Antidepressant Decision Aid for Major Depressive Disorder Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antidepressant Decision Aid for Major Depressive Disorder Patients

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

Intervention / Treatment
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* Other: Booklet of Scripts of Doctors
* Other: Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br> | Other: Booklet of Scripts of Doctors<br>* 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.<br>|
| Active Comparator: Intervention Arm<br> | Other: Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shared Decision Making_Patient Perspective | The 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. | Immediately after the clinical encounter | 
| Shared Decision Making_Physician Perspective | The 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. | Immediately after the clinical encounter | 
| Preparation for Decision Making_Patient Perspective | The 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. | Immediately after the clinical encounter | 
| Preparation for Decision Making_Physician Perspective | The 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. | Immediately after the clinical encounter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared decision making, Patient decision aid