Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000660886
Ethics application status
Approved
Date submitted
7/04/2021
Date registered
31/05/2021
Date last updated
31/05/2021
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Sleep Course: a randomised controlled trial of an online transdiagnostic sleep intervention for adults with sleep difficulties
Scientific title
The Sleep Course: a randomised controlled trial of an online transdiagnostic sleep intervention for adults with sleep difficulties
Secondary ID [1] 303809 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep difficulties 321311 0
Insomnia 321312 0
Condition category
Condition code
Mental Health 319099 319099 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, the Sleep Course, is an internet-delivered self-management program. It runs for 6 weeks and consists of:
(a) 4 online lessons with exercises for learning the information and skills. The duration of each lesson is approximately 20 to 30 minutes. Lessons are completed in weeks 1, 2, 4, and 5. Lessons can be viewed in the online platform or downloaded as PDF files. Lessons are accompanied by lesson worksheets which can be downloaded and/or printed as PDF files. Participants are encouraged to engage with the home-based exercises at a frequency and duration that is helpful for them, though a suggested time commitment of at least 30 minutes each week is encouraged. The first lesson (in week 1) is an introduction to the course and overview of the key processes that govern sleep-wake cycles. This includes the circadian rhythm (or body clock) and the sleep pressure system. Participants are encouraged to consider the relevance of these two systems for their unique situation as a home-based exercise. Lesson 2 (week 2) introduces two key behavioural methods to improve sleep – stimulus control and sleep restriction therapy. Participants are also provided with a decision-making tool to determine which strategy they may use. As home-based exercise, participants are encourage to start practicing one of these skills for the next two weeks. Lesson 3 (week 4) introduces the cognitive behavioural model, and explores how thinking processes and appraisals can influence sleep. For their home-based exercises, participants are encouraged to practice cognitive challenging skills. Finally, Lesson 4 (week 5) introduces strategies to manage sleep difficulties during the day. It covers the importance of helpful daytime habits to promote sleep at night, including overcoming sleep inertia, remaining active during the day, and implementing a wind-down routine. Participants are encouraged to experiment with symptoms of fatigue as home-based work, as well as to introduce wake-up and wind-down routines.
(b) Automatic emails that help guide people through the course. Examples of these e-mails include; reminders when new lessons are available, congratulatory messages once a lesson has been completed, brief messages that reinforce the core concepts of the lessons, and e-mails inviting contact and encouraging engagement if a participant has not logged in for a while. E-mails are sent approximately once per week.
(c) Additional Resources developed specifically for this study. These resources provide information about different problems relevant to people with sleep difficulties. These include managing shift-work, information about nightmares, and managing worry and rumination. The additional resources are made available on the course homepage for download.

Participants will also have the option of support from a psychologist as they work through the course, either via telephone or secure personal messaging. Course psychologists will contact participants via secure message in the first week of the course, to obtain participant preferences regarding the frequency and nature of contact. After this point, psychologists will tailor their communication to the participants' preferences. All psychologists will be nationally registered and employed by Macquarie University or one of its entities (e.g., MQ Health). All psychologists will be provided with training and supervision from a senior psychologist to ensure competence and safety in their practice.

Adherence with the intervention is monitored via the study's secure web platform, which records information such as; the number of participant log-ins, lesson completions; time spent completing each lesson; and number of downloads of additional resources.

A second group will be randomised to a minimal intervention waitlist control (MIWLC) group. Participants in the MIWLC condition will receive brief psychoeducational materials in the first week of the course only. These are purpose-built psychoeducational materials that cover information similar to that in Lesson 1 of the course (information about the circadian rhythm and the sleep pressure system, and brief sleep hygiene tips.) The materials are delivered within the course webpage, as lessons that can be viewed online and downloaded. Participants in the MIWLC will be offered access to the full intervention after 8 weeks.
Intervention code [1] 320116 0
Behaviour
Intervention code [2] 320117 0
Treatment: Other
Comparator / control treatment
The study will utilise a traditional waitlist control. Those in the waitlist control will not have access to treatment for the duration of the primary treatment period (8 weeks), after which they will commence the Sleep Course.
Control group
Active

