Recruiting

Sleep Course

Sponsor:

University of Regina

Code:

NCT06745349

Conditions

Insomnia

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sleep Course

Study Details

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

Insomnia

Depression

Anxiety

Study ID

NCT06745349

Start date

Dec 10, 2024

Status verified date

Apr, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

56 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ICBT for insomnia

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

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.

Primary outcome measure

  • Change in insomnia symptoms [ Time Frame: Screening, weeks 1, 2, 3, 4, 5, 6, 7 (post-treatment), and 3-month follow-up ]

Central Contacts and Locations

Central contacts

Marcie Nugent, MSW

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

Heather Hadjistavropoulos, PhD

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

Locations

Online Therapy Unit

Recruiting

Regina, Saskatchewan, Canada, S4S 0A2

Contacts

Marcie M Nugent, MSW

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

Heather D Hadjistavropoulos, PhD

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

Principal Investigator:

Heather D Hadjistavropoulos, PhD

More Information

Sponsor

University of Regina

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2026-04-29.