Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001207505p
Ethics application status
Submitted, not yet approved
Date submitted
3/09/2024
Date registered
1/10/2024
Date last updated
1/10/2024
Date data sharing statement initially provided
1/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of an online digital cognitive behavioural therapy (CBT) intervention for adults with insomnia
Scientific title
The Sleep Course: timing and magnitude of symptom change in a randomised controlled trial of internet-delivered cognitive behavioural therapy for adults with insomnia
Secondary ID [1] 312875 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study is a follow-up study of the record: ACTRN12623000331639

Health condition
Health condition(s) or problem(s) studied:
Insomnia disorder 335024 0
Condition category
Condition code
Mental Health 331533 331533 0 0
Other mental health disorders
Neurological 331803 331803 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, the Sleep Course, is a digital psychological self-management program. It is based on the principles of cognitive behavioural therapy for insomnia (CBT-I). It runs for 8 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 2, 3, 5, and 7. Lessons can be viewed in the online platform or downloaded as PDF files. Lessons are delivered via an online learning management system in the form of powerpoint-style lessons (i.e., written materials and supporting images). Lessons can also be downloaded as PDFs. Lessons are accompanied by DIY 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. In the first week of the course, participants will receive a welcome email that provides log-in details and requests that participants complete a sleep diary each night for 7 nights. No therapeutic material is released while participants complete their sleep diaries. The first lesson (in week 2) 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 3) 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 5) 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 7) 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. Participants are able to access the course materials during the post-treatment phase, as well as for 3 months after completing the course.
(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, which are available for download as PDF files. These resources provide information about different problems relevant to people with sleep difficulties. These include understanding more about prescription sleeping medications, managing shift-work, information about nightmares, and managing worry and rumination. The additional resources are made available on the course homepage for download. In each lesson, the introductory slides (e.g., 'overview of this lesson' contains a brief text box that provides detail about what is in the additional resources).

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 clinical 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.
Intervention code [1] 329414 0
Behaviour
Comparator / control treatment
The control group is a sleep hygiene waitlist control. Participants will be provided with one lesson containing sleep hygiene advice (e.g., optimising sleep environment, reducing alcohol and caffeine intake, going to bed and waking up at the same time each day). The lesson is approximately 20 minutes in duration, and delivered via an online learning platform in powerpoint format (i.e., text and accompanying images on slides). The lesson is accompanied by a purpose-built self-monitoring checklist that participants can use to track their implementation of sleep hygiene strategies. After the primary treatment phase, participants in the sleep hygiene waitlist control will receive access to the Sleep Course treatment as described above.
Control group
Active

Outcomes
Primary outcome [1] 339280 0
Insomnia Severity
Timepoint [1] 339280 0
Week 1 (pre-treatment) and weekly until Week 8 (post-completion of program; primary endpoint).
Secondary outcome [1] 439352 0
Fatigue
Timepoint [1] 439352 0
Participants will complete the FFS in week 1 and week 8 of the intervention.
Secondary outcome [2] 439356 0
Insomnia Response
Timepoint [2] 439356 0
The ISI will be completed in week 1 and week 8 of the intervention.
Secondary outcome [3] 439357 0
Insomnia Remission
Timepoint [3] 439357 0
Participants' ISI scores at week 8 will be used to calculate insomnia remission.
Secondary outcome [4] 439985 0
Sleep onset latency (SOL; sleep diary)
Timepoint [4] 439985 0
Week 1 (pre-treatment) and Week 8 (post-completion of program)
Secondary outcome [5] 439986 0
Wake after sleep onset (WASO; sleep diary)
Timepoint [5] 439986 0
Week 1 (pre-treatment) and Week 8 (post-completion of program)
Secondary outcome [6] 439987 0
Sleep efficiency (SE; sleep diary)
Timepoint [6] 439987 0
Week 1 (pre-treatment) and Week 8 (post-completion of program)
Secondary outcome [7] 439988 0
Total sleep time (TST; sleep diary)
Timepoint [7] 439988 0
Week 1 (pre-treatment) and Week 8 (post-completion of program)
Secondary outcome [8] 439989 0
SOL (PSQI)
Timepoint [8] 439989 0
Week 1 (pre-treatment) and Week 8 (post-completion of program)
Secondary outcome [9] 439990 0
SE (PSQI)
Timepoint [9] 439990 0
Week 1 (pre-treatment) and weekly until Week 8 (post-completion of program).
Secondary outcome [10] 439991 0
TST (PSQI)
Timepoint [10] 439991 0
Week 1 (pre-treatment) and weekly until Week 8 (post-completion of program).
Secondary outcome [11] 439992 0
Anxiety (GAD-2)
Timepoint [11] 439992 0
Week 1 (pre-treatment) and weekly until Week 8 (post-completion of program).
Secondary outcome [12] 439993 0
Depression (PHQ-2)
Timepoint [12] 439993 0
Week 1 (pre-treatment) and weekly until Week 8 (post-completion of program).
Secondary outcome [13] 439994 0
Anxiety (GAD-7)
Timepoint [13] 439994 0
Week 1 (pre-treatment) and Week 8 (post-completion of program).
Secondary outcome [14] 439995 0
Depression (PHQ-9)
Timepoint [14] 439995 0
Week 1 (pre-treatment) and Week 8 (post-completion of program).
Secondary outcome [15] 439996 0
Cognitive arousal (PSAS)
Timepoint [15] 439996 0
Week 1 (pre-treatment) and Week 8 (post-completion of program)
Secondary outcome [16] 439997 0
Somatic arousal (PSAS)
Timepoint [16] 439997 0
Week 1 (pre-treatment) and Week 8 (post-completion of program)

