Online Sleep Course for Insomnia

Overseen By Heather Hadjistavropoulos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Severe psychiatric disorder, severe substance use, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 7 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online course designed to help people with insomnia. The study examines the effectiveness of this internet-based therapy for individuals in Australia and assesses the program's ease of completion. It targets adults who struggle with falling asleep, staying asleep, or waking up too early, and who experience daytime fatigue or stress as a result. Participants must reside in Saskatchewan, have internet access, and feel comfortable using a computer or device privately. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance sleep therapy options for many.

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 have a severe medical or psychiatric disorder that requires immediate treatment, you may not be eligible to participate.

What prior data suggests that this online sleep course is safe for individuals with insomnia?

Research has shown that the Sleep Course, an online therapy for insomnia, is generally well-received and safe. In a previous study, 79% of participants expressed satisfaction with the program. Additionally, 70% of participants completed the lessons, indicating that the program is manageable for most people.

The Sleep Course has significantly reduced insomnia symptoms, suggesting it is both safe and effective. No reports of serious side effects have emerged, reassuring those considering joining a trial. This online therapy helps people improve their sleep habits in a structured way, making it a promising option for those with sleep problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the online sleep course for insomnia because it offers a new way to tackle sleep troubles using therapist-guided, Internet-delivered cognitive behavioral therapy (ICBTi). Unlike traditional methods like medication or in-person therapy sessions, this online approach provides flexibility and accessibility, allowing people to engage in therapy from the comfort of their home. Additionally, ICBTi addresses insomnia by changing thought patterns and behaviors that disrupt sleep, which could offer long-lasting benefits without the side effects often associated with sleep medications. This unique delivery method could make effective insomnia treatment more accessible to a broader audience.

What evidence suggests that the Sleep Course is effective for insomnia?

Research has shown that online cognitive behavioral therapy for insomnia (ICBTi), such as the Sleep Course tested in this trial, effectively treats insomnia. Studies indicate that ICBTi reduces insomnia symptoms, improves sleep quality, and enhances overall sleep. For instance, one study noted a 4.3-point drop in insomnia severity. Another study found an average decrease of 7.04 points, with 75.4% of participants completing the treatment. These results suggest that the Sleep Course could be a helpful option for those struggling with sleep issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Heather D Hadjistavropoulos, PhD

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

This trial is for adults experiencing sleep difficulties, such as trouble falling or staying asleep, waking up early, and daytime distress. It's aimed at those who may also be dealing with depression or anxiety. Participants should be seeking help through an online therapy clinic.

Inclusion Criteria

Has comfort using and access to a device or computer with Internet in a private location

Read and understand English

Living in Saskatchewan for the treatment period

Exclusion Criteria

Taking part in another treatment at our clinic.

I do not have a severe illness or mental health condition needing urgent treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Treatment

Participants receive Internet-delivered cognitive behavioral therapy for insomnia (ICBTi) over 7 weeks

7 weeks

Weekly online lessons with therapist support via secure messaging and/or phone calls

Follow-up

Participants are monitored for changes in insomnia symptoms, attitudes about sleep, and mental health

3 months

1 visit (virtual) at 3-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Course

Trial Overview The study tests the Sleep Course—an internet-delivered cognitive behavioural therapy program for insomnia (ICBTi). The effectiveness and acceptability of this course will be evaluated within a routine online therapy setting in Australia.

How Is the Trial Designed?

Group I: ICBT for insomnia Experimental Treatment 1 Intervention

Therapist-guided, Internet-delivered cognitive behavioral therapy for insomnia (ICBTi)

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Macquarie University, Australia

Collaborator

Trials

27

Recruited

27,100+

Published Research Related to This Trial

Cognitive Behavioral Therapy for insomnia (CBTi) is an effective alternative to medication for treating insomnia, which affects up to 30% of adults, and has been shown to improve various sleep-related outcomes such as sleep onset latency and sleep quality.

CBTi includes techniques like sleep hygiene and cognitive therapy, making it a safe and beneficial option for both adults and adolescents, although access to this therapy can be limited by certain barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. Haynes, J., Talbert, M., Fox, S., et al.[2018]

Cognitive Behavioral Therapy for Insomnia (CBTI) is the preferred treatment for chronic insomnia, but many patients opt for medication due to cost and availability issues.

Internet-based CBTI (I-CBTI) is well-accepted by patients and significantly improves insomnia symptoms, suggesting it could be a valuable alternative for those unable to access traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2020]

The HUS Helsinki University Hospital-iCBT for Insomnia program demonstrated significant effectiveness in treating insomnia, with 75.4% of the 2,464 patients completing the treatment and an average decline of 7.04 points on the Insomnia Severity Index (ISI).

A large proportion of participants (34.0%) achieved remission by the end of the treatment, and the effect size was substantial (Cohen's d = -1.449), indicating that this publicly funded, therapist-supported program is effective in routine care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile-delivered, therapist-assisted cognitive behavioral therapy for insomnia in nationwide routine clinical care in Finland. Stenberg, JH., Ritola, V., Joffe, G., et al.[2023]

Internet-based cognitive-behavioral therapy for insomnia (ICBT-i) significantly improves sleep outcomes in adults, with participants experiencing a decrease in sleep onset latency by 18.41 minutes and an increase in total sleep time by 22.30 minutes based on a meta-analysis of 15 studies involving 1013 participants.

