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Completed

NCT Number: NCT04761757

Antidepressant Decision Aid for Major Depressive Disorder Patients

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.

Completed

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Depressive Symptoms Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia Asia Hospital, Iskandar Puteri, Johor, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Booklet of Scripts of Doctors

Other

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.

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

Other

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.

Primary outcomes

  1. Shared Decision Making_Patient Perspective

    Time frame: Immediately after the clinical encounter

    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 from"completely disagree=" to"completely 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.

  2. Shared Decision Making_Physician Perspective

    Time frame: Immediately after the clinical encounter

    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 from"completely disagree=" to"completely 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.

  3. Preparation for Decision Making_Patient Perspective

    Time frame: Immediately after the clinical encounter

    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.

  4. Preparation for Decision Making_Physician Perspective

    Time frame: Immediately after the clinical encounter

    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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Collaborators

  • Ministry of Education, Malaysia

Registry information

Acronym: ADAM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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