Outcomes
Primary outcome [1] 326993 0
Self-reported sleep disturbance, measured by the Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Scale (PROMIS-SD).
Timepoint [1] 326993 0
Post-treatment (8-weeks post baseline period)
Secondary outcome [1] 393400 0
Lesson completion (i.e. 0 to 4 lessons), will be assessed by obtaining website analytics that report participant completion of each lesson.
Timepoint [1] 393400 0
Post-treatment (8-weeks post baseline period)
Secondary outcome [2] 393401 0
Self-reported sleep disturbance, measured by the Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Scale (PROMIS-SD).
Timepoint [2] 393401 0
3-months post-intervention completion
Secondary outcome [3] 393402 0
Sleep-related impairment (PROMIS-SRI)
Timepoint [3] 393402 0
Post-treatment (8-weeks post baseline period), 3-months post-intervention completion
Secondary outcome [4] 393403 0
Insomnia Severity (ISI)
Timepoint [4] 393403 0
Post-treatment (8-weeks post baseline period), 3-months post-intervention completion
Secondary outcome [5] 393404 0
Participants' sleep-wake parameters, recorded via sleep diary (CSD)
Timepoint [5] 393404 0
Post-treatment (8-weeks post baseline period)
Secondary outcome [6] 393405 0
Beliefs and attitudes towards sleep (DBAS-16)
Timepoint [6] 393405 0
Post-treatment (8-weeks post baseline period)
Secondary outcome [7] 393406 0
Depression symptoms (PHQ-9)
Timepoint [7] 393406 0
Post-treatment (8-weeks post baseline period), 3-months post-intervention completion
Secondary outcome [8] 393407 0
Anxiety symptoms (GAD-7)
Timepoint [8] 393407 0
Post-treatment (8-weeks post baseline period), 3-months post-intervention completion
Secondary outcome [9] 396298 0
Rate of drop-out (the proportion of participants who do not return outcome data at post-treatment).
Timepoint [9] 396298 0
Post-treatment (8-weeks post baseline period)
Secondary outcome [10] 396299 0
Treatment satisfaction (assessed using a 5-point likert scale ranging from 'very dissatisfied' to 'very satisfied'.)
Timepoint [10] 396299 0
Post-treatment (8-weeks post baseline period)

Eligibility
Key inclusion criteria
(a) Self-reported difficulty with sleep (i.e. difficulty falling or staying asleep) or sleep-related daytime impairment;
(b) Sleep difficulties are causing distress or causing the individual problems at work, socially, or in another important way;
(c) Are aged 18 years or older;
(d) Willingness to learn information and skills to self-manage sleep difficulties.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Current severe medical or psychiatric disorder that requires immediate treatment (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment);
(b) Living outside of Australia;
(c) Unable to read and understand English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online via the clinic's website (www.ecentreclinic.org.au). Successful applications are followed by a telephone interview to confirm suitability for the trial. Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org) using permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study will be powered to detect a moderate effect size of d = 0.6 between treatment and WLC, and an effect of d = 0.5 between treatment and MIWLC. This assumption is based on studies examining online CBT for insomnia disorder and those examining CBT interventions among broader populations of individuals with sleep difficulty. With statistical power of 0.8 and alpha set at .05, we require 60 participants per treatment arm. This accounts for 15% attrition in each group.

Efficacy analysis will be conducted using generalised estimating equations (GEE). All primary and secondary outcomes will be analysed in treatment and control groups separately. Estimated marginal means provided by GEE analysis (and 95% CIs) from pre- to post-treatment will be compared between groups. Subgroup analysis will be conducted among participants scoring above clinical cut-off on the PROMIS-SD and ISI.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/07/2021
Actual
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
1/11/2022
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308207 0
University
Name [1] 308207 0
Macquarie University
Country [1] 308207 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 308994 0
None
Name [1] 308994 0
Address [1] 308994 0
Country [1] 308994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308188 0
Macquarie University Medical Sciences Human Research Ethics Committee
Ethics committee address [1] 308188 0
Ethics committee country [1] 308188 0
Australia
Date submitted for ethics approval [1] 308188 0
19/03/2021
Approval date [1] 308188 0
28/05/2021
Ethics approval number [1] 308188 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109858 0
Dr Amelia Scott
Address 109858 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 109858 0
Australia
Phone 109858 0
+61 2 98508602
Fax 109858 0
Email 109858 0
[email protected]
Contact person for public queries
Name 109859 0
Amelia Scott
Address 109859 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 109859 0
Australia
Phone 109859 0
+61 2 98508602
Fax 109859 0
Email 109859 0
[email protected]
Contact person for scientific queries
Name 109860 0
Amelia Scott
Address 109860 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 109860 0
Australia
Phone 109860 0
+61 2 98508602
Fax 109860 0
Email 109860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.
When will data be available (start and end dates)?
Data will be made after any original reports have been published. There will be no end date to the availability.
Available to whom?
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
How or where can data be obtained?
Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Data can be obtained by e-mailing the pincipal investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.