Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001539123
Ethics application status
Approved
Date submitted
27/08/2019
Date registered
7/11/2019
Date last updated
22/01/2021
Date data sharing statement initially provided
7/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Insomnia Treatment in Australian General Practice
Scientific title
Online Cognitive and Behavioural Therapy for Insomnia in Australian General Practice: An Implementation Trial
Secondary ID [1] 298296 0
Nil known
Universal Trial Number (UTN)
U1111-1233-8136
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 312922 0
Condition category
Condition code
Public Health 311415 311415 0 0
Health service research
Neurological 312702 312702 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This implementation trial will investigate the feasibility and effectiveness of providing Australian General Practitioners, and general practice patients access to online cognitive and behavioural therapy for insomnia (CBTi), and Royal Australian College of General Practitioner (RACGP) guideline recommendations on 'insomnia' management and 'sleeping pill withdrawal'.

We will use existing General Practitioner software to identify three groups of patients, based on recent history of medications commonly prescribed for insomnia (including; Temazepam, Oxazepam, Nitrazepam, Zolpidem, Zopiclone and Melatonin). We will divide patients into those with;
1. New Insomnia - No history of sleeping pills prescribed in the past 12 months,
2. Single Sleeping Pill Prescription - One sleeping pill prescription in the past 12 months
3. Repeat Sleeping Pill Prescriptions - Two or more sleeping pill prescriptions in the past 12 months

Online CBTi will be made available to all three groups of patients. Sleepio (www.sleepio.com, Big Health, UK) is a well-established online CBTi program which includes 6-weekly self-administered sessions. Sleepio includes CBTi components; bedtime restriction therapy, stimulus control therapy, sleep hygiene information, relaxation therapy, and cognitive restructuring techniques. Patients may complete daily sleep diaries (3 min) in addition to weekly CBTi sessions (20-30 minutes each). Patients will receive reminder and summary emails to promote adherence throughout the program, however no additional support will be offered to encourage adherence.

Via GP software, treating GPs will be sent notifications containing patient-tailored RACGP insomnia management guidelines and sleeping pill withdrawal information. These GP notifications will differ based on the above patient groups;
1. New Insomnia - GPs will receive a notification containing RACGP guidelines and a referral link to online CBTi,
2. Single Sleeping Pill Prescription - GPs will receive a notification containing RACGP guidelines, printable sleeping pill withdrawal fact sheets and tapering schedules, and a referral link to online CBTi, and
3. Repeat Sleeping Pill Prescriptions - GPs will receive a notification containing RACGP guidelines, printable sleeping pill withdrawal fact sheets and tapering schedules, and a referral link to online CBTi.
Intervention code [1] 314530 0
Treatment: Other
Comparator / control treatment
Patients identified with "New Insomnia" (no history of sleeping pills prescribed in the past 12 months).
Control group
Active

Outcomes
Primary outcome [1] 320136 0
Change in number of sleeping pill prescriptions (assessed via data linkage to MBS/PBS data, for prescriptions of Benzodiazepines, 'z-drugs', and Melatonin) in patients recruited to the trial.
Timepoint [1] 320136 0
Change in number of sleeping pill prescriptions from the 12-month period preceding trial recruitment to the 12-month period following recruitment to the trial.
Primary outcome [2] 321343 0
Change in the number of self-reported sleeping pills consumed in patients recruited to the trial.
Timepoint [2] 321343 0
Change in the self-reported number of sleeping pills consumed in the last two weeks at pre-treatment, 8-weeks, 6-months, and 12-months follow-up.
Primary outcome [3] 321344 0
Change in self-reported Insomnia Severity Index scores in patients recruited to the trial
Timepoint [3] 321344 0
Change in Insomnia Severity Index scores from pre-treatment, to 8-week, 6-month, and 12-month follow-up.
Secondary outcome [1] 370667 0
Change in self-reported Daytime Feelings and Functioning Scale scores in patients recruited to the trial.
Timepoint [1] 370667 0
Change in Daytime Feelings and Functioning Scale scores from pre-treatment, to 8-week, 6-month, and 12-month follow-up.
Secondary outcome [2] 374309 0
Change in self-reported EQ-5D-5L (Quality of Life) scores in patients recruited to the trial.
Timepoint [2] 374309 0
Change in EQ-5D-5L (Quality of Life) scores from pre-treatment, to 8-week, 6-month, and 12-month follow-up.
Secondary outcome [3] 374310 0
Perceived barriers and facilitators of trial from the perspective of participating General Practitioners, measured via semi-structured qualitative interviews (Composite Outcome).
Timepoint [3] 374310 0
Semi-structured qualitative interviews will be undertaken with consenting General Practitioners, after they have referred at least three patients to the trial..
Secondary outcome [4] 374704 0
Health Economics Analysis (Composite Outcome), including changes in MBS/PBS items, patient self-reported insomnia severity (Insomnia Severity Index) and quality of life (EQ-5D-5L) outcomes.
Timepoint [4] 374704 0
Changes in MBS/PBS items, patient self-reported insomnia severity and quality of life will be assessed at pre-treatment, 8-weeks, 6-months, and 12-months.

