Trial of online support for primary care patients tapering off antidepressant medication
| ISRCTN | ISRCTN11562922 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11562922 |
| ClinicalTrials.gov number | NCT05355025 |
| Secondary identifying numbers | ACTRN126220000567729, NHMRC ID no. 1157337 |
- Submission date
- 04/04/2022
- Registration date
- 05/05/2022
- Last edited
- 15/02/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
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.
Who can participate?
Patients aged 18-75 years, who have been stable on their ADs for <=12 months, with no or mild depressive symptoms and no history of recurrent depression.
What does the study involve?
All participants will receive a phone call from the study team one week after randomisation.
Participants allocated to the intervention arm will be provided with a personal login code for the study web portal and 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. 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. 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. Participants allocated to the usual care arm will receive usual care plus attention control which comprises a link to the beyondblue website and directed to the AD factsheet. Participants will not receive any instructions regarding their personal AD use (i.e. they will not be advised to cease or continue). Both arms will receive reminders to complete their research follow up measures online (or by phone if they prefer) at 3, 6, 12, 18 and 24 months.
What are the possible benefits and risk of participating?
WiserAD will provide AD users with the opportunity to reflect on their emotional health and well-being and current need for antidepressant medication. This will also help us to find out if the WiserAD support tool is effective. We do not anticipate any risks, side-effects, or discomforts. However, if patients are asked to taper (reduce down) their medication as part of the trial, we will monitor how well they are coping with this through a daily update from the WiserAD tool and the dosage may be adjusted accordingly, in consultation with a GP, who will remain their responsible clinician.
Where is the study run from?
The University of Melbourne, Department of General Practice, Australia.
When is the study starting and how long is it expected to run for?
March 2018 to March 2025
Who is funding the study?
National Health and Medical Research Council (NHMRC; ID no.: 1157337)
Who is the main contact?
Dr Cath Kaylor-Hughes
wiserad-enquiries@unimelb.edu.au
Contact information
Public
Level 2, 780 Elizabeth St
Melbourne
3004
Australia
 ORCID ID |
0000-0003-3723-7645 |
|---|---|
| Phone | +61 3 90356335 |
| amy.coe@unimelb.edu.au |
Scientific
Level 2, 780 Elizabeth St
Melbourne
3004
Australia
| ORCID ID |
0000-0003-3353-4108 |
|---|---|
| Phone | +61 383444921 |
| cath.kaylorhughes@unimelb.edu.au |
Study information
| Study design | Single-blind parallel-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | WiserAD: A randomised trial of a structured online intervention to promote and support antidepressant deprescribing in primary care |
| Study acronym | The WiserAD Study |
| Study hypothesis | WiserAD (a novel, structured approach to deprescribing antidepressants) will be more effective than usual practice in enabling GPs to help primary care patients to cease (or decrease) their antidepressant medication whilst maintaining patient mental health and wellbeing. |
| Ethics approval(s) | Approved 12/08/2021, University of Melbourne Human Research Ethics Committee (HREC, Office of Research Ethics and Integrity, University of Melbourne, VIC 3010, Australia; +61 8344 1376; HumanEthics-Enquiries@unimelb.edu.au), ref: 20558 |
| Condition | Decreasing antidepressant (AD) medication for depression |
| Intervention | 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). Randomisation: The treatment to which a participant is assigned will be determined by a computer generated pseudo-random code using random permuted blocks of varying size, created by the web developers and held on a secure server. Computer generated pseudo-random code using random permuted blocks of varying size, created by the web developers and held on a secure server. Participants will be allocated with equal probability to each treatment arm and stratified by site (GP clinic). |
| Intervention type | Behavioural |
| Primary outcome measure | Proportion of patients successfully ceasing ADs at 6 months where successful cessation is defined as no AD use (as measured by the Resource Use Questionnaire (RUQ)) and the absence of clinically significant depressive symptoms (as measured by the Patient Health Questionnaire 9-item (PHQ-9)). Measured at 3-, 6-, 12-, 18-months post-baseline. Primary outcome is at 6-months post baseline. |
| Secondary outcome measures | 1. Depressive symptoms (PHQ-9) - Measured at baseline, 3-, 6-, 12-, 18months. 2. Anxiety symptoms (GAD-7) - Measured at baseline 3-, 6-, 12-, 18-months. 3. Patient Activation (PAM) - Measured at baseline, 3-, 6-months. 4. Quality of Life (AQoL-4D) - Measured at baseline, 3-, 6-, 12-, 18-months. 5. Health Service Use (Resource Use Questionnaire) - Measured at baseline, 3-, 6-, 12-, 18- months. 6. Beliefs About Medication Questionnaire (BMQ) - Measured at baseline, 3-months. 7. Signs and Symptoms (A study specific 3-item text response measure for patient reported withdrawal symptoms) - Measured at 3-, 6-months. 8. User Engagement Scale-Short Form (UES-SF) - Measured at 3-, 6-months. 9. Accountability Measurement Tool (AMT) - Measured at 3-, 6-months. 10. Medical Benefit Scheme (MBS; health service use) and the Pharmaceutical Benefit Scheme (PBS; pharmaceutical use) data - collected at 11. the completion of the study (for the whole duration of participation in the study (18-months)). 12. Proportion of patients successfully ceasing ADs where successful cessation is defined as no AD use (as measured by the Resource Use Questionnaire (RUQ)) and the absence of clinically significant depressive symptoms (as measured by the Patient Health Questionnaire 9-item (PHQ-9))Measured at 3-, 12-, 18-months post baseline. |
| Overall study start date | 07/03/2018 |
| Overall study end date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 312 |
| Participant inclusion criteria | 1. 18-75 years 2. Stable on AD for >=12m: (no depressive episodes) 3. No history of recurrent depression 4. Sufficient English language proficiency to provide informed consent 5. No or mild depressive symptoms as measured on the Personal Health Questionnaire (PHQ9) 6. Low risk of Suicide or Self-harm 7. Agree to consider reviewing their AD use 8. Agree to be randomized into the study 9. Willing to provide informed consent |
| Participant exclusion criteria | 1. Those currently experiencing a major life event in the next 3 months 2. Currently using ADs for any other health condition (other than depression) 3. Currently using non-SSRI or SNRI ADs, antipsychotics, or other mood stabiliser medication 4. Have no daily access to the internet |
| Recruitment start date | 25/04/2022 |
| Recruitment end date | 31/07/2025 |
Locations
Countries of recruitment
- Australia
Study participating centre
Parkville
3050
Australia
Sponsor information
University/education
Department of General Practice
Level 2, 780 Elizabeth St
Melbourne
3004
Australia
| Phone | +61 490356335 |
|---|---|
| wiserad-enquiries@unimelb.edu.au | |
| Website | http://www.unimelb.edu.au/ |
"ROR" |
https://ror.org/01ej9dk98 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Additional documents to be made available at a later date. Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 13/02/2024 | 15/02/2024 | Yes | No |
Editorial Notes
15/02/2024: Publication reference added.
01/02/2023: Internal review.
04/05/2022: Trial's existence confirmed by The University of Melbourne.
