Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000311550
Ethics application status
Approved
Date submitted
13/02/2024
Date registered
22/03/2024
Date last updated
16/06/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Digital insomnia treatment in Australian pharmacy settings.
Scientific title
Effectiveness and engagement with a digital insomnia treatment program in Australian pharmacy settings: A randomised controlled trial.
Secondary ID [1] 311535 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia disorder 332889 0
Condition category
Condition code
Mental Health 329604 329604 0 0
Other mental health disorders
Neurological 329605 329605 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 pharmacists access to an online referral pathway, to refer their patients to an online Cognitive Behavioural Therapy for Insomnia (CBTi) program.

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

Patients referred to the trial by pharmacists 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, pharmacists and 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; 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 pharmacy settings.

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, Relaxation therapy, Cognitive restructuring, 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] 327992 0
Treatment: Other
Intervention code [2] 327993 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 packets derived from Sleep Health Foundation fact-sheets (https://www.sleephealthfoundation.org.au/all-sleep-factsheets-a-z) 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] 337392 0
Rate of pharmacist recruitment.
Timepoint [1] 337392 0
Study-level outcome:
Assessed at conclusion of the study.
Primary outcome [2] 337393 0
Patient-level outcome:
Between-group difference in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire.
Timepoint [2] 337393 0
8-week follow-up.
Secondary outcome [1] 431664 0
Pharmacist engagement outcome.
Timepoint [1] 431664 0
Study-level outcome:
Assessed at conclusion of the study.
Secondary outcome [2] 431665 0
Patient-level outcome:
Between-group difference in self-reported insomnia severity on the Patient Health Questionnaire (PHQ-9) questionnaire.
Timepoint [2] 431665 0
8-week follow-up.
Secondary outcome [3] 431666 0
Patient-level outcome:
Between-group difference in self-reported fatigue severity on the Flinders Fatigue Scale.
Timepoint [3] 431666 0
8-week follow-up.
Secondary outcome [4] 433076 0
Patient-level outcome:
Insomnia Severity Index (ISI) score in the CBTi group only.
Timepoint [4] 433076 0
16-weeks and 24-weeks follow-up
Secondary outcome [5] 433077 0
Patient-level outcome:
Depression symptoms on the Patient Health Questionnaire (PHQ-9) score in the CBTi group only.
Timepoint [5] 433077 0
16-weeks and 24-weeks follow-up
Secondary outcome [6] 433078 0
Patient-level outcome:
Flinders Fatigue Scale (FFS) score in the CBTi group only.
Timepoint [6] 433078 0
16-weeks and 24-weeks follow-up

Eligibility
Key inclusion criteria
Pharmacist inclusion criteria:
1. Currently practicing as a pharmacist in Australia.

Patient inclusion criteria:
1. Aged at least 18
2. Referred by participating pharmacist.
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?
Yes
Key exclusion criteria
1. No excessive daytime sleepiness (Epworth Sleepiness Scale score score of greater than or equal to 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 pharmacists and the patients that they refer to this online insomnia treatment program study.

Pharmacist-level analyses:
Primary endpoints will include rates of pharmacist recruitment and engagement with the pathway (pharmacist completion of consent form, and rates of patient referrals over time), accessed via study records at study conclusion.

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 insomnia, depression, and fatigue symptoms at 8-week (post-treatment) follow-up, and improvement in symptoms b 24-week follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315831 0
Self funded/Unfunded
Name [1] 315831 0
NA
Country [1] 315831 0
Australia
Primary sponsor type
University
Name
The Adelaide Institute for Sleep Health, Flinders University
Address
Country
Australia
Secondary sponsor category [1] 317961 0
None
Name [1] 317961 0
Address [1] 317961 0
Country [1] 317961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314688 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 314688 0
https://www.sahealth.sa.gov.au/wps/wcm/connect/Public%2BContent/SA%2BHealth%2BInternet/About%2Bus/Our%2BLocal%2BHealth%2BNetworks/Southern%2BAdelaide%2BLocal%2BHealth%2BNetwork/Research/For%2BResearchers/Southern%2BAdelaide%2BClinical%2BHuman%2BResearch%2BEthics%2BCommittee
Ethics committee country [1] 314688 0
Australia
Date submitted for ethics approval [1] 314688 0
09/02/2024
Approval date [1] 314688 0
26/03/2024
Ethics approval number [1] 314688 0
28.24 Southern Adelaide Clinical Human Research Ethics Committee

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 pharmacy settings. Patients that are referred, eligible and consent to participate will be randomised 1:1 to a digital brief cognitive behavioural therapy for insomnia program, versus waitlist education control.

It is hypothesised that the group who receive the brief CBTi program will report a reduced severity of insomnia, depression and fatigue symptoms, compared to the group that receive education (waitlist control).

• It is hypothesised that the digital CBTi program will be adopted by at least two new pharmacists in Australia per month of the study.
• It is hypothesised that at least 50% of pharmacists will refer 3 or more patients to the digital CBTi referral pathway.
• It is hypothesised that the intervention group will report a reduced severity of insomnia, depression, and fatigue symptoms from 8-week follow-up, compared to the education control group.
• It is hypothesised that insomnia, depression, and fatigue symptom improvements will be sustained by 16-week and 24-week follow-up in the CBTi group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132398 0
Dr Alexander Sweetman
Address 132398 0
Adelaide Institute for Sleep Health, Mark Oliphant Building, Level 2A, 5 Laffer Drive, Bedford Park, 5042 Flinders University South Australia
Country 132398 0
Australia
Phone 132398 0
+61 8 7421 9908
Fax 132398 0
Email 132398 0
alexander.sweetman@flinders.edu.au
Contact person for public queries
Name 132399 0
Alexander Sweetman
Address 132399 0
Adelaide Institute for Sleep Health, Mark Oliphant Building, Level 2A, 5 Laffer Drive, Bedford Park, 5042 Flinders University South Australia
Country 132399 0
Australia
Phone 132399 0
+61 8 7421 9908
Fax 132399 0
Email 132399 0
alexander.sweetman@flinders.edu.au
Contact person for scientific queries
Name 132400 0
Alexander Sweetman
Address 132400 0
Adelaide Institute for Sleep Health, Mark Oliphant Building, Level 2A, 5 Laffer Drive, Bedford Park, 5042 Flinders University South Australia
Country 132400 0
Australia
Phone 132400 0
+61 8 7421 9908
Fax 132400 0
Email 132400 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.