Eligibility
Key inclusion criteria
General Practitioner Inclusion Criteria;
1. Currently using the Doctors Control Panel software

Patient Inclusion Criteria
1. Age > 18 years.
2. Reliable access to computer, tablet or smartphone, with internet access
3. Basic English language comprehension as required for Sleepio.

Group 1 "New Insomnia" - No GP prescriptions of Temazepam, Oxazepam, Nitrazepam, Zolpidem, Zopiclone, or Melatonin in the past 12 months,

Group 2 "Single Sleeping Pill Prescription" - One GP prescription of Temazepam, Oxazepam, Nitrazepam, Zolpidem, Zopiclone, or Melatonin in the past 12 months,

Group 3 "Repeat Sleeping Pill Prescriptions" - Any combination of two or more GP prescriptions of Temazepam, Oxazepam, Nitrazepam, Zolpidem, Zopiclone, or Melatonin in the past 12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient Exclusion Criteria (assessed by treating GPs, according to RACGP/Sleepio recommendations);
1. Drug or alcohol problems
2. Terminal illness
3. Acute crisis
4. Risk of suicide
5. Severe mental illness
6. Organic brain disease
7. Epilepsy requiring benzodiazepine as part of anticonvulsant therapy
8. Benzodiazepine prescriptions for muscle spasms
9. Women who are currently pregnant

Patient Exclusion Criteria (Assessed via online self-reported screening questionnaire):
1. Any previous diagnosis of Obstructive Sleep Apnea, Restless Legs Syndrome, or REM Behaviour Disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
We will use existing General Practitioner software to screen patients for a recent history of sleeping pill prescriptions. Based on these data, patients will be divided into three groups;
1. New Insomnia - No history of sleeping pills prescribed in the past 12 months,
2. Single Sleeping Pill Prescription - One sleeping pill prescribed in the past 12 months
3. Repeat Sleeping Pill Prescriptions - Two or more sleeping pills prescribed in the past 12 months

Via GP software, treating GPs will be sent notifications containing patient-tailored RACGP insomnia management guidelines and sleeping pill withdrawal information. These GP notifications will differ based on the above patient groups;
1. New Insomnia - GPs will receive a notification containing RACGP guidelines and a referral link to online CBTi,
2. Single Sleeping Pill - GPs will receive a notification containing RACGP guidelines, printable sleeping pill withdrawal fact sheets and tapering schedules, and a referral link to online CBTi, and
3. Repeat Sleeping Pill - GPs will receive a notification containing RACGP guidelines, printable sleeping pill withdrawal fact sheets and tapering schedules, and a referral link to online CBTi.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis:
Sample size requirements have been modelled to meet three criteria;
1. Required sample size to inform Australian healthcare policy (as recommended by External CRE Policy and Practice Committee),
2. Required sample size to detect between-group difference in changes in self-reported insomnia improvements from baseline to 12-months, and
3. Required sample size to detect change in rate of sleeping pill cessation, and average weekly sleeping pill use following treatment.

All analyses assume a Type 1 error rate of .05, and sample calculations provide 80% power.

Primary analyses will include between-group differences in improvements in insomnia severity from baseline to 12-month follow-up (Linear Mixed Model analyses), and differences in rate of GP sleeping pill cessation from the 12-month period before trial-referral, to the 12-month period following trial registration (Chi-square and Linear Mixed Model analyses).