Eligibility
Key inclusion criteria
1. Currently living in Australia
2. Aged 18 or older
3. Report clinically significant insomnia: symptoms on the ISI > 10, duration > 1 month and report that the difficulties are causing distress or causing the individual problems at work, socially, or in another important way.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current severe medical or psychiatric disorder that requires medical treatment (e.g., current active substance use disorder, mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment)
2. Evidence of an undiagnosed and untreated sleep disorder (e.g., restless legs syndrome, sleep apnoea) that is the primary cause of insomnia symptoms.
3. Actively suicidal or unable to keep themselves safe.
4. 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)
The randomisation schedule will be held by an investigator not involved in assessment of participants. The study clinicians who confirm eligibility with participants will therefore be unaware of participants' allocation until after eligibility has been confirmed. After this point, the study clinician will contact the holder of the allocation schedule to confirm enrolment and determine the participants' allocation status.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 to treatment and sleep hygiene waitlist control. Randomisation will occur using a computer-generated randomisation sequence (using www.random.org) by an independent researcher not involved in the recruitment of participants. Participants will be randomised in blocks of six and will also be stratified based on ISI score (< 15, and >/= 15).
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
Efficacy analyses will be carried out using intention-to-treat principles and longitudinal modelling. Specifically, Generalized Estimating Equations (GEE) will be used to analyse the change in outcome measures across time between groups.

GEE analyses will also be used to model symptom change over time. Pairwise comparisons will be used to examine change in symptom scores between consecutive time-points.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2024
Actual
Date of last participant enrolment
Anticipated
16/10/2026
Actual
Date of last data collection
Anticipated
11/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317316 0
University
Name [1] 317316 0
Macquarie University Research Fellowship
Country [1] 317316 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 319598 0
None
Name [1] 319598 0
Address [1] 319598 0
Country [1] 319598 0
Other collaborator category [1] 283174 0
Other Collaborative groups
Name [1] 283174 0
Woolcock Institute of Medical Research
Address [1] 283174 0
Country [1] 283174 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316048 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 316048 0
Ethics committee country [1] 316048 0
Australia
Date submitted for ethics approval [1] 316048 0
18/07/2024
Approval date [1] 316048 0
Ethics approval number [1] 316048 0

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

Contacts
Principal investigator
Name 136610 0
Dr Amelia Scott
Address 136610 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 136610 0
Australia
Phone 136610 0
+61 02 9850 8602
Fax 136610 0
Email 136610 0
[email protected]
Contact person for public queries
Name 136611 0
Amelia Scott
Address 136611 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 136611 0
Australia
Phone 136611 0
+61 02 9850 8602
Fax 136611 0
Email 136611 0
[email protected]
Contact person for scientific queries
Name 136612 0
Amelia Scott
Address 136612 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 136612 0
Australia
Phone 136612 0
+61 02 9850 8602
Fax 136612 0
Email 136612 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 principal 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.