Antidepressant Decision Aid for Major Depressive Disorder Patients

Not Applicable

Completed

• Conditions: Depression; Depressive Disorder, Major; Mood Disorders; Depressive Symptoms
• Interventions: Other: Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM); Other: Booklet of Scripts of Doctors

• Registration Number: NCT04761757
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Study First Submitted: 2021-01-24
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 752

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)	-
Control Arm	Booklet of Scripts of Doctors	-

Primary Outcome Measures

Name	Time	Method
Preparation for Decision Making_Physician Perspective	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	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	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	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.

Trial Locations

Locations (17)

A. H. Lee Specialist Clinic; 🇲🇾 Petaling Jaya, Selangor, Malaysia

Hospital Putrajaya; 🇲🇾 Putrajaya, Malaysia

Hospital Sultanah Nur Zahirah; 🇲🇾 Kuala Terengganu, Terengganu, Malaysia

Pusat Perubatan Universiti Kebangsaan Malaysia; 🇲🇾 Kuala Lumpur, Malaysia

University of Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist; 🇲🇾 Kuala Lumpur, Malaysia

Hospital Pusrawi; 🇲🇾 Kuala Lumpur, Malaysia

Hospital Permai; 🇲🇾 Johor Bahru, Johor, Malaysia

Sultanah Aminah Hospital; 🇲🇾 Johor Bahru, Johor, Malaysia

Columbia Asia Hospital; 🇲🇾 Nusajaya, Johor, Malaysia

KPJ Ampang Puteri Specialist Hospital; 🇲🇾 Ampang, Kuala Lumpur, Malaysia

Dr Seed Specialist Clinic; 🇲🇾 Kepong, Kuala Lumpur, Malaysia

Hospital Pengajar Universiti Putra Malaysia; 🇲🇾 Serdang, Kuala Lumpur, Malaysia

Hospital Sultan Haji Ahmad Shah; 🇲🇾 Temerloh, Pahang, Malaysia

Hospital Raja Permaisuri Bainun; 🇲🇾 Ipoh, Perak, Malaysia

Hospital Pulau Pinang; 🇲🇾 George Town, Pulau Pinang, Malaysia

Hospital Umum Sarawak; 🇲🇾 Kuching, Sarawak, Malaysia