Depression Clinical Trial
— WiserADOfficial 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.
Status | Recruiting |
Enrollment | 312 |
Est. completion date | August 7, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 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. 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Social Media | Melbourne |
Lead Sponsor | Collaborator |
---|---|
University of Melbourne | National Health and Medical Research Council, Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Primary outcome is at 6-months post baseline. | |
Secondary | 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. | Baseline, 3-, 6-, 12-, 18- and 24-months. | |
Secondary | 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. | Baseline, 3-, 6-, 12-, 18- and 24-months. | |
Secondary | 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. | Baseline, 3-, 6-months. | |
Secondary | 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) | Baseline, 3-, 6-, 12-, 18- and 24-months. | |
Secondary | Resource Use Questionnaire (RUQ) | Study specific questionnaire measuring health resource use (e.g. doctor visits, medications taken). | Baseline, 3-, 6-, 12-, 18- and 24-months. | |
Secondary | 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. | 3-, 6-months. | |
Secondary | 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). | Baseline, 3-months. | |
Secondary | 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. | 3- and 6-months. | |
Secondary | Accountability Measurement Tool (AMT) | 12-items, 5-point likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). | 3- and 6-months. | |
Secondary | 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. | Provided at completion of the study (patient data collected for duration of time in study - up to 2 years). | |
Secondary | 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 at 3-, 12-, 18-months to track deprescribing adherence. |
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