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Antidepressant Decision Aid for Major Depressive Disorder Patients

Antidepressant Decision Aid for Major Depressive Disorder Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761757
Acronym
ADAM
Enrollment
752
Registered
2021-02-21
Start date
2019-12-01
Completion date
2020-10-30
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depressive Disorder, Major, Depressive Symptoms, Mood Disorders

Keywords

Shared decision making, Patient decision aid

Brief summary

The purpose of this study is to determine whether Antidepressant Decision Aid for Major Depressive Disorder is feasible and effective in involving patients in the decision-making process when initiating pharmacotherapy.

Detailed description

To examine the ability of the patient decision aid to enhance shared decision making and preparedness to make decisions pertaining to antidepressant therapy. The research team has systematically developed an Antidepressant Decision Aid for Major depressive disorder patients (ADAM) according to the International Patient Decision Aids Standards (IPDAS) and the Ottawa Decision Support Framework. This is a posttest-only study with nonequivalent groups to evaluate the effect of the antidepressant decision aid on patient and physician perception of shared decision making as well as patient preparedness for making pharmacotherapeutic decisions compared usual care.

Interventions

OTHERBooklet of Scripts of Doctors

The Booklet of Scripts for Doctors was used in the control arm. This tool was developed and tested to encourage shared decision-making in prescribing antidepressants within the Malaysian context.

OTHERBooklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)

The Booklet of Scripts for Doctors along with the Antidepressant Decision Aid for Major depressive disorder patients, ADAM, was used in the intervention arm. The decision aid was developed as per the International Patient Decision Aid Standards (IPDAS) criteria to enhance patient understanding of risks and benefits of different antidepressants available within the Malaysian context.

Sponsors

Ministry of Education, Malaysia
CollaboratorOTHER_GOV
University of Malaya
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed with Major Depressive Disorder (MDD) * No psychotic symptoms * Based on psychiatrist's clinical judgement currently in need for antidepressant treatment. * Functional English literacy and language skills (to use the decision aid and fill out the questionnaires) * Provides consent

Exclusion criteria

* Psychosis * Communication barriers (visual impairment, language barrier)

Design outcomes

Primary

MeasureTime frameDescription
Shared Decision Making_Patient PerspectiveImmediately after the clinical encounterThe patient version of the Shared Decision Making scale (SDM-Q-9) measures the extent to which patients are involved in the decision-making process from the patient's perspective. It consists of nine items rated on a six-point Likert-type scale fromcompletely disagree= tocompletely agree=. Adding the score of all the items leads to a raw total between 0 and 45. Multiplying the raw score by 20/9 provides a transformed score ranging from 0 to 100, higher scores indicate a greater extent of SDM.
Shared Decision Making_Physician PerspectiveImmediately after the clinical encounterThe physician version of Shared Decision Making scale (SDM-Q-Doc) measures the extent to which patients are involved in the decision-making process from the physician's perspective. It consists of nine items rated on a six-point Likert-type scale fromcompletely disagree= tocompletely agree=. Adding the score of all the items leads to a raw total between 0 and 45. Multiplying the raw score by 20/9 provided a transformed score ranging from 0 to 100, higher scores indicate a greater extent of SDM.
Preparation for Decision Making_Patient PerspectiveImmediately after the clinical encounterThe patient version of the Preparation for Decision-Making Scale (PDMS) assesses the patient's perception of how the PDA helped them recognize that a decision needs to be made, preparing them to communicate with their practitioner and promote patient involvement in the decision-making process. Higher scores indicate a higher perceived level of preparation for decision making.
Preparation for Decision Making_Physician PerspectiveImmediately after the clinical encounterThe physician version of the Preparation for Decision-Making Scale (PDMS) assesses the physician's perception of how the PDA helped patients recognize that a decision needs to be made, preparing them to communicate with their practitioner and promote patient involvement in the decision-making process. Higher scores indicate a higher perceived level of preparation for decision making.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026