The Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties

NCT ID: NCT06745349

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed Description

To improve access to effective psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has been developed. ICBT delivers therapeutic content via structured online lessons usually over several months, teaching the same skills that are taught in face-to-face cognitive behaviour therapy. In routine practice, ICBT is often accompanied by brief therapist support offered via secure messaging and/or phone calls. A growing body of research supports the effectiveness of ICBT for a variety of conditions, including depression, anxiety, alcohol misuse, and insomnia. For insomnia, ICBTi has been shown to result in improvements on various sleep measures, comorbid anxiety and depression, and quality of life, with outcomes comparable to face-to-face treatment.

Importantly, there are a growing number of studies showing the effectiveness of ICBT for depression and anxiety extends to routine care. However, there are fewer studies exploring ICBTi in routine care, particularly when minimal exclusion criteria are imposed. This research is important because sleep difficulties and insomnia are common, distressing and often disabling and frequently comorbid with mood or anxiety disorders as well as various physical conditions. Moreover, access to specialized psychological services, such as CBTi, is often limited, despite CBTi being a well-established first-line treatment, which many clients find more acceptable than medication. Two key aspects of CBTi are stimulus control and sleep restriction though other strategies such as cognitive restructuring and relaxation are also commonly included. ICBTi offers a promising approach for expanding access to evidence-based treatment for insomnia. This is especially critical given the high personal and societal costs of leaving insomnia untreated.

From past research, the investigators have found that approximately 73% of clients enrolled in the routine clinic that offers ICBT for anxiety and depression also reported significant sleep problems. Of these, only 30% accessed an additional sleep resource to address their sleep concerns. While improvements in sleep were observed among all clients enrolled in ICBT, average post-test treatment scores indicated many clients still had significant difficulties with insomnia. In another study conducted within the investigators' Unit, the investigators explored whether offering an insomnia-focussed lesson at the beginning of ICBT would improve insomnia symptoms. In this study, the investigators found that clients experienced large reductions in insomnia symptoms at a faster rate than when clients did not receive the insomnia lesson at the beginning of ICBT. However, even with these improvements, many clients continued to report clinically significant levels of insomnia post-treatment, indicating that further support for insomnia symptoms may be beneficial.

Overall, given that the investigators ICBT program does not appear to be fully meeting the sleep needs of clients who have depression and anxiety, as well as the needs of clients who have sleep problems or insomnia and do not want ICBT for depression and anxiety, the investigators believe it would be valuable to explore the benefits of offering ICBTi in the routine care clinic. This is especially important for routine care settings where inclusivity is key and services should be broadly accessible.

One such program that shows promise among clients with diverse sleep difficulties is the Sleep Course. The current study therefore aims to explore the extent to which this ICBTi program will be used by clients seeking services within the routine online clinic. Additionally, the study will explore the demographic and clinical characteristics of clients who seek ICBTi, as well as the acceptability and effectiveness of the ICBTi program. The data collected will shape long-term practices within the Online Therapy Unit and has potential to significantly enhance service delivery. The research will also provide valuable insights for other online clinics regarding the potential of offering ICBTi in routine online care. By exploring the program's use, client characteristics, acceptability, and effectiveness, this study will contribute to a broader understanding of how ICBTi can be successfully integrated into routine online services, ultimately improving access to evidence-based treatment for insomnia.

Conditions

Insomnia; Depression; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICBT for insomnia

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

Group Type: EXPERIMENTAL

Sleep Course

Intervention Type: BEHAVIORAL

The Sleep Course previously developed and evaluated in Australia will be delivered to clients meeting participation criteria. The Sleep Course is four lessons long and is offered with once weekly therapist support for 8 weeks where clients are encouraged to email the assigned therapist for support each week. The therapist reviews client progress in the Course and emails clients once per week on a designated check in date. Sometimes the therapist will call the client. Phone calls are typically made if a client is not logging in or if the therapist feels that a phone call would be a helpful way to provide support.

Interventions

Sleep Course

The Sleep Course previously developed and evaluated in Australia will be delivered to clients meeting participation criteria. The Sleep Course is four lessons long and is offered with once weekly therapist support for 8 weeks where clients are encouraged to email the assigned therapist for support each week. The therapist reviews client progress in the Course and emails clients once per week on a designated check in date. Sometimes the therapist will call the client. Phone calls are typically made if a client is not logging in or if the therapist feels that a phone call would be a helpful way to provide support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years or older;
• Living in Saskatchewan for the treatment period;
• Self-reported difficulty with sleep (i.e., difficulty falling, staying asleep or waking up early) causing daytime distress and or impairment;
• Has comfort using and access to a device or computer with Internet in a private location;
• Read and understand English;
• Consent to Sleep Course, online therapy as provided by Unit, and associated research.

Exclusion Criteria

• Current severe medical or psychiatric disorder that requires immediate or alternate treatment (e.g. current and recent mania or psychosis requiring hospitalization, actively suicidal and unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment, severe substance use);
• Taking part in another treatment at our clinic.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Macquarie University, Australia

OTHER

Sponsor Role: collaborator

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather D Hadjistavropoulos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

Online Therapy Unit

Regina, Saskatchewan, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marcie Nugent, MSW

Role: CONTACT

marcie.nugent@uregina.ca

306-337-2946

Heather Hadjistavropoulos, PhD

Role: CONTACT

heather.hadjistavropoulos@uregina.ca

306-585-5133

Facility Contacts

Marcie M Nugent, MSW

Role: primary

marcie.nugent@uregina.ca

306-337-2946

Heather D Hadjistavropoulos, PhD

Role: backup

heather.hadjistavropoulos@uregina.ca

306-585-5133

Related Links

https://www.onlinetherapyuser.ca/

Helpful Links Provided by University of Regina

Other Identifiers

873

Identifier Type: -

Identifier Source: org_study_id