Clinical trial NCT06745349: The Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties
Official title: The Sleep Course: Examining the Feasibility, Acceptability, and Effectiveness of an Online Sleep Intervention for Adults With Self-reported Sleep Difficulties
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Depression
Anxiety
Keywords: Internet
Internet-Delivered CBT
Digital Mental Health Interventions
Insomnia
Sleep Difficulties
Depression
Anxiety
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Macquarie University, Australia
First posted: 2024-12-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in insomnia symptoms
timeFrame: Screening, weeks 1, 2, 3, 4, 5, 6, 7 (post-treatment), and 3-month follow-up
Secondary outcomes:
measure: Change in sleep diary scores
timeFrame: Baseline and week 7 (post treatment)
measure: Change in sleep quality
timeFrame: Screening, week 7 (post treatment) and 3-month follow-up
measure: Change in sleep quality
timeFrame: Weeks 1, 2, 3, 4, 5, and 6
measure: Change in attitudes and beliefs about sleep
timeFrame: Screening, week 7 (post-treatment) and 3-month follow-up
measure: Change in depression
timeFrame: Screening, week7 (post treatment) and 3-month follow-up
measure: Change in depression and anxiety
timeFrame: Weeks 1, 2, 3, 4, 5, and 6
measure: Change in anxiety
timeFrame: Screening, week 7 (post treatment) and 3-month follow-up
measure: Lesson reflection
timeFrame: Weeks 2, 3, 4, 5, 6, and 7 (post treatment)
measure: Evaluation of treatment
timeFrame: Week 7 (post treatment)
measure: Engagement
timeFrame: Collects engagement from time of consent to 3 month follow-up
measure: Background Information
timeFrame: Screening
measure: Sleep history & treatment history
timeFrame: Screening
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather D Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: