Antidepressant Decision Aid for Major Depressive Disorder Patients (ADAM)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 752
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm	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.
Active Comparator: Intervention Arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Malaya
• Collaborators: Ministry of Education, Malaysia
• Investigators: Principal Investigator: Aya Ahmed Abousheishaa, University of Malaya; Principal Investigator: Ng Chong Guan, University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Shared decision making; Patient decision aid
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Depression; Depressive Disorder; Disease; Mood Disorders; Depressive Disorder, Major; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: ADAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No