Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000567729
Ethics application status
Approved
Date submitted
30/03/2022
Date registered
13/04/2022
Date last updated
11/01/2024
Date data sharing statement initially provided
13/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
WiserAD: The effect of a structured online intervention on antidepressant deprescribing in primary care.
Scientific title
WiserAD: The effect of a structured online intervention on antidepressant deprescribing in Australian adult primary care patients.
Secondary ID [1] 306834 0
Nil
Universal Trial Number (UTN)
Trial acronym
The WiserAD Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 325628 0
Inappropriate medicine 325629 0
Condition category
Condition code
Mental Health 322984 322984 0 0
Depression
Public Health 323231 323231 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive a brief <10 minute check-in phone call from the study team one week after randomisation to make sure that they have access to the intervention or attention control.

Participants will be provided with a link and personal login code for the study web portal which has been purposely built for the trial. Participants will receive the code via automated email and will be encouraged to complete the initial components of the intervention (Assess and Advise) which seek to determine participants’ current support and management strategies and help them to understand their specific antidepressants (ADs) (approx 10 minutes). They will then complete the third component which contains three sub-sections to assist in creating a personal plan to help them cease their ADs: i) Prepare – management strategies for withdrawal symptoms and opportunities to discuss the plan with their GP or trusted mental health worker; ii) Schedule - Selecting a start time to begin tapering; iii) Share – Print out of the personalised action plan to keep and share with supportive family and/or friends (approx 5 minutes total to completed). At this point, participants will also be asked to share their tapering schedule with their GP for modification if necessary. Participants will asked to complete their appointment with their GP within two weeks. Once the tapering schedule has been approved, participants will log back into the web portal and will be required to complete a daily check-in through the portal which will check current symptoms and highlight any negative changes in emotional wellbeing (approx 10 minutes), they will also receive texts reminders to complete these tasks. Apart from the reminder texts and email communications, all information will be provided to participants via the WiserAD web portal.

Participants will have access to the WiserAD online support tool for the duration of the study (minimum of 3-months post randomisation and until last data collected from the last participant, therefore up to 18-months), however they will be encouraged to begin tapering their ADs within two weeks of receiving approval of their tapering schedule. Use of the WiserAD online support tool will be monitored using purpose built analytics within the WiserAD web portal (unblinded study team access only).
Intervention code [1] 323132 0
Treatment: Other
Intervention code [2] 323334 0
Behaviour
Comparator / control treatment
Participants allocated to the treatment as usual group (ie. participants will continue to receive care from their GP as part of normal practice) will receive usual care plus attention control which comprises a link to the AD factsheet within the beyondblue website. This provides education material relevant to the participants’ enrolment in the study but they will not be advised to cease or continue with their medication. GPs will not be advised of the participants allocated to this treatment arm.
Control group
Active

Outcomes
Primary outcome [1] 330753 0
Proportion of patients successfully ceasing ADs at 6 months where successful cessation is defined as a composite of no AD use (as measured by the Resource Use Questionnaire (RUQ)) and the absence of clinically significant depressive symptoms (as measured by the Patient Health Questionnaire-9 (PHQ-9))
Timepoint [1] 330753 0
3-, 6-, 12-, 18-months post completion of baseline. Primary outcome is at 6-months post completion of baseline.
Secondary outcome [1] 407433 0
Depressive symptom severity (PHQ-9)
Timepoint [1] 407433 0
3-, 6-, 12-, 18-months post completion of baseline.
Secondary outcome [2] 407434 0
Anxiety symptoms (GAD-7)
Timepoint [2] 407434 0
Baseline, 3-, 6-, 12-, 18-months post completion of baseline.
Secondary outcome [3] 407435 0
Patient Activation Measure (PAM)
Timepoint [3] 407435 0
Baseline, 3-, 6-months post completion of baseline.
Secondary outcome [4] 407436 0
Quality of Life (AQoL-4D)
Timepoint [4] 407436 0
Baseline, 3-, 6-, 12-, 18-months post completion of baseline.
Secondary outcome [5] 407437 0
Resource Use Questionnaire (RUQ)
Timepoint [5] 407437 0
Baseline, 3-, 6-, 12-, 18-months post completion of baseline.
Secondary outcome [6] 407444 0
Signs and Symptoms Checklist (study specific questionnaire asking for text response input from participants regarding any withdrawal symptoms they may have had or are currently experiencing). Participant can input up to 3 signs and symptoms.
Timepoint [6] 407444 0
3-, 6-months post completion of baseline.
Secondary outcome [7] 407533 0
Beliefs About Medication Questionnaire (BMQ)
Timepoint [7] 407533 0
Baseline, 3-months post completion of baseline.
Secondary outcome [8] 407534 0
User Engagement Scale-Short Form (UES-SF)
Timepoint [8] 407534 0
3- and 6-months post completion of baseline.
Secondary outcome [9] 407535 0
Accountability Measurement Tool (AMT)
Timepoint [9] 407535 0
3- and 6-months post completion of baseline.
Secondary outcome [10] 407536 0
Pharmaceutical Benefit Scheme (PBS) data (pharmaceutical use)
Timepoint [10] 407536 0
Collected at completion of the study (for the whole duration of participation in the study - 18 months).
Secondary outcome [11] 408506 0
Medical Benefit Scheme (MBS) (health service utilisation)
Timepoint [11] 408506 0
Collected at completion of the study (for the whole duration of participation in the study - 18 months.).

