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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05355025
Registration number
NCT05355025
Ethics application status
Date submitted
30/03/2022
Date registered
2/05/2022
Titles & IDs
Public title
WiserAD: The Effect of a Structured Online Intervention on Antidepressant Deprescribing in Primary Care
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Scientific title
WiserAD: A Randomised Trial of a Structured Online Intervention to Promote and Support Antidepressant Deprescribing in Primary Care.
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Secondary ID [1]
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STOPS: A randomised trial of a
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Secondary ID [2]
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CT19003
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Universal Trial Number (UTN)
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Trial acronym
WiserAD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - WiserAD
BEHAVIORAL - Attention control
Experimental: Intervention - Participants will be provided with a personal login code for the study web portal via automated email and encouraged to complete the initial components of the intervention which seek to determine participants' current support and management strategies and help them to understand their specific antidepressants. 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) Management strategies for withdrawal symptoms and opportunities to discuss the plan with their GP or trusted Mental health worker; ii) Selecting a start time to begin tapering; iii) Print out of the personalised action plan to keep and share with supportive family and/or friends. Participants will also be required to complete a daily check-in through the portal which will check current symptoms and highlight any negative changes in emotional wellbeing, they will also receive texts reminders to complete these tasks.
Experimental: Usual care - Attention Control - Participants allocated to the treatment as usual group 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.
BEHAVIORAL: WiserAD
See "Arms"
BEHAVIORAL: Attention control
See "Arms"
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of patients successfully ceasing ADs at 6-months post baseline
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Assessment method [1]
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Successful cessation is defined as no AD use and the absence of clinically significant depressive symptoms
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Timepoint [1]
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Primary outcome is at 6-months post baseline.
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Secondary outcome [1]
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Patient Health Questionnaire (PHQ-9)
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Assessment method [1]
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9-items, 4-point likert scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with higher scores indicating higher levels of depressive symptoms.
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Timepoint [1]
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Baseline, 3-, 6-, 12-, 18- and 24-months.
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Secondary outcome [2]
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General Anxiety Disorder-7 (GAD-7)
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Assessment method [2]
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7-items, 4-point likert scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-21 with higher scores indicating higher levels of anxiety.
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Timepoint [2]
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Baseline, 3-, 6-, 12-, 18- and 24-months.
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Secondary outcome [3]
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Patient Activation Measure (PAM)
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Assessment method [3]
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13-item measure that assesses patient knowledge, skill, and confidence for self-management. 4-point likert scale ranging from 1 (disagree strongly) to 4 (agree strongly) plus a "not applicable" option. Total PAM score is the raw score is divided by the number of items answered (excepting non-applicable items) and multiplied by 13. Then, this score is transformed to a scale with a theoretical range 0-100.
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Timepoint [3]
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Baseline, 3-, 6-months.
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Secondary outcome [4]
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Assessment of Quality of Life (AQoL-4D)
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Assessment method [4]
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12-item, likert scale (options differ depending on question). Scoring is for 4 dimensions (Independent Living, Mental Health, Relationships, Senses)
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Timepoint [4]
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Baseline, 3-, 6-, 12-, 18- and 24-months.
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Secondary outcome [5]
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Resource Use Questionnaire (RUQ)
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Assessment method [5]
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Study specific questionnaire measuring health resource use (e.g. doctor visits, medications taken).
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Timepoint [5]
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Baseline, 3-, 6-, 12-, 18- and 24-months.
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Secondary outcome [6]
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Signs and Symptoms
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Assessment method [6]
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Study specific questionnaire asking about common AD side effects. Participants can enter up to 3 text response answers about any effects they have experienced.
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Timepoint [6]
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3-, 6-months.
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Secondary outcome [7]
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Beliefs About Medication Questionnaire (BMQ) Antidepressant version
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Assessment method [7]
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18-items, 5-point likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scored across four domains (Specific Beliefs about Antidepressants - Necessity, Specific Beliefs about Antidepressants - Concerns, General beliefs about medicine - Overuse, General beliefs about medicine - Harms).
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Timepoint [7]
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Baseline, 3-months.
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Secondary outcome [8]
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User Engagement Scale-Short Form (UES-SF)
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Assessment method [8]
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12-items, 5-point likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). An overall engagement score can be calculated by adding all of the items together and dividing by twelve.
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Timepoint [8]
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3- and 6-months.
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Secondary outcome [9]
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Accountability Measurement Tool (AMT)
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Assessment method [9]
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12-items, 5-point likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree).
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Timepoint [9]
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3- and 6-months.
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Secondary outcome [10]
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Medical Benefit Scheme (MBS) and the Pharmaceutical Benefit Scheme (PBS) data
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Assessment method [10]
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Government collected data re: prescriptions and health service use for the duration of time in the study.
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Timepoint [10]
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Provided at completion of the study (patient data collected for duration of time in study - up to 2 years).
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Secondary outcome [11]
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Proportion of patients successfully ceasing ADs at 6-months post baseline
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Assessment method [11]
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Successful cessation is defined as no AD use and the absence of clinically significant depressive symptoms.
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Timepoint [11]
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Measured at 3-, 12-, 18-months to track deprescribing adherence.
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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 (PHQ-9)
* 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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Moderate/severe depressive symptoms (PHQ-9 =10) at study entry or history of severe or recurrent depression
* Experienced a major life event in the past 3 months, or foresee one occurring in the next 3 months (e.g. trauma, grief, loss of role, major health issue, financial crisis)
* Continued AD use indicated for other condition (e.g. anxiety)
* Currently prescribed a non-SSRI/SNRI AD, antipsychotic, or mood stabiliser
* No internet access.
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/08/2025
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Actual
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Sample size
Target
312
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Social Media - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The use of antidepressants (ADs) is increasing globally, including within Australia, which has one of the highest rates of AD prescribing. Despite clear benefits for many people, there is reason to believe that the ongoing use of these medications is often not properly monitored or stopped (deprescribed) when a person returns to better Mental health. This trial sets out to test how well an online support tool (WiserAD) can help patients and their general practitioner to manage the careful and appropriate reducing and stopping of antidepressants, in primary care patients.
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Trial website
https://clinicaltrials.gov/study/NCT05355025
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jane Gunn, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amy Coe
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Address
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Country
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Phone
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61390356335
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05355025