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Trial registered on ANZCTR


Registration number
ACTRN12621001395820
Ethics application status
Approved
Date submitted
24/07/2021
Date registered
15/10/2021
Date last updated
3/04/2024
Date data sharing statement initially provided
15/10/2021
Date results provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a digital Cognitive Behavioural Therapy for insomnia (dCBTi) on sleep and mental health.
Scientific title
Effect of digital Cognitive Behavioural Therapy for insomnia (dCBTi), versus digital sleep education control, in a community-based sample of adults with insomnia symptoms: A randomised waitlist controlled trial.
Secondary ID [1] 304867 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia disorder 322978 0
Condition category
Condition code
Mental Health 320549 320549 0 0
Other mental health disorders
Neurological 320975 320975 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Digital Cognitive Behavioural Therapy for insomnia (dCBTi).

Rationale: Cognitive behavioural therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia (Qaseem et al., 2016, Ann Intern Med). Very few Australian patients with insomnia ever access CBTi (Miller et al., 2017, JCSM). This project aims to test the effectiveness of a dCBTi intervention in the Australian context.

Type: Non-drug, online, interactive.

Setting/location: Online, any location in Australia.

Duration: 5 x 20 minute online sessions, delivered over 5 consecutive weeks.

Protocol: This program is based on CBTi, the recommended treatment for insomnia (e.g. Qaseem et al., 2016, Ann Intern Med, DOI: 10.7326/M15-2175). It is a digitised version of a brief CBTi protocol described in an scientific article in the Australian Journal of General Practice (Sweetman et al., 2021, AJGP, doi: 10.31128/AJGP-04-20-5391).

Content: Each session will be administered online (computer or mobile phone). Each session will contain videos, text, and images. Participants will be asked to enter text-based, numerical (e.g. minutes of sleep duration) and multiple-choice data throughout the program. Participants will receive tailored therapy recommendations during each weekly session (see Sweetman et al., 2021, Aus J General Practice for tailored therapy recommendations). Immediately after each session is completed, participants will receive an automated follow-up email with session-specific 'follow-up' information and tailored therapy recommendations including recommended bedtime window (approximate reading time: 15 minutes). Participants will receive another automated email one week later with a link to start each subsequent session. Videos are presented by researchers, psychologists, and sleep technicians, each with extensive experience (>8 years) in the management of insomnia.

Tailoring / personalisation: Therapy recommendations will be tailored to participant's insomnia symptoms at baseline and weekly changes in symptoms throughout the program. Bedtime Restriction Therapy (initial restriction of time in bed to consolidate sleep, and subsequent gradual extension of time in bed) is a core component of CBTi. Bedtime restriction recommendations will be tailored to the specific sleep/wake information that participants provide.

Primary therapeutic components: Information about sleep, Bedtime restriction therapy, Stimulus Control Therapy.

Adherence assessment: Adherence will be defined as the number of participants commencing each of the 5 online sessions. This information is automatically collected through the online system.
Intervention code [1] 321256 0
Treatment: Other
Intervention code [2] 321563 0
Behaviour
Comparator / control treatment
Waitlist control for 8 weeks before commencing dCBTi.

Participants in the waitlist condition will receive weekly emails with written information about insomnia and sleep health for the first 5 weeks of the trial. This includes information about;
- 'sleep hygiene' (healthy sleep behaviours)
- sleep myths and facts
- Information about caffeine and sleep
- depression and sleep
- chronic insomnia (symptoms, diagnosis, treatment options)

Each weekly information packet takes approximately 4 minutes to read.
Control group
Active

Outcomes
Primary outcome [1] 328373 0
Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire.
Timepoint [1] 328373 0
Between-group change in ISI scores from baseline to 8-week follow-up (primary timepoint).
Change in ISI scores from baseline to 16-week and 24-week follow-up in the CBTi group.
Secondary outcome [1] 398787 0
Between-group change in self-reported depression symptoms on the Patient Health Questionnaire (PHQ-9).
Timepoint [1] 398787 0
Between-group change in PHQ-9 scores from baseline to 8-week follow-up (primary timepoint).
Change in PHQ-9 scores from baseline to 16-week and 24-week follow-up in the CBTi group.
Secondary outcome [2] 398788 0
Between-group change in self-reported anxiety symptoms on the Generalised Anxiety Disorder (GAD-7) questionnaire.
Timepoint [2] 398788 0
Between-group change in GAD-7 scores from baseline to 8-week follow-up (primary timepoint).
Change in GAD-7 scores from baseline to 16-week and 24-week follow-up in the CBTi group.

