ADAM: Antidepressant Decision Aid for Major Depressive Disorder Patients

• Sponsor: University of Malaya (Other)
• Overall Status: Completed
• CT.gov ID: NCT04761757
• Collaborator: Ministry of Education, Malaysia (Other)
• Enrollment: 752
• Locations: 17
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site: 44.2
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Depressive Symptoms; Depressive Disorder, Major; Mood Disorders	Other: Booklet of Scripts of Doctors; Other: Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 752 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Antidepressant Decision Aid for Major Depressive Disorder Patients
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: Oct 30, 2020
• Actual Study Completion Date: Oct 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Shared Decision Making_Patient Perspective [Immediately after the clinical encounter]

   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.

2. Shared Decision Making_Physician Perspective [Immediately after the clinical encounter]

   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.

3. Preparation for Decision Making_Patient Perspective [Immediately after the clinical encounter]

   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.

4. Preparation for Decision Making_Physician Perspective [Immediately after the clinical encounter]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Permai	Johor Bahru	Johor	Malaysia
2	Sultanah Aminah Hospital	Johor Bahru	Johor	Malaysia
3	Columbia Asia Hospital	Nusajaya	Johor	Malaysia
4	KPJ Ampang Puteri Specialist Hospital	Ampang	Kuala Lumpur	Malaysia
5	Dr Seed Specialist Clinic	Kepong	Kuala Lumpur	Malaysia
6	Hospital Pengajar Universiti Putra Malaysia	Serdang	Kuala Lumpur	Malaysia
7	Hospital Sultan Haji Ahmad Shah	Temerloh	Pahang	Malaysia
8	Hospital Raja Permaisuri Bainun	Ipoh	Perak	Malaysia
9	Hospital Pulau Pinang	George Town	Pulau Pinang	Malaysia
10	Hospital Umum Sarawak	Kuching	Sarawak	Malaysia
11	A. H. Lee Specialist Clinic	Petaling Jaya	Selangor	Malaysia
12	Hospital Sultanah Nur Zahirah	Kuala Terengganu	Terengganu	Malaysia
13	Hospital Pusrawi	Kuala Lumpur		Malaysia
14	Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist	Kuala Lumpur		Malaysia
15	Pusat Perubatan Universiti Kebangsaan Malaysia	Kuala Lumpur		Malaysia
16	University of Malaya Medical Centre	Kuala Lumpur		Malaysia
17	Hospital Putrajaya	Putrajaya		Malaysia

Sponsors and Collaborators

• University of Malaya
• Ministry of Education, Malaysia

Investigators

• Principal Investigator: Aya Ahmed Abousheishaa, University of Malaya
• Principal Investigator: Ng Chong Guan, University of Malaya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Malaya
• ClinicalTrials.gov Identifier: NCT04761757
• Other Study ID Numbers: ADAM
• First Posted: Feb 21, 2021
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Malaya: Shared decision making; Patient decision aid
• Additional relevant MeSH terms: Disease; Depression; Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Antidepressive Agents

Study Results

No Results Posted as of Feb 21, 2021