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DepressionWiserADNCT05355025

WiserAD: The Effect of a Structured Online Intervention on Antidepressant Deprescribing in Primary Care

A study testing WiserAD in people with Depression, run by University of Melbourne at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Depression
What is being tested?
WiserAD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
1 siteAustralia
Study dates
25 May 2022to 7 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Agree to consider reviewing their AD use
  • Agree to be randomized into the study
  • Willing to provide informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Cath Kaylor-Hughes, PhD contact

cath.kaylorhughes@unimelb.edu.au

Australia1 site, 1 recruiting
  • Social Media

    Melbourne

    WiserAD

    Recruiting

Other trials in Australia

About this study

Official title: WiserAD: A Randomised Trial of a Structured Online Intervention to Promote and Support Antidepressant Deprescribing in Primary Care.

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.

Read the detailed description

Antidepressants (ADs) have significantly improved the health and wellbeing for very many people and their success in enabling those with depression to retain their quality of life has undoubtedly led to their widespread use around the globe. However, the success of ADs has also led to a significant and unnecessary clinical and economic burden on the healthcare system and patients, through over prescribing, most often in cases when they are no longer of therapeutic use.

Such inappropriate medicine use (defined as use that is going against clinical guidelines) is a significant financial and clinical challenge for healthcare providers globally. Recent figures show that alongside the US, UK and parts of Northern Europe, Australia now has one of the world's highest AD prescribing rates with a total cost of over $200 million per year. In 2015-2016 alone there were more AD prescriptions than people: 24.72 million - up 20% since 2012. Significantly, much of this this is due to an excess of long term users rather than an increase in the number of people being newly diagnosed with major depressive disorder (MDD) or other disorders for which ADs are prescribed (e.g. anxiety). In a recent study by this group a cohort of almost 800 primary care patients with depressive symptoms showed that only 15% of long term users satisfied clinical criteria for long term AD use. There is relatively little research that explores the long term effects of AD use but there are indications that it can be harmful. In many cases, long term use can be linked to a range of severe side effects including increased risk of cardiovascular events, gastrointestinal bleeding and diabetes.

Psychological dependence is another problem facing users and stems from a perceived need to take ADs for fear of a relapse. That fear, shared by doctors, explains why AD use is unnecessarily protracted, even though it may undermine patients' autonomy and resilience, becoming less likely to self-manage or willing to stop their AD medication. Crucially, the evidence for relapse comes primarily from studies on AD users for whom guidelines recommend continued treatment (those who meet diagnostic criteria for moderate to severe major depressive disorder and have been receiving AD treatment for less than 12 months). In those with milder symptoms epidemiological research suggests that long-term AD use does not increase the likelihood of relapse and that that inappropriate long-term AD users can safely cease their medication. These findings are supported by a randomised controlled trial of AD cessation for primary care patients without current depression which showed a much smaller difference in relapse than previously thought.

Limiting AD use only to cases in which it is clinically indicated is in line with quality prescribing and will help to reduce costs and associated adverse events as well as the potential benefit of improving long-term mental health outcomes for patients. Although they are not addictive research has shown that ADs are more difficult to cease than other medications and previous studies have demonstrated limited success in deprescribing trials of antidepressants compared to other medications suggesting that a more intensive, patient-focused intervention is required to support successful de-prescribing. The WiserAD study will test whether a novel, structured approach to deprescribing antidepressants is more effective than usual practice in enabling GPs to help patients cease (or decrease) their AD medication whilst maintaining their mental health and wellbeing.

Conditions
Depression
Being tested
WiserAD, Attention control
Keywords
Deprescribing, Antidepressant, Tapering, Primary Care
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WiserADBehavioural

    See "Arms"

  • Attention controlBehavioural

    See "Arms"

Study groups in NCT05355025
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: WiserAD
Usual care - Attention ControlExperimentalParticipants 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.
Receives: Behavioral: Attention control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients successfully ceasing ADs at 6-months post baseline

    Successful cessation is defined as no AD use and the absence of clinically significant depressive symptoms

    Measured: Primary outcome is at 6-months post baseline.

Secondary outcomes (11)
  1. Patient Health Questionnaire (PHQ-9)

    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.

    Measured: Baseline, 3-, 6-, 12-, 18- and 24-months.

  2. General Anxiety Disorder-7 (GAD-7)

    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.

    Measured: Baseline, 3-, 6-, 12-, 18- and 24-months.

  3. Patient Activation Measure (PAM)

    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.

    Measured: Baseline, 3-, 6-months.

  4. Assessment of Quality of Life (AQoL-4D)

    12-item, likert scale (options differ depending on question). Scoring is for 4 dimensions (Independent Living, Mental Health, Relationships, Senses)

    Measured: Baseline, 3-, 6-, 12-, 18- and 24-months.

  5. Resource Use Questionnaire (RUQ)

    Study specific questionnaire measuring health resource use (e.g. doctor visits, medications taken).

    Measured: Baseline, 3-, 6-, 12-, 18- and 24-months.

  6. Signs and Symptoms

    Study specific questionnaire asking about common AD side effects. Participants can enter up to 3 text response answers about any effects they have experienced.

    Measured: 3-, 6-months.

  7. Beliefs About Medication Questionnaire (BMQ) Antidepressant version

    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).

    Measured: Baseline, 3-months.

  8. User Engagement Scale-Short Form (UES-SF)

    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.

    Measured: 3- and 6-months.

  9. Accountability Measurement Tool (AMT)

    12-items, 5-point likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree).

    Measured: 3- and 6-months.

  10. Medical Benefit Scheme (MBS) and the Pharmaceutical Benefit Scheme (PBS) data

    Government collected data re: prescriptions and health service use for the duration of time in the study.

    Measured: Provided at completion of the study (patient data collected for duration of time in study - up to 2 years).

  11. Proportion of patients successfully ceasing ADs at 6-months post baseline

    Successful cessation is defined as no AD use and the absence of clinically significant depressive symptoms.

    Measured: Measured at 3-, 12-, 18-months to track deprescribing adherence.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start25 May 2022
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion7 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single blind, parallel-arm, randomised controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
312 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05355025
Sponsor's protocol ID
CT19003
Other IDs
STOPS: A randomised trial of a, GNT 1157337
Acronym
WiserAD
Status last verified
Apr 2024
First submitted
30 Mar 2022
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Kaylor-Hughes C, Coe A, Chondros P, Densley K, Fletcher S, Chatterton ML, Hoyer D, Chen T, Ng C, Mangin D, Kendrick T, Allnutt Z, Gunn Ao J. Structured Online Support to Inform and Assist Antidepressant Deprescribing in Primary Care (WiserAD Tool): Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 7;15:e81858. doi: 10.2196/81858.

    PubMed 42566288
  • Coe A, Gunn J, Allnutt Z, Kaylor-Hughes C. Understanding Australian general practice patients' decisions to deprescribe antidepressants in the WiserAD trial: a realist informed approach. BMJ Open. 2024 Feb 13;14(2):e078179. doi: 10.1136/bmjopen-2023-078179.

    PubMed 38355180

Questions about this trial

What is this clinical trial studying?

A study testing WiserAD in people with Depression, run by University of Melbourne at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amy Coe (61390356335, amy.coe@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients successfully ceasing ADs at 6-months post baseline (time frame: Primary outcome is at 6-months post baseline.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05355025, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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