Eligibility
Key inclusion criteria
Patient Inclusion Criteria
1. Adults aged great than or equal to 18 years.
2. Reliable access to computer, tablet or smartphone, with internet access
3. Basic English language comprehension as required for dCBTi program
4. An ISI score of at least 15 (Moderate insomnia)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Psychiatric condition (Bi-polar disorder, schizophrenia)
2. Risk of suicide (PHQ-9; item 9 score of greater than or equal to 1)
3. Epilepsy
4. Currently pregnant
5. Drug or alcohol problem
6. Terminal illness
7. Moderate daytime sleepiness (Epworth Sleepiness Scale score equal to or more than 16)
8. People who are commercial drivers or operate heavy machinery for work
9. People with a cognitive impairment
10. Shift workers
11. Previous diagnosis of a sleep disorder other than insomnia
12. Previous sleepiness-related motor-vehicle accident


Based on presenting symptoms, potential participants who are not eligible for this trial will be directed to a specialist Insomnia Treatment Program to access CBTi delivered by experienced 'sleep' Psychologists, or their general practitioner.

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)
No allocation concealment will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (1:1) using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants in the waitlist control condition will be provided written material on insomnia an sleep health for the first 5-weeks of the trial (education control), and will be provided access to the dCBTi program following the 8-week follow-up.

Additional follow-up questionnaire assessments will be collected at 16-weeks, and 24-weeks post-randomisation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is based on effect sizes and variability from a previous randomised controlled trial investigating the effect of a 4-session (psychologist administered) CBTi program, versus waitlist control, on change ISI scores between baseline and 6-week follow-up (https://doi.org/10.1093/sleep/zsz178).

Linear Mixed Models will be used to investigate the between-group difference in change in ISI scores from baseline to 8-week follow-up.

An alpha level of less than 0.05 will be used, and greater than or equal to 80% power will be required. Based on a 4.5-point difference in reduction of ISI scores between the intervention and control group (standard deviation of 5), 20 participants will be required in each group to detect a statistically significant difference. To account for an estimated 50% attrition from each group (This level of attrition is common in digital interventions), we will recruit 30 participants per group (60 participants total).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2022
Actual
31/07/2022
Date of last participant enrolment
Anticipated
1/09/2022
Actual
14/03/2023
Date of last data collection
Anticipated
29/08/2023
Actual
29/08/2023
Sample size
Target
60
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309241 0
Self funded/Unfunded
Name [1] 309241 0
NA
Country [1] 309241 0
Primary sponsor type
University
Name
The Adelaide Institute for Sleep Health, Flinders University
Address
The Adelaide Institute for Sleep Health
Flinders University
Box 6, Level 2A Mark Oliphant Building
5 Laffer Drive
Bedford Park, 5042, South Australia
Country
Australia
Secondary sponsor category [1] 310208 0
None
Name [1] 310208 0
Address [1] 310208 0
Country [1] 310208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309088 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 309088 0
Ethics committee country [1] 309088 0
Australia
Date submitted for ethics approval [1] 309088 0
01/09/2021
Approval date [1] 309088 0
14/04/2022
Ethics approval number [1] 309088 0

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

Contacts
Principal investigator
Name 112930 0
Dr Alexander Sweetman
Address 112930 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
Flinders University
South Australia
Country 112930 0
Australia
Phone 112930 0
+61 8 7421 9908
Fax 112930 0
Email 112930 0
[email protected]
Contact person for public queries
Name 112931 0
Alexander Sweetman
Address 112931 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
Flinders University
South Australia
Country 112931 0
Australia
Phone 112931 0
+61 8 7421 9908
Fax 112931 0
Email 112931 0
[email protected]
Contact person for scientific queries
Name 112932 0
Alexander Sweetman
Address 112932 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
Flinders University
South Australia
Country 112932 0
Australia
Phone 112932 0
+61 8 7421 9908
Fax 112932 0
Email 112932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not requested in participant information and consent forms (ethics).


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.