Antidepressant Decision Aid for Major Depressive Disorder Patients

NCT ID: NCT04761757

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-10-30

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.

Conditions

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Depression Depressive Symptoms Depressive Disorder, Major Mood Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control Arm

Group Type ACTIVE_COMPARATOR

Booklet of Scripts of Doctors

Intervention Type 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.

Intervention Arm

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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Booklet of Scripts of Doctors

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.

Intervention Type OTHER

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

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 Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Education, Malaysia

OTHER_GOV

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aya Ahmed Abousheishaa

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Ng Chong Guan

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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Columbia Asia Hospital

Iskandar Puteri, Johor, Malaysia

Site Status

Hospital Permai

Johor Bahru, Johor, Malaysia

Site Status

Sultanah Aminah Hospital

Johor Bahru, Johor, Malaysia

Site Status

KPJ Ampang Puteri Specialist Hospital

Ampang, Kuala Lumpur, Malaysia

Site Status

Dr Seed Specialist Clinic

Kepong, Kuala Lumpur, Malaysia

Site Status

Hospital Pengajar Universiti Putra Malaysia

Serdang, Kuala Lumpur, Malaysia

Site Status

Hospital Sultan Haji Ahmad Shah

Temerluh, Pahang, Malaysia

Site Status

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Site Status

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Site Status

Hospital Umum Sarawak

Kuching, Sarawak, Malaysia

Site Status

A. H. Lee Specialist Clinic

Petaling Jaya, Selangor, Malaysia

Site Status

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, Malaysia

Site Status

Hospital Pusrawi

Kuala Lumpur, , Malaysia

Site Status

Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist

Kuala Lumpur, , Malaysia

Site Status

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, , Malaysia

Site Status

University of Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Hospital Putrajaya

Putrajaya, , Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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ADAM

Identifier Type: -

Identifier Source: org_study_id

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