Antidepressant Decision Aid for Major Depressive Disorder Patients

Depression Clinical Trial

— ADAM  

Official title:

Antidepressant Decision Aid for Major Depressive Disorder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761757
• Other study ID #: ADAM
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2021
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Symptoms
• Disease
• Mood Disorders

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Malaysia	KPJ Ampang Puteri Specialist Hospital	Ampang	Kuala Lumpur
Malaysia	Hospital Pulau Pinang	George Town	Pulau Pinang
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh	Perak
Malaysia	Hospital Permai	Johor Bahru	Johor
Malaysia	Sultanah Aminah Hospital	Johor Bahru	Johor
Malaysia	Dr Seed Specialist Clinic	Kepong	Kuala Lumpur
Malaysia	Hospital Pusrawi	Kuala Lumpur
Malaysia	Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist	Kuala Lumpur
Malaysia	Pusat Perubatan Universiti Kebangsaan Malaysia	Kuala Lumpur
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Sultanah Nur Zahirah	Kuala Terengganu	Terengganu
Malaysia	Hospital Umum Sarawak	Kuching	Sarawak
Malaysia	Columbia Asia Hospital	Nusajaya	Johor
Malaysia	A. H. Lee Specialist Clinic	Petaling Jaya	Selangor
Malaysia	Hospital Putrajaya	Putrajaya
Malaysia	Hospital Pengajar Universiti Putra Malaysia	Serdang	Kuala Lumpur
Malaysia	Hospital Sultan Haji Ahmad Shah	Temerloh	Pahang

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaya	Ministry of Education, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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