ICBT-i also enhances sleep efficiency by 9.58% and reduces wake after sleep onset by 22.31 minutes, demonstrating its effectiveness as a treatment for insomnia that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. Ye, YY., Chen, NK., Chen, J., et al.[2019]

Both internet-based cognitive behavioral treatments for insomnia (MCT and SRT) were significantly more effective than care as usual, with MCT showing a large effect size for insomnia severity (Cohen's d = -1.15) after eight weeks.

Participants in the multi-component treatment (MCT) reported higher satisfaction compared to those in the sleep restriction treatment (SRT), although both treatments had similar efficacy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia. Krieger, T., Urech, A., Duss, SB., et al.[2020]

A study involving 181 adults with insomnia found that unguided internet-delivered cognitive-behavioral therapy for insomnia (ICBTi) significantly reduced symptoms of anxiety and depression, with medium to large effect sizes after a nine-week treatment period.

While the short-term benefits of ICBTi on psychological symptoms were evident, caution is advised regarding long-term effects due to high dropout rates and lack of control group data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive-behavioral therapy for insomnia and comorbid symptoms. Hagatun, S., Vedaa, Ø., Harvey, AG., et al.[2022]

Internet-based cognitive behavioral therapy for insomnia (I-CBTI) is a highly acceptable treatment option that significantly improves insomnia symptoms for patients who may not have access to traditional CBTI.

The effectiveness of I-CBTI can vary based on specific treatment characteristics and individual patient factors, suggesting that tailoring the approach could enhance outcomes for different patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2019]

A pilot study involving 15 university staff members showed that an online cognitive behavioral therapy for insomnia (iCBT-I) training was well accepted and helpful, with 78% of participants reporting reduced sleep problems after the training.

Before the training, 89% of participants had sleep issues, but after completing the iCBT-I program, 56% achieved clinically significant improvement, and 44% were classified as healthy sleepers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modularized iCBT‑I self-learn training for university staff-prevention and early intervention in the SARS-CoV-2 crisis: A pilot study. Schlarb, AA., Fründ, JP., Kovacevic, T., et al.[2022]

A web-based training course for Cognitive Behavioral Therapy for Insomnia (CBT-I), called CBTIweb.org, was developed and evaluated, showing high usability and significant knowledge gains among participants, with a knowledge increase from 69% to 92% correct after training.

The effectiveness of CBTIweb.org was found to be equivalent to traditional in-person workshops, suggesting it can effectively train behavioral health providers in CBT-I, thus addressing the shortage of trained professionals and allowing for broader access to insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. Taylor, DJ., Dietch, JR., Pruiksma, K., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26615572/

Efficacy of internet-delivered cognitive-behavioral therapy ... Results showed that eCBT-I improved insomnia severity, sleep efficiency, subjective sleep quality, wake after sleep onset, sleep onset latency, total sleep ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

Internet-delivered Cognitive Behavioral Therapy for Insomnia A meta-analysis by Robert Zachariae et al. confirmed that eCBT-I significantly improves insomnia severity, sleep efficiency, sleep quality, ...

3. jmir.org jmir.org/2022/4/e29258/

Internet-Delivered Cognitive Behavioral Therapy for ... This randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0149139

Internet-Delivered Cognitive Behavioral Therapy to Treat ... Internet-delivered cognitive behavioral therapy resulted in a decrease in the insomnia severity index by 4.3 points (95% CI: -7.1, -1.5; p = 0. ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10186

Effectiveness of mobile-delivered, therapist-assisted cognitive ... Study Impact: As many as 75.4% completed the treatment, with the Insomnia Severity Index (ISI) scores declining, on average, by –7.04 points.

6. sciencedirect.com sciencedirect.com/science/article/pii/S221478292400071X

The Sleep Course: An inclusive trial examining ... The intervention was associated with good rates of satisfaction (79 %) and lesson completion (70 %). Results showed significant and large reductions in insomnia ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06745349/the-sleep-course-an-online-sleep-intervention-for-adults-with-self-reported-sleep-difficulties

an Online Sleep Intervention for Adults with Self-reported ... This study evaluates an internet-delivered cognitive behavioural therapy for insomnia (ICBTi) intervention, known as the Sleep Course,

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8365455/

Internet-delivered CBT intervention (Space for Sleep) for ... The program Space for Sleep is an internet-delivered CBT-based intervention for insomnia composed of five core modules, plus one unlockable module on sleep ...

9. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624001207505

ANZCTR - Registration It is based on the principles of cognitive behavioural therapy for insomnia (CBT-I). It runs for 8 weeks and consists of: (a) 4 online lessons with exercises ...

10. aasm.org aasm.org/digital-cognitive-behavioral-therapy-for-insomnia-platforms-and-characteristics/

Digital cognitive behavioral therapy for insomnia The AASM recommends clinicians use cognitive behavioral therapy for insomnia (CBT-I) as first-line treatment for chronic insomnia in adults. ...