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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05355025




Registration number
NCT05355025
Ethics application status
Date submitted
30/03/2022
Date registered
2/05/2022
Date last updated
17/04/2024

Titles & IDs
Public title
WiserAD: The Effect of a Structured Online Intervention on Antidepressant Deprescribing in Primary Care
Scientific title
WiserAD: A Randomised Trial of a Structured Online Intervention to Promote and Support Antidepressant Deprescribing in Primary Care.
Secondary ID [1] 0 0
STOPS: A randomised trial of a
Secondary ID [2] 0 0
CT19003
Universal Trial Number (UTN)
Trial acronym
WiserAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - WiserAD
BEHAVIORAL - Attention control

Experimental: Intervention - Participants 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.

Experimental: Usual care - Attention Control - Participants 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.


BEHAVIORAL: WiserAD
See "Arms"

BEHAVIORAL: Attention control
See "Arms"
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients successfully ceasing ADs at 6-months post baseline
Timepoint [1] 0 0
Primary outcome is at 6-months post baseline.
Secondary outcome [1] 0 0
Patient Health Questionnaire (PHQ-9)
Timepoint [1] 0 0
Baseline, 3-, 6-, 12-, 18- and 24-months.
Secondary outcome [2] 0 0
General Anxiety Disorder-7 (GAD-7)
Timepoint [2] 0 0
Baseline, 3-, 6-, 12-, 18- and 24-months.
Secondary outcome [3] 0 0
Patient Activation Measure (PAM)
Timepoint [3] 0 0
Baseline, 3-, 6-months.
Secondary outcome [4] 0 0
Assessment of Quality of Life (AQoL-4D)
Timepoint [4] 0 0
Baseline, 3-, 6-, 12-, 18- and 24-months.
Secondary outcome [5] 0 0
Resource Use Questionnaire (RUQ)
Timepoint [5] 0 0
Baseline, 3-, 6-, 12-, 18- and 24-months.
Secondary outcome [6] 0 0
Signs and Symptoms
Timepoint [6] 0 0
3-, 6-months.
Secondary outcome [7] 0 0
Beliefs About Medication Questionnaire (BMQ) Antidepressant version
Timepoint [7] 0 0
Baseline, 3-months.
Secondary outcome [8] 0 0
User Engagement Scale-Short Form (UES-SF)
Timepoint [8] 0 0
3- and 6-months.
Secondary outcome [9] 0 0
Accountability Measurement Tool (AMT)
Timepoint [9] 0 0
3- and 6-months.
Secondary outcome [10] 0 0
Medical Benefit Scheme (MBS) and the Pharmaceutical Benefit Scheme (PBS) data
Timepoint [10] 0 0
Provided at completion of the study (patient data collected for duration of time in study - up to 2 years).
Secondary outcome [11] 0 0
Proportion of patients successfully ceasing ADs at 6-months post baseline
Timepoint [11] 0 0
Measured at 3-, 12-, 18-months to track deprescribing adherence.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.



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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/08/2025
Actual
Sample size
Target
312
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Social Media - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05355025
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jane Gunn, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Coe
Address 0 0
Country 0 0
Phone 0 0
61390356335
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05355025