InsomniaNCT06745349
The Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties
A study testing Sleep Course in people with Insomnia and Depression, run by University of Regina at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Depression, Anxiety
- What is being tested?
- Sleep Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Online Therapy Unit
Regina, Saskatchewan, S4S 0A2
Marcie M Nugent, MSW, 306-337-2946, marcie.nugent@uregina.ca
Heather D Hadjistavropoulos, PhD, 306-585-5133, heather.hadjistavropoulos@uregina.ca
About this study
Official title: The Sleep Course: Examining the Feasibility, Acceptability, and Effectiveness of an Online Sleep Intervention for Adults With Self-reported Sleep Difficulties
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.
Read the 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
- Being tested
- Sleep Course
- Keywords
- Internet, Internet-Delivered CBT, Digital Mental Health Interventions, Insomnia, Sleep Difficulties, Depression, Anxiety
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep CourseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ICBT for insomnia | Experimental | Therapist-guided, Internet-delivered cognitive behavioral therapy for insomnia (ICBTi) Receives: Behavioral: Sleep Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening, weeks 1, 2, 3, 4, 5, 6, 7 (post-treatment), and 3-month follow-up
Secondary outcomes (12)
Change in sleep diary scores
The core Consensus Sleep Diary (CSD) consisting of 9 items, will be administered to clients each morning for 7 consecutive days, asking about their sleep the previous night. Participants will record the time they went to bed, time to initiate sleep, time they woke up in the morning, time of final awakening, and time they got out of bed in the morning (in clock). Participants will also record the number (in numbers) and duration of awakenings during the night (in minutes). Using a 6-point Likert scale ranging from 0 to 5, participants will indicate the quality of their sleep with higher scores indicating more restorative sleep quality. An additional open-ended item is added for comments. Two extra questions on napping-extracted from the Expanded Consensus Sleep Diary for Morning- will be included. Using this, participants will record if they napped the previous day (yes/no), and for how long (in minutes). There is no overall score for the scale, each parameter is analyzed separately.
Measured: Baseline and week 7 (post treatment)
Change in sleep quality
Pittsburgh Sleep Quality Index (PSQI). A 19-item survey rated on a 0 to 3-point scale. This survey is used to assess sleep dysfunction over the past month and produces scores for subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of medication, daytime dysfunction, and higher scores indicate severe difficulties in each area. A sum of the scores from these factors produces a global score between 0-21, where higher global scores indicate more severe sleep disturbances.
Measured: Screening, week 7 (post treatment) and 3-month follow-up
Change in sleep quality
Pittsburgh Sleep Quality Index (PSQI- 4 Items). A 4-item survey that assesses quality of sleep. Items on this scale are measured on a 4-point Likert scale ranging from 0-3, and scores range from 0-12, with higher scores indicating worse sleep quality. This measure is used by clinicians to monitor client sleep.
Measured: Weeks 1, 2, 3, 4, 5, and 6
Change in attitudes and beliefs about sleep
Dysfunctional Beliefs and Attitudes about Sleep- 16 item (DBAS-16) with items rated on a 0 to 10-point scale. Scores range from 0 to 160 with higher scores indicating greater dysfunctional beliefs about sleep.
Measured: Screening, week 7 (post-treatment) and 3-month follow-up
Change in depression
Patient Health Questionnaire - 9 Item (PHQ-9). Includes 9 items rated 0 to 3. Higher total scores indicate greater severity of depression. Scores range from 0 to 27. Clinical cutoff of ≥10 indicate clinically significant depression.
Measured: Screening, week7 (post treatment) and 3-month follow-up
Change in depression and anxiety
Patient Health Questionnaire - 4 Item (PHQ-4) involves rating 4 items on a scale from 0 to 3, with scores ranging from 0 to 12. Higher total scores indicate greater severity of depression and anxiety symptoms. Additionally, item #9 of the PHQ-9 is presented alongside the PHQ-4 to monitor client's wellbeing. This item is rated on a scale from 0 to 3, with higher scores indicating more severe self-harm or suicidal ideology. However, the score from this item is not included in the overall PHQ-4 score. This measure is used by clinicians to monitor client's mental health symptoms.
