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Clinical Trials/NCT04761757
NCT04761757
Completed
Not Applicable

Antidepressant Decision Aid for Major Depressive Disorder Patients

University of Malaya17 sites in 1 country752 target enrollmentDecember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Malaya
Enrollment
752
Locations
17
Primary Endpoint
Preparation for Decision Making_Physician Perspective
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
October 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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.

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.

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.

Study Sites (17)

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