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Trial registered on ANZCTR


Registration number
ACTRN12624001196538
Ethics application status
Approved
Date submitted
26/06/2024
Date registered
30/09/2024
Date last updated
8/12/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Research and Evaluation Study of digital Treatment of insomnia in Underserved Populations (REST UP)
Scientific title
The effectiveness of self-guided versus clinician-guided digital cognitive behavioural therapy for insomnia, versus digital sleep health education, on insomnia symptom severity in primary care priority populations: A three-arm randomised controlled effectiveness-implementation trial.
Secondary ID [1] 312268 0
None
Universal Trial Number (UTN)
U1111-1308-7589
Trial acronym
REST UP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 333984 0
Condition category
Condition code
Mental Health 330648 330648 0 0
Other mental health disorders
Neurological 330649 330649 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This three-arm cluster randomised controlled implementation trial will investigate the effectiveness of three digital treatment approaches for insomnia in Australian general practice.

27 general practice clinics (predominantly in rural and regional locations) will be recruited. General practitioners in participating clinics will be invited to identify and recruit a total of 405 patients with insomnia symptoms to the trial (15 patients per clinic). Patients will be invited to complete online consent and screening forms, and a baseline questionnaire battery. Eligibility will be confirmed by research personnel prior to patient recruitment to the trial.

Following recruitment of 15 patients with insomnia, general practice clinics (and patients belonging to that clinic) will be randomly allocated to one of three groups. To reduce delays between patient recruitment and randomisation, clinics will be randomised in blocks of 6 as they complete practice recruitment;

Study groups:
1. Digital sleep health education (augmented treatment as usual control)
2. Self-guided digital cognitive behavioural therapy for insomnia program
3. Clinician-guided digital cognitive behavioural therapy for insomnia program (digital program plus three consultations with the general practitioner).

Patients will complete a self-report online outcome questionnaire battery at baseline (before clinic randomisation), 10-weeks, and 6-months post-randomisation.

Information about the online CBTi program appears below.

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: CBTi is the recommended 'first line' treatment for insomnia (e.g. Qaseem et al., 2016, Ann Intern Med, DOI: 10.7326/M15-2175). However, the majority of people with insomnia in Australia do not access CBTi (DOI: 10.5664/jcsm.6616). Digital CBTi programs may offer an effective and feasible solution to improve access to CBTi. The digital CBTi program "Bedtime Window" will be used (DOI: 10.3389/frsle.2024.1355468).

Bedtime Window is a 5-session interactive digital CBTi program. Each session will be administered online (computer or mobile phone). Each session will contain videos, text, and images. Patients are asked to enter text-based, numerical (e.g. minutes of sleep duration) and multiple-choice data throughout the program. Participants receive tailored therapy recommendations during each weekly session (DOI: 10.3389/frsle.2024.1355468). 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 insomnia and sleep/wake symptoms throughout the program.

Patients in the third study group will additionally receive three consultations with their general practitioner during the 5-week period that they are completing the program. Three consultations with a general practitioner are expected to last for approximately 10-15 minutes each. These consultations are expected to be delivered alongside completion of sessions 1, 2, and 4 of the digital program (or as close as possible to completion of these sessions). During consultations, general practitioners will provide onboarding and tailoerd sleep assessment support, reinforce concepts and provide motivational support to encourage adherence to recommendations of the digital program, identify and overcome barriers to completion of the digital program, and support any changes to sedative-hypnotic use. Adherence to these consultations will be monitored through clinical electronic medical records.

Primary therapeutic components: Information about sleep, Bedtime restriction therapy, Stimulus control therapy, Relaxation therapy, Cognitive re-focusing, and Relapse prevention.

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] 328724 0
Treatment: Other
Intervention code [2] 328725 0
Behaviour
Comparator / control treatment
Participants in the control group will receive weekly emails with links to text-based information packets about insomnia and sleep health for the first 5 weeks of the trial, produced by the Sleep Health Foundation.

