Clinical trial NCT04761757: Antidepressant Decision Aid for Major Depressive Disorder Patients
Official title: Antidepressant Decision Aid for Major Depressive Disorder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Symptoms
Depressive Disorder, Major
Mood Disorders
Keywords: Shared decision making
Patient decision aid
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Malaysia
First posted: 2021-02-21
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Shared Decision Making_Patient Perspective
timeFrame: Immediately after the clinical encounter
measure: Shared Decision Making_Physician Perspective
timeFrame: Immediately after the clinical encounter
measure: Preparation for Decision Making_Patient Perspective
timeFrame: Immediately after the clinical encounter
measure: Preparation for Decision Making_Physician Perspective
timeFrame: Immediately after the clinical encounter
Secondary outcomes:
Other outcomes:
Locations:
city: Johor Bahru
country: Malaysia
facility: Hospital Permai
state: Johor
city: Johor Bahru
country: Malaysia
facility: Sultanah Aminah Hospital
state: Johor
city: Nusajaya
country: Malaysia
facility: Columbia Asia Hospital
state: Johor
city: Ampang
country: Malaysia
facility: KPJ Ampang Puteri Specialist Hospital
state: Kuala Lumpur
city: Kepong
country: Malaysia
facility: Dr Seed Specialist Clinic
state: Kuala Lumpur
city: Serdang
country: Malaysia
facility: Hospital Pengajar Universiti Putra Malaysia
state: Kuala Lumpur
city: Temerloh
country: Malaysia
facility: Hospital Sultan Haji Ahmad Shah
state: Pahang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Petaling Jaya
country: Malaysia
facility: A. H. Lee Specialist Clinic
state: Selangor
city: Kuala Terengganu
country: Malaysia
facility: Hospital Sultanah Nur Zahirah
state: Terengganu
city: Kuala Lumpur
country: Malaysia
facility: Hospital Pusrawi
city: Kuala Lumpur
country: Malaysia
facility: Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist
city: Kuala Lumpur
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Putrajaya
country: Malaysia
facility: Hospital Putrajaya
Study officials:
affiliation: University of Malaya
name: Aya Ahmed Abousheishaa
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Ng Chong Guan
role: PRINCIPAL_INVESTIGATOR
References: