DepressionADAMNCT04761757
Antidepressant Decision Aid for Major Depressive Disorder Patients
A study testing Booklet of Scripts of Doctors and Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM) in people with Depression and Depressive Symptoms, run by University of Malaya at 17 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Symptoms, Depressive Disorder, Major
- What is being tested?
- Booklet of Scripts of Doctors and Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 17 sitesMalaysia
- Study dates
- 1 Dec 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychosis
- Communication barriers (visual impairment, language barrier)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Malaysia17 sites
KPJ Ampang Puteri Specialist Hospital
Ampang, Kuala Lumpur
Hospital Pulau Pinang
George Town, Pulau Pinang
Hospital Raja Permaisuri Bainun
Ipoh, Perak
Columbia Asia Hospital
Iskandar Puteri, Johor
Hospital Permai
Johor Bahru, Johor
Sultanah Aminah Hospital
Johor Bahru, Johor
Dr Seed Specialist Clinic
Kepong, Kuala Lumpur
Hospital Pusrawi
Kuala Lumpur
Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist
Kuala Lumpur
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur
University of Malaya Medical Centre
Kuala Lumpur
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu
Hospital Umum Sarawak
Kuching, Sarawak
A. H. Lee Specialist Clinic
Petaling Jaya, Selangor
Hospital Putrajaya
Putrajaya
Hospital Pengajar Universiti Putra Malaysia
Serdang, Kuala Lumpur
Hospital Sultan Haji Ahmad Shah
Temerluh, Pahang
About this study
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.
Read the 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.
- Being tested
- Booklet of Scripts of Doctors, Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)
- Keywords
- Shared decision making, Patient decision aid
- Medical subject headings
- Depression, Depressive Disorder, Major, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Booklet of Scripts of DoctorsOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Not described Receives: Other: Booklet of Scripts of Doctors |
| Intervention Arm | Active comparator | Not described Receives: Other: Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the clinical encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Dec 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Malaysia
- Responsible party
- Sponsor
- Investigators
- Aya Ahmed Abousheishaa, Principal investigator, University of MalayaNg Chong