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. Participant access to each weekly information packet will be monitored through an online system as an indicator of adherence to control information packets.
Control group
Active

Outcomes
Primary outcome [1] 338400 0
Insomnia Severity Index (ISI) questionnaire.
Timepoint [1] 338400 0
Between-group change in ISI scores from baseline to 10-weeks and 6-month follow-up post-randomisation.
Secondary outcome [1] 435779 0
Depressive symptoms.
Timepoint [1] 435779 0
Between-group change in PHQ-9 scores from baseline to 10-weeks and 6-month follow-up post-randomisation.
Secondary outcome [2] 435780 0
Use of medicines for insomnia (Assessed as a composite secondary outcome including prescription and over-the-counter medicines for insomnia).
Timepoint [2] 435780 0
Between-group difference in self-reported use of medicines for insomnia (binary outcome) at 10-weeks and 6-month follow-up post-randomisation.

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 years
2. Referred by a participating general practitioner, according to GP-identified insomnia symptoms, general practice electronic medical record notes identifying diagnosis or clinical problem of insomnia lasting at least 3 months, and/or prescription of sedatives or hypnotics for insomnia symptoms
3. Reliable access to a computer, tablet, or smartphone with internet access.
4. Basic English language comprehension as required for CBTi program participation.
5. Active patients of the participating general practice clinic (have attended at least 3 times in the last two years).
6. Insomnia symptoms according to an Insomnia Severity Index score of at least 15, that have persisted for at least 3 months (indicative of chronic insomnia)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Doctor-diagnosed sleep disorders other than insomnia (e.g. sleep apnoea, narcolepsy).
2. Excessive daytime sleepiness (Epworth Sleepiness Scale Score >15).
3. Current psychological treatment for insomnia,
4. Shift work within the past 3 months,
5. Significant cognitive impairment, terminal illness, severe psychiatric condition (e.g., bipolar disorder or schizophrenia disorder), or epilepsy.
6. Currently pregnant.
7. Previous sleepiness-related motor-vehicle accident.
8. Driver, pilot, or operates heavy machinery for work.
9. No self-reported risk of self-harm (identified by a score of greater than or equal to 1 on the PHQ-9, item 9).

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)
All participants will be recruited to the trial prior to block-randomisation of general practice clinics.
Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of practices will be conducted by biostatistician. To reduce the delay between trial recruitment and access to intervention practices will be randomised (in blocks of 6) as they complete patient recruitment. Randomisation will be stratified by practice size (smaller 1-3 GPs, versus larger 4+ GPs).
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2026
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
405
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316653 0
Government body
Name [1] 316653 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 316653 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Address
Country
Australia
Secondary sponsor category [1] 318839 0
None
Name [1] 318839 0
Address [1] 318839 0
Country [1] 318839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315432 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 315432 0
Ethics committee country [1] 315432 0
Australia
Date submitted for ethics approval [1] 315432 0
16/09/2024
Approval date [1] 315432 0
18/11/2024
Ethics approval number [1] 315432 0
KL02337

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

Contacts
Principal investigator
Name 134682 0
Prof Nicholas Zwar
Address 134682 0
Health Sciences & Medicine, Bond University, 14 University Dr, Robina QLD 4226
Country 134682 0
Australia
Phone 134682 0
+61755955499
Fax 134682 0
Email 134682 0
nzwar@bond.edu.au
Contact person for public queries
Name 134683 0
Dr Alexander Sweetman
Address 134683 0
Adelaide Institute for Sleep Health, Mark Oliphant Building, 5 Laffer Drive, Bedford Park, Flinders University, South Australia, 5042
Country 134683 0
Australia
Phone 134683 0
+61874219908
Fax 134683 0
Email 134683 0
alexander.sweetman@flinders.edu.au
Contact person for scientific queries
Name 134684 0
Dr Alexander Sweetman
Address 134684 0
Adelaide Institute for Sleep Health, Mark Oliphant Building, 5 Laffer Drive, Bedford Park, Flinders University, South Australia, 5042
Country 134684 0
Australia
Phone 134684 0
+61874219908
Fax 134684 0
Email 134684 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.