Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001463763
Ethics application status
Approved
Date submitted
4/11/2022
Date registered
17/11/2022
Date last updated
7/02/2023
Date data sharing statement initially provided
17/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Digital insomnia treatment in Australian primary care
Scientific title
Feasibility and effectiveness of a digital insomnia treatment in Australian primary care
Secondary ID [1] 308347 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia disorder 328139 0
Condition category
Condition code
Mental Health 325193 325193 0 0
Other mental health disorders
Neurological 325194 325194 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised waitlist-controlled implementation trial will investigate the feasibility and effectiveness of providing Australian general practitioners access to an online referral pathway, to refer their patients to an online Cognitive Behavioural Therapy for Insomnia (CBTi) program.

General practitioners, and a selection of eligible patients they refer to the study will be recruited.

Patients referred to the trial by general practitioners will undergo online screening and consent. Eligible patients will complete a baseline questionnaire battery before being randomised 1:1 to a 5-session online CBTi program, or waitlist education-control. Patients will complete outcome questionnaires at 8, 16, and 24 weeks. The waitlist control group will be provided access to the online CBTi program after the 8-week follow-up.

With consent from patients, general practitioners will be provided a follow-up report of patient progress at 8, 16, and 24 week follow-up. GP follow-up reports will be generated by the study team and will include participant-level information on; the number of sessions completed, change in insomnia symptoms before and after treatment, sleeping pill use, and date of next follow-up report.

Information about the online CBTi program appears below.

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 general practice 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 an interactive online 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. Patients 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] 324796 0
Treatment: Other
Intervention code [2] 324797 0
Behaviour
Comparator / control treatment
Waitlist education control for 8 weeks before commencing dCBTi.

Participants in the waitlist condition will receive weekly emails with written (pdf) 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] 333024 0
General practitioner-level outcome:
General practitioner engagement (recruitment). These data will be collected by audit of study records (rates of online GP information and consent completion).
Timepoint [1] 333024 0
Number of general practitioners recruited to the trial per month of the study.
Primary outcome [2] 333025 0
General practitioner-level outcome:
Number of patients referred to trial by participating general practitioners. These data will be collected by audit of study referral records (rate of patient referrals over time through online referral website).
Timepoint [2] 333025 0
Number of patients referred to the study by participating general practitioners per month of the study.
Primary outcome [3] 333026 0
Patient-level outcome:

Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire.
Timepoint [3] 333026 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] 415576 0
Patient-level outcome:
Between-group change in self-reported depression symptoms on the Patient Health Questionnaire (PHQ-9).
Timepoint [1] 415576 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.

Eligibility
Key inclusion criteria
General practitioner inclusion criteria:
1. Currently practicing as a general practitioner in Australia.

Patient inclusion criteria:
1. Aged at least 18
2. Referred by participating GP.
3. Reliable access to computer, tablet or smartphone, with internet access.
4. Basic English language comprehension as required for dCBTi program participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No excessive daytime sleepiness (Epworth Sleepiness Scale score =16).
2. None of the following psychiatric conditions; Bi-polar disorder, schizophrenia.
3. No risk of suicide (PHQ-9; item 9 score of greater than or equal to 1).
4. No Epilepsy.
5. Not currently pregnant.
6. No commercial drivers or people who operate heavy machinery for work.
7. No people with a cognitive impairment.
8. No shift-workers.
9. Previous sleepiness-related motor vehicle accident.

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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This implementation trial will recruit general practitioners and the patients that they refer to this online insomnia treatment program study.

General practitioner-level analyses:
Primary endpoints will include rates of general practitioner engagement with the pathway (general practitioner completion of consent form, and rates of patient referrals over time).

Patient-level analyses:
Referred patients will be recruited to a parallel-arm randomised waitlist-controlled trial. Intention to treat, mixed models will be used to investigate between-group differences in changes in insomnia symptoms and depression symptoms from baseline to 8-week (post-treatment) follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2023
Actual
12/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312591 0
Self funded/Unfunded
Name [1] 312591 0
NA
Country [1] 312591 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] 314203 0
None
Name [1] 314203 0
Address [1] 314203 0
Country [1] 314203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311917 0
Southern Adelaide Human Research Ethics Committee
Ethics committee address [1] 311917 0
Flinders Medical Centre, Level 6, Ward 6C, Room 6A219
Flinders Drive, Bedford Park, SA 5042
Southern Adelaide Local Health Network
Ethics committee country [1] 311917 0
Australia
Date submitted for ethics approval [1] 311917 0
30/10/2022
Approval date [1] 311917 0
11/01/2023
Ethics approval number [1] 311917 0
2022/HRE00272

Summary
Brief summary
Insomnia is a prevalent and debilitating disorder in Australia. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTi). However, there are very few clinicians in Australia with training in CBTi. Consequently, most patients with insomnia never access CBTi.

Digital CBTi programs are an effective and potentially scalable intervention to manage insomnia. There are very few evidence-based digital CBTi programs available in Australia, and currently no publicly-available digital CBTi programs that provide personalised weekly behavioural therapy recommendations.

This randomised controlled implementation trial aims to investigate the feasibility and effectiveness of a digital CBTi referral pathway in Australian general practice. Patients that are referred, eligible and consent to participate will be randomised 1:1 to a digital brief cognitive behavioural therpay for insomnia program, versus waitlist education control.

It is hyopthesised that the group who receive the brief CBTi program will report a greater reduction in insomnia symptoms, compared to the group that receive education (waitlist control).

• It is hypothesised that the digital CBTi program will be adopted by general practitioners throughout each state and territory of Australia.
• It is hypothesised that there will be an increasing number of patient referrals to the study during each month of the study.
• It is hypothesised that the intervention group will report a greater improvement in insomnia, and depression symptoms from baseline to 8-week follow-up, compared to the education control group.
• It is hypothesised that insomnia and depression symptom improvements will be sustained by 16-week and 24-week follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122830 0
Dr Alexander Sweetman
Address 122830 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
Flinders University
South Australia
Country 122830 0
Australia
Phone 122830 0
+61 8 7421 9908
Fax 122830 0
Email 122830 0
alexander.sweetman@flinders.edu.au
Contact person for public queries
Name 122831 0
Dr Alexander Sweetman
Address 122831 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
Flinders University
South Australia
Country 122831 0
Australia
Phone 122831 0
+61 8 7421 9908
Fax 122831 0
Email 122831 0
alexander.sweetman@flinders.edu.au
Contact person for scientific queries
Name 122832 0
Dr Alexander Sweetman
Address 122832 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
Flinders University
South Australia
Country 122832 0
Australia
Phone 122832 0
+61 8 7421 9908
Fax 122832 0
Email 122832 0
alexander.sweetman@flinders.edu.au

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.