The Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Regina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Sleep Course
BehavioralThe 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.
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: ICBT for insomniaExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Screening, weeks 1, 2, 3, 4, 5, 6, 7 (post-treatment), and 3-month follow-upSecondary outcomes
1
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.
Time frame
Baseline and week 7 (post treatment)2
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.
Time frame
Screening, week 7 (post treatment) and 3-month follow-up3
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.
Time frame
Weeks 1, 2, 3, 4, 5, and 64
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.
Time frame
Screening, week 7 (post-treatment) and 3-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Regina
Lead sponsor
Macquarie University, Australia
Collaborator
Source ClinicalTrials.gov