Measured: Weeks 1, 2, 3, 4, 5, and 6
Change in anxiety
Generalized Anxiety Disorder - 7 Item (GAD-7). Includes 7-items used to assess generalized anxiety disorder. Items are rated on a 0 to 3-point Likert scale. Total score range from 0 to 21, and higher total scores indicate greater severity of anxiety. Clinical cutoff of ≥10 indicates clinically significant anxiety.
Measured: Screening, week 7 (post treatment) and 3-month follow-up
Lesson reflection
Lesson reflection questionnaire - A bespoke 6-item survey that inquires about which lesson and resources clients worked on, effort, understanding, helpfulness, and client successes and challenges over the previous week. This survey is used for clinicians to monitor treatment. No score is calculated or created.
Measured: Weeks 2, 3, 4, 5, 6, and 7 (post treatment)
Evaluation of treatment
Treatment Satisfaction Survey. A bespoke questionnaire consisting of 15 items with varying response formats measuring treatment satisfaction. The questionnaire utilizes a combination of Likert-scale (5-point (0-4)and 6-point (0-5) ), open-ended, and dichotomous yes/no response options to gauge participants' perception of the course. No overall score is calculated or reported for this questionnaire.
Measured: Week 7 (post treatment)
Engagement
The system collects information on number of lessons completed, number of additional resources accessed, number of emails sent to and received from therapist. Participants' engagement is calculated by averaging the sum from all of the components listed above.
Measured: Collects engagement from time of consent to 3 month follow-up
Background Information
Background information including demographic questions will be collected at screening for descriptive purposes. No scores are calculated.
Measured: Screening
Sleep history & treatment history
Sleep and treatment history questions will be administered at screening for descriptive purposes. No scores are calculated based on these questions.
Measured: Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start10 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Macquarie University, Australia
- Responsible party
- Sponsor
- Investigators
- Heather D Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745349
- Sponsor's protocol ID
- 873
- Status last verified
- Nov 2026
- First submitted
- 17 Dec 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sleep Course: Examining the Feasibility, Acceptability, and Effectiveness of an Online Sleep Intervention for Adults With Self-reported Sleep Difficulties
- ClinicalTrials.gov ID
- NCT06745349
- Acronym / sponsor ID
- 873
- Conditions
- Insomnia, Depression, Anxiety
- Keywords
- Internet, Internet-Delivered CBT, Digital Mental Health Interventions, Insomnia, Sleep Difficulties, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Macquarie University, Australia
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICBT for insomnia | Experimental | Behavioral: Sleep CourseTherapist-guided, Internet-delivered cognitive behavioral therapy for insomnia (ICBTi) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep CourseThe 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. | Behavioural | ICBT for insomnia |
Primary outcome
Change in insomnia symptoms
Time frame: Screening, weeks 1, 2, 3, 4, 5, 6, 7 (post-treatment), and 3-month follow-up
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.
12 secondary outcomes
Change in sleep diary scores
Time frame: Baseline and week 7 (post treatment)
Change in sleep quality
Time frame: Screening, week 7 (post treatment) and 3-month follow-up
Change in sleep quality
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Change in attitudes and beliefs about sleep
Time frame: Screening, week 7 (post-treatment) and 3-month follow-up
Change in depression
Time frame: Screening, week7 (post treatment) and 3-month follow-up
Change in depression and anxiety
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Change in anxiety
Time frame: Screening, week 7 (post treatment) and 3-month follow-up
Lesson reflection
Time frame: Weeks 2, 3, 4, 5, 6, and 7 (post treatment)
Evaluation of treatment
Time frame: Week 7 (post treatment)
Engagement
Time frame: Collects engagement from time of consent to 3 month follow-up
Background Information
Time frame: Screening
Sleep history & treatment history
Time frame: Screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Helpful Links Provided by University of ReginaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather D Hadjistavropoulos, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Course in people with Insomnia and Depression, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcie Nugent, MSW (306-337-2946, marcie.nugent@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.