for treating insomnia. It uses techniques to help individuals fall asleep faster and stay asleep longer. Overall, CBT-I has a strong history of improving sleep and reducing anxiety or depression. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older who have trouble sleeping (insomnia) and feel their memory isn't as good as it used to be. They should be able to read French or English, use a smartphone or tablet, and have internet at home. If they're taking sleep or mood medications, the dose must have been the same for at least two months.

Inclusion Criteria

I have been on a stable dose of my mental health or sleep medication, including cannabis, for at least 2 months.

Sleep Condition Indicator (SCI) score ≤ 16 and meeting DSM-V criteria based on symptoms assessed by SCI

Subjective cognitive complaints (self-report version of Everyday Cognition scale (ECog), score ≥ 3 on any item)

Exclusion Criteria

Apnea-hypopnea index >10 on a level 3 home sleep apnea test or residual AHI >10 for individuals on CPAP

Unable or unwilling to come to one of the participating MRI centers (Montreal, Ottawa)

I haven't taken any psychiatric or sleep medications in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phone interview and video conferences

Treatment

Participants undergo 10 weeks of online cognitive-behavioral therapy or control intervention

10 weeks

10 online modules, weekly

Monitoring

Participants complete sleep diaries, wear actigraphy devices, and undergo cognitive testing

10-12 weeks

At-home polysomnography, online questionnaires, and cognitive testing sessions

Follow-up

Participants are monitored for changes in sleep and cognitive performance

24 weeks

Assessments at baseline, 10-12 weeks, and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints

Trial Overview

The study tests an online program that combines cognitive-behavioral therapy with education on nutrition and communication aimed at improving sleep, anxiety, depression, and cognitive abilities in older adults with insomnia and self-perceived memory issues.

How Is the Trial Designed?

Group I: online cognitive behavioral therapy for insomnia, anxiety and depression Experimental Treatment 1 Intervention

10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week

Group II: online intervention on nutrition and communication in older age Active Control 1 Intervention

10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week

Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia (CBT-I) for:

• Insomnia
• Depression
• Anxiety

Approved in European Union as Cognitive Behavioral Therapy for Insomnia (CBT-I) for:

• Insomnia
• Depression
• Anxiety

Who Is Running the Clinical Trial?

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Lead Sponsor

Trials

26

Recruited

9,500+

Published Research Related to This Trial

Cognitive-behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia in older adults, addressing both primary and comorbid insomnia, as well as those dependent on sleep medications.

CBT-I combines behavioral and cognitive strategies to improve sleep, leading to better overall physical and mental health and enhancing the quality of life for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy for insomnia]. Yamadera, W.[2018]

Cognitive behavioural therapy for insomnia (CBT-I) delivered through a computerized format (CCBT-I) could improve access to treatment, as it addresses the shortage of trained providers, according to interviews with 23 health professionals and 28 patients.

To enhance the effectiveness and adherence to CCBT-I, the program must focus on building trust through accreditation and evidence of effectiveness, while also incorporating features like mobile access, self-assessment tools, and moderated peer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study. Middlemass, J., Davy, Z., Cavanagh, K., et al.[2023]

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]

A randomized clinical trial involving 303 adults with chronic insomnia demonstrated that the internet-delivered CBT-I program (SHUTi) significantly improved insomnia severity and sleep outcomes over 9 weeks, with effects maintained for up to 1 year.

At the 1-year follow-up, 56.6% of participants achieved remission from insomnia, highlighting the long-term efficacy of this automated intervention compared to standard online patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. Ritterband, LM., Thorndike, FP., Ingersoll, KS., et al.[2022]

A randomized controlled trial with 53 participants demonstrated that a 6-week online cognitive behavioral therapy for insomnia (CBT-I) program led to significant improvements in sleep quality, including reduced wake time after sleep onset and increased sleep efficiency.

The online CBT-I program not only improved subjective sleep quality but also showed objective benefits measured by polysomnography, making it a promising alternative for those unable to access traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the Efficacy of a CBT-I-Based Online Program for Sleep Problems: A Randomized Controlled Trial. Eigl, ES., Hauser, T., Topalidis, PI., et al.[2023]

Older adults (average age 75) reported positive experiences with cognitive behaviour therapy for insomnia and depression, noting that the strategies helped reduce their symptoms and appreciated the support from therapists and group interactions.

Participants suggested improvements for future programs, including extending the therapy duration from 8 to 12 sessions, incorporating multi-dimensional learning methods, and providing various delivery options like group or online sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy for insomnia and depression: qualitative reflections from older adults who participated in a randomised controlled trial. Sadler, P., McLaren, S., Klein, B., et al.[2021]

A study involving 95 adults with chronic insomnia found that fully automated Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) led to significant improvements in sleep quality and daytime functioning, which were maintained 18 months after the intervention.

Participants showed large effect size improvements in insomnia severity, daytime fatigue, and beliefs about sleep, indicating that unguided Internet CBT-I can provide lasting benefits for individuals struggling with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia. Vedaa, Ø., Hagatun, S., Kallestad, H., et al.[2020]

The Nitra application, an internet-based cognitive behavioral therapy for insomnia (CBT-i), significantly improved sleep efficiency and various sleep parameters in 40 adults with chronic subthreshold to moderate insomnia over a 4-week intervention period.

Participants who adhered closely to the recommended sleep schedule showed a higher likelihood of achieving normal sleep efficiency, highlighting the importance of consistent sleep habits in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. Theppornpitak, W., Hemrungrojn, S., Thienwiwatnukul, K., et al.[2023]

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