None listed
Conditions
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. It is anticipated that WiserAD (a novel, structured approach to deprescribing ADs) is more effective than usual practice in enabling GPs to help primary care patients to cease (or decrease) their AD medication whilst maintaining their mental health and wellbeing.
Interventions
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
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).
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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
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
Outcome results
None listed