Eligibility
Key inclusion criteria
18-75 years
Stable on AD for >=12m: (no depressive episodes)
No history of recurrent depression
Sufficient English language proficiency to provide informed consent
No or mild depressive symptoms as measured on the Personal Health Questionnaire (PHQ9)
Low risk of Suicide or Self-harm
Agree to consider reviewing their AD use
Agree to be randomized into the study
Willing to provide informed consent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those currently experiencing a major life event in the next 3 months
Currently using ADs for any other health condition (other than depression)
Currently using non-SSRI or SNRI ADs, antipsychotics, or other mood stabiliser medication
Have no daily access to the internet

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)
The treatment to which a participant is assigned will be determined by a computer generated pseudo-random code using random permuted blocks of varying size, created by the web developers and held on a secure server.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated pseudo-random code using random permuted blocks of varying size, created by the web developers and held on a secure server. Participants will be allocated with equal probability to each treatment arm and stratified by site (GP practice).
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
Descriptive statistics and marginal logistic regression using generalised estimating equations with robust standard errors to adjust for repeated outcome measures on individuals to compare binary outcomes between the two study arms at each time-point. We will use linear mixed-effects models, with random intercepts for individuals, to estimate the difference in means between the study arms at each measurement time point for continuous outcomes. Statistical analyses will be performed using STATA v15 or above.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/04/2022
Actual
25/04/2022
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
7/08/2025
Actual
Sample size
Target
312
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 310985 0
Government body
Name [1] 310985 0
National Health and Medical Research Council
Country [1] 310985 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 312331 0
None
Name [1] 312331 0
Address [1] 312331 0
Country [1] 312331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310540 0
University of Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 310540 0
Ethics committee country [1] 310540 0
Australia
Date submitted for ethics approval [1] 310540 0
25/05/2021
Approval date [1] 310540 0
12/08/2021
Ethics approval number [1] 310540 0
20558

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

Contacts
Principal investigator
Name 118014 0
Prof Jane Gunn
Address 118014 0
University of Melbourne
Faculty of Medicine Dentistry & Health Sciences
Level 2, Alan Gilbert Building
161 Barry St, Carlton VIC 3053
Country 118014 0
Australia
Phone 118014 0
+61383440195
Fax 118014 0
Email 118014 0
j.gunn@unimelb.edu.au
Contact person for public queries
Name 118015 0
Amy Coe
Address 118015 0
University of Melbourne
Department of General Practice
Level 2, 780 Elizabeth St
Melbourne VIC 3004
Country 118015 0
Australia
Phone 118015 0
+61390356335
Fax 118015 0
Email 118015 0
amy.coe@unimelb.edu.au
Contact person for scientific queries
Name 118016 0
Cath Kaylor-Hughes
Address 118016 0
University of Melbourne,
Department of General Practice
Level 2, 780 Elizabeth St
Melbourne VIC 3004
Country 118016 0
Australia
Phone 118016 0
+61383444921
Fax 118016 0
Email 118016 0
cath.kaylorhughes@unimelb.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
IPD will not be available publicly due to confidential information being collected as part of the trial. Data collected as part of the trial will be for research purposes only.


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.