In addition to the Primary and Secondary Outcomes Described in Step 4, we aim to examine differences in changes in insomnia severity and change in sleeping pill use from pre-treatment to 12-month follow-up, between patients with "New Insomnia", "Single Sleeping Pill" history, and "Repeat Sleeping Pill" history..

125 participants per condition will provide 80% power to detect a 3-point between-group difference in improvements in insomnia severity (Insomnia Severity Index) (1) from pre-treatment to 12-months follow-up, assuming a change-score standard deviation of 6.5 (based on our prior CBTi research (2)), and an estimated 35% attrition rate from online CBTi (based on previous research including online CBTi interventions).

Research examining the effect of online CBTi on sleeping pill prescriptions has reported that 18-50% of patients using sleeping pills at baseline cease use following CBTi. Assuming that 67% of patients across the three groups are using sleeping pills at baseline, a sample of 276 (92 per group) will provide 83% power to detect a conservative 18% rate of sleeping pill cessation following treatment. To account for a 35% attrition rate from online CBTi (as determined from previous research of online CBTi), we will recruit 125 participants to each group (375 participants total).

Our external Policy and Practice Committee have indicated that a sample of 125 per group (375 participants total) will be required to inform Australian healthcare policy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2020
Actual
25/09/2020
Date of last participant enrolment
Anticipated
1/03/2021
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
375
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 302839 0
Government body
Name [1] 302839 0
National Health and Medical Research Council
Country [1] 302839 0
Australia
Primary sponsor type
University
Name
The Adelaide Institute for Sleep Health, Flinders University
Address
Adelaide Institute for Sleep Health
Flinders University of South Australia
5 Laffer Drive, Mark Oliphant Building, Level 2A
Bedford Park, 5042, South Australia
Country
Australia
Secondary sponsor category [1] 303768 0
None
Name [1] 303768 0
Address [1] 303768 0
Country [1] 303768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303417 0
Royal Australian College of General Practitioners (RACGP) Ethics Committee (NREEC)
Ethics committee address [1] 303417 0
RACGP Foundation Research Officer and NREEC Secretariat
The Royal Australian College of General Practitioners
100 Wellington Parade, East Melbourne, VIC 3002
Ethics committee country [1] 303417 0
Australia
Date submitted for ethics approval [1] 303417 0
11/11/2019
Approval date [1] 303417 0
23/06/2020
Ethics approval number [1] 303417 0
RACGP NREEC: 19-013

Summary
Brief summary
Insomnia is a common disorder managed in Australian general practice. Insomnia can be effectively treated with online cognitive and behavioural therapy for insomnia (CBTi), which leads to long-lasting insomnia improvements. We aim to provide Australian GPs with access to an online CBTi program (Sleepio) to treat insomnia and reduce dependence on sleeping pills over time.

It is hypothesised that patients referred to this trial of Sleepio will experience improved insomnia symptoms, and reduced sleeping pill use over time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93606 0
Dr Alexander Sweetman
Address 93606 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
South Australia
Country 93606 0
Australia
Phone 93606 0
+61 8 7421 9908
Fax 93606 0
Email 93606 0
alexander.sweetman@flinders.edu.au
Contact person for public queries
Name 93607 0
Dr Alexander Sweetman
Address 93607 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
South Australia
Country 93607 0
Australia
Phone 93607 0
+61 8 7421 9908
Fax 93607 0
Email 93607 0
alexander.sweetman@flinders.edu.au
Contact person for scientific queries
Name 93608 0
Dr Alexander Sweetman
Address 93608 0
Adelaide Institute for Sleep Health,
Mark Oliphant Building, Level 2A
5 Laffer Drive, Bedford Park, 5042
South Australia
Country 93608 0
Australia
Phone 93608 0
+61 8 7421 9908
Fax 93608 0
Email 93608 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
Participant consent for only chief/associate-investigator use of study data.


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
SourceTitleYear of PublicationDOI
EmbaseImplementation of a digital cognitive behavioral therapy for insomnia pathway in primary care.2021https://dx.doi.org/10.1016/j.cct.2021.106484
N.B. These documents automatically identified may not have been verified by the study sponsor.