NCT04761757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
752

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

January 24, 2021

Last Update Submit

February 17, 2021

Conditions

DepressionDepressive SymptomsDepressive Disorder, MajorMood Disorders

Keywords

Shared decision makingPatient decision aid

Outcome Measures

Primary Outcomes (4)

  • 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 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.

    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 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.

    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

Study Arms (2)

Control Arm

ACTIVE COMPARATOR
Other: Booklet of Scripts of Doctors

Intervention Arm

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

Interventions

Booklet of Scripts of DoctorsOTHER

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.

Control Arm
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.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Columbia Asia Hospital

Iskandar Puteri, Johor, Malaysia

Location

Hospital Permai

Johor Bahru, Johor, Malaysia

Location

Sultanah Aminah Hospital

Johor Bahru, Johor, Malaysia

Location

KPJ Ampang Puteri Specialist Hospital

Ampang, Kuala Lumpur, Malaysia

Location

Dr Seed Specialist Clinic

Kepong, Kuala Lumpur, Malaysia

Location

Hospital Pengajar Universiti Putra Malaysia

Serdang, Kuala Lumpur, Malaysia

Location

Hospital Sultan Haji Ahmad Shah

Temerluh, Pahang, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Location

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Location

Hospital Umum Sarawak

Kuching, Sarawak, Malaysia

Location

A. H. Lee Specialist Clinic

Petaling Jaya, Selangor, Malaysia

Location

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, Malaysia

Location

Hospital Pusrawi

Kuala Lumpur, Malaysia

Location

Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist

Kuala Lumpur, Malaysia

Location

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, Malaysia

Location

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Hospital Putrajaya

Putrajaya, Malaysia

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorMood Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMental Disorders

Study Officials

  • Aya Ahmed Abousheishaa

    University of Malaya

    PRINCIPAL INVESTIGATOR

  • Ng Chong Guan

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2021

First Posted

February 21, 2021

Study Start

December 1, 2019

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

MY(17)