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

Trial Summary

What is the purpose of this trial?

This study evaluates an internet-delivered cognitive behavioural therapy for insomnia (ICBTi) intervention, known as the Sleep Course, within a routine online therapy clinic (the Online Therapy Unit). The Sleep Course will specifically be offered to clients with self-reported sleep difficulties (i.e., falling or staying asleep or waking early) and daytime distress and or impairment. This study aims to replicate the effectiveness and acceptability of the previously evaluated Sleep Course when delivered in Australia. The investigators will also assess uptake and completion rates within the clinic as well as demographic and clinical characteristics of individuals enrolled in the Sleep Course.

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 data supports the effectiveness of the treatment Sleep Course, The Sleep Course, Internet-delivered cognitive behavioural therapy for insomnia (ICBTi)?

Research shows that internet-based cognitive behavioral therapy for insomnia (ICBTi) is effective in improving insomnia symptoms and is generally well-received by patients. It offers a promising alternative to traditional therapy, especially when access to trained professionals is limited. ^{1 2 3 4 5}

Is the online sleep course for insomnia safe for humans?

The online sleep course for insomnia, also known as internet-delivered cognitive behavioral therapy for insomnia (ICBTi), is generally considered safe for humans. It is a non-drug treatment that focuses on improving sleep habits and behaviors, and there are no reports of harmful effects in the studies reviewed. ^{1 3 6 7 8}

How is the Sleep Course treatment for insomnia different from other treatments?

The Sleep Course is unique because it is an online program that uses cognitive behavioral therapy (CBT) techniques specifically designed for insomnia, making it accessible and convenient for users to complete at their own pace from home, unlike traditional in-person therapy sessions. ^{1 2 3 8 9}

Research Team

Heather D Hadjistavropoulos, PhD

Principal Investigator

University of Regina

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. [2021]

2. Netherlands 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. [2019]

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

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]

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

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive-behavioral therapy for insomnia and comorbid symptoms. [2022]

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

Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]

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

Effectiveness of mobile-delivered, therapist-assisted cognitive behavioral therapy for insomnia in nationwide routine clinical care in Finland. [2023]

9. Germany 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. [2022]