Online Cognitive Behavioural Therapy for Insomnia

(e-COSMOS Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled clinical trial is to assess a novel cognitive-behavioral program for sleep and mental health using a multidomain web platform (eCBTi+) in participants with insomnia and subjective cognitive complaint. The main questions it aims to answer are: * Whether the eCBTi+ intervention improves sleep (subjective: Insomnia severity index \[ISI\], objective: EEG-based sleep efficiency) sleep and mental health (Geriatric Anxiety Index \[GAI\] and Geriatric Depression Scale \[GDS\]) compared to the control intervention * Whether the eCBTi+ intervention improves cognitive abilities (subjective: Cognitive Failure Questionnaire \[CFQ\], objective: CANTAB executive functions composite score) compared to the control intervention

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 data supports the effectiveness of the treatment Online Cognitive Behavioural Therapy for Insomnia?

Research shows that online cognitive behavioral therapy for insomnia (CBT-I) can improve sleep quality and reduce insomnia severity. Studies have found that it helps people fall asleep faster and stay asleep longer, making it a good alternative when in-person therapy isn't available. ^{1 2 3 4 5}

Is online cognitive behavioral therapy for insomnia safe for humans?

Online cognitive behavioral therapy for insomnia (CBT-I) is generally considered safe for humans, as it is a non-invasive treatment that uses psychological and behavioral techniques to improve sleep. It has been shown to improve sleep quality and reduce insomnia severity without significant safety concerns. ^{1 2 3 5 6}

How is the online cognitive behavioral therapy for insomnia treatment different from other treatments for insomnia?

This treatment is unique because it is delivered online, making it more accessible and cost-effective for a large number of patients, especially older adults with insomnia and cognitive complaints. It combines behavioral strategies like sleep restriction and relaxation with cognitive and educational components, and it addresses the shortage of trained clinicians by providing therapy through a digital platform. ^{1 2 4 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

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

2. New Zealand 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. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

On the Efficacy of a CBT-I-Based Online Program for Sleep Problems: A Randomized Controlled Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy for insomnia and depression: qualitative reflections from older adults who participated in a randomised controlled trial. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. [2023]

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

Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia. [2020]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study. [2023]