Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12624001196538p
Ethics application status
Submitted, not yet approved
Date submitted
26/06/2024
Date registered
30/09/2024
Date last updated
30/09/2024
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)
Query!
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.
Query!
Secondary ID [1]
312268
0
None
Query!
Universal Trial Number (UTN)
U1111-1308-7589
Query!
Trial acronym
REST UP
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Insomnia
333984
0
Query!
Condition category
Condition code
Mental Health
330648
330648
0
0
Query!
Other mental health disorders
Query!
Neurological
330649
330649
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
328724
0
Treatment: Other
Query!
Intervention code [2]
328725
0
Behaviour
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
338400
0
Insomnia Severity Index (ISI) questionnaire.
Query!
Assessment method [1]
338400
0
Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire.
Query!
Timepoint [1]
338400
0
Between-group change in ISI scores from baseline to 10-weeks and 6-month follow-up post-randomisation.
Query!
Secondary outcome [1]
435779
0
Depressive symptoms.
Query!
Assessment method [1]
435779
0
Between-group change in self-reported depressive symptoms on the Patient Health Questionnaire (PHQ-9).
Query!
Timepoint [1]
435779
0
Between-group change in PHQ-9 scores from baseline to 10-weeks and 6-month follow-up post-randomisation.
Query!
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).
Query!
Assessment method [2]
435780
0
Self-reported use of sedative-hypnotic, and over-the-counter medicines used for insomnia in the previous month. Assessed via self-report during online questionnaire batteries.
Query!
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.
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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).
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/02/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
1/08/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
1/04/2027
Query!
Actual
Query!
Sample size
Target
405
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Funding & Sponsors
Funding source category [1]
316653
0
Government body
Query!
Name [1]
316653
0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Query!
Address [1]
316653
0
Query!
Country [1]
316653
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
318839
0
None
Query!
Name [1]
318839
0
Query!
Address [1]
318839
0
Query!
Country [1]
318839
0
Query!
Ethics approval
Ethics application status
Submitted, not yet approved
Query!
Ethics committee name [1]
315432
0
Bond University Human Research Ethics Committee
Query!
Ethics committee address [1]
315432
0
https://bond.edu.au/ethics
Query!
Ethics committee country [1]
315432
0
Australia
Query!
Date submitted for ethics approval [1]
315432
0
16/09/2024
Query!
Approval date [1]
315432
0
Query!
Ethics approval number [1]
315432
0
Query!
Summary
Brief summary
Insomnia is a prevalent and debilitating disorder in Australia. Cognitive behavioural therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia (Qaseem et al., 2016, Ann Intern Med). However, there are very few clinicians in Australia with training in CBTi. Consequently, most patients with insomnia never access CBTi (Miller et al., 2017, JCSM). This project aims to test the effectiveness of a dCBTi intervention in the Australian general practice context. Self-guided and clinician-guided 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 cluster randomised controlled implementation trial aims to investigate the effectiveness of three digital treatment options for insomnia in Australian general practice. Following recruitment of eligible patients with insomnia symptoms, general practice clinics will be cluster-randomised 1:1:1 to; 1. Digital sleep hygiene education (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 sessions with general practitioner to provide guidance and motivational support). It is hyopthesised that the groups that receive the digital CBTi program will report a greater reduction in insomnia and depressive symptoms and lower rates of medicine use for insomnia, compared to the group that receive sleep education (control). Furthermore, it is hypothesised that the group that receive clinician-guided digital CBTi will experience greater reduction of insomnia and depressive symptoms, and lower rates of medicine use for insomnia compared to the group that receive self-guided digital CBTi.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
134682
0
Prof Nicholas Zwar
Query!
Address
134682
0
Health Sciences & Medicine, Bond University, 14 University Dr, Robina QLD 4226
Query!
Country
134682
0
Australia
Query!
Phone
134682
0
+61755955499
Query!
Fax
134682
0
Query!
Email
134682
0
[email protected]
Query!
Contact person for public queries
Name
134683
0
Dr Alexander Sweetman
Query!
Address
134683
0
Adelaide Institute for Sleep Health, Mark Oliphant Building, 5 Laffer Drive, Bedford Park, Flinders University, South Australia, 5042
Query!
Country
134683
0
Australia
Query!
Phone
134683
0
+61874219908
Query!
Fax
134683
0
Query!
Email
134683
0
[email protected]
Query!
Contact person for scientific queries
Name
134684
0
Dr Alexander Sweetman
Query!
Address
134684
0
Adelaide Institute for Sleep Health, Mark Oliphant Building, 5 Laffer Drive, Bedford Park, Flinders University, South Australia, 5042
Query!
Country
134684
0
Australia
Query!
Phone
134684
0
+61874219908
Query!
Fax
134684
0
Query!
Email
134684
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Not requested in participant information and consent forms (ethics).
Query!
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.
Download to PDF