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

NCT06745349 | Recruiting

• 1 other identifier: 873
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Insomnia; Depression

Keywords

Internet; Internet-Delivered CBT; Digital Mental Health Interventions; Insomnia; Sleep Difficulties; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in insomnia symptoms

  Insomnia Severity Index (ISI). Includes 7 items rated on a 0 to 4 scale. Higher total scores indicate greater severity of insomnia symptoms over the past two weeks. Scores range from 0 to 28.

  Screening, weeks 1, 2, 3, 4, 5, 6, 7 (post-treatment), and 3-month follow-up

Secondary Outcomes (12)

• Change in sleep diary scores

  Baseline and week 7 (post treatment)

• Change in sleep quality

  Screening, week 7 (post treatment) and 3-month follow-up

• Change in sleep quality

  Weeks 1, 2, 3, 4, 5, and 6

• Change in attitudes and beliefs about sleep

  Screening, week 7 (post-treatment) and 3-month follow-up

• Change in depression

  Screening, week7 (post treatment) and 3-month follow-up

Study Arms (1)

ICBT for insomnia

EXPERIMENTAL

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

Behavioral: Sleep Course

Interventions

Sleep Course 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.

ICBT for insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Regina: lead
• Macquarie University, Australia: collaborator

Study Sites (1)

Online Therapy Unit

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

Related Links

• Helpful Links Provided by University of Regina

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Heather D Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcie Nugent, MSW

CONTACT

306-337-2946; marcie.nugent@uregina.ca

Heather Hadjistavropoulos, PhD

CONTACT

306-585-5133; heather.hadjistavropoulos@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)