Structured Online Support to Inform and Assist Antidepressant Deprescribing in Primary Care (WiserAD Tool): Protocol for a Pragmatic Randomized Controlled Trial.

BACKGROUND: The use of antidepressants is increasing globally. Despite their obvious benefits, ongoing use of these medications is often not properly monitored or deprescribed when a person returns to better mental health. In addition, providing prescriptions to those who do not have clinical depression leads to personal and societal cost burdens. OBJECTIVE: This trial aims to assess the clinical effectiveness and cost-effectiveness of an online support tool designed to help patients with mild to no symptoms of depression and their general practitioners manage the careful and appropriate tapering and cessation of antidepressants at 6 months, and compare the effectiveness to that of usual care. METHODS: This stratified, single-blind, parallel, 2-arm, superiority randomized controlled trial includes Australian primary care patients (aged 18-75 years) with mild to no symptoms of depression who have been on antidepressant medication for longer than 12 months. After obtaining informed consent, 340 eligible patients will be randomized in a 1:1 ratio to an active intervention arm and an attention control arm, with stratification by general practice or state of residence, if recruited via social media. Those in the active intervention arm will be asked to reduce their antidepressant use with the aid of a clinically guided online support tool (WiserAD), while those in the attention control arm will continue to receive usual care. Participants in both arms will be provided with information about antidepressants through the Beyond Blue website and followed up at 3, 6, 12, and 18 months to record antidepressant use, depression and anxiety symptom severity, quality of life, and health economic data. An intention-to-treat analysis will determine the clinical effectiveness of the online tool compared with usual care. The primary outcome is the between-arm difference in the proportion of participants who successfully cease medication use at 6 months and have mild or absent depressive symptoms. Cost-consequence and cost-utility analyses will be used to determine the cost-effectiveness of the intervention and its impact on quality of life, and comparisons will be made with usual care. RESULTS: The study was funded by the National Health and Medical Research Council in 2019. At submission of this manuscript in July 2025, 310 participants have been randomized, and recruitment ongoing. The target number of 340 randomized participants was achieved in January 2026. Trial outcomes will be reported in peer-reviewed journals in Febraury 2027. CONCLUSIONS: The WiserAD online support tool assists patients and their general practitioners with deprescribing and may lead to successful cessation of antidepressant medication, resulting in enhanced quality of life and cost savings over the longer term.