WiserAD: The Effect of a Structured Online Intervention on Antidepressant Deprescribing in Primary Care

NCT05355025 | Recruiting DMC

• 3 other identifiers: CT19003STOPS: A randomised trial of aGNT 1157337
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Deprescribing; Antidepressant; Tapering; Primary Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Patient Health Questionnaire (PHQ-9)

  Baseline, 3-, 6-, 12-, 18- and 24-months.

• General Anxiety Disorder-7 (GAD-7)

  Baseline, 3-, 6-, 12-, 18- and 24-months.

• Patient Activation Measure (PAM)

  Baseline, 3-, 6-months.

• Assessment of Quality of Life (AQoL-4D)

  Baseline, 3-, 6-, 12-, 18- and 24-months.

• Resource Use Questionnaire (RUQ)

  Baseline, 3-, 6-, 12-, 18- and 24-months.

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: WiserAD

Usual care - Attention Control

EXPERIMENTAL

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: Attention control

Interventions

WiserAD BEHAVIORAL

See "Arms"

Intervention

Attention control BEHAVIORAL

See "Arms"

Usual care - Attention Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Social Media

Melbourne, Australia

RECRUITING

Related Publications (1)

• Coe A, Gunn J, Allnutt Z, Kaylor-Hughes C. Understanding Australian general practice patients' decisions to deprescribe antidepressants in the WiserAD trial: a realist informed approach. BMJ Open. 2024 Feb 13;14(2):e078179. doi: 10.1136/bmjopen-2023-078179.

  PMID: 38355180 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jane Gunn, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Coe

CONTACT

61390356335; amy.coe@unimelb.edu.au

Cath Kaylor-Hughes, PhD

CONTACT

cath.kaylorhughes@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomisation system will generate an email containing details of arm allocation which will be sent to the trial manager. The rest of the research team who will be blind to randomisation will only receive an email stating that a participant has been randomised. 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. Participants will be allocated with equal probability to each treatment arm and stratified by site (GP practice). Only the trial coordinator, or their nominee, will have password access to the randomisation data. Participants will not be blind to treatment group. Arm allocation will remain concealed to the research team until recruitment and follow up are complete. The trial coordinator will not be blind to allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind, parallel-arm, randomised controlled trial

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: May 2, 2022
• Study Start: May 25, 2022
• Primary Completion: July 31, 2024
• Study Completion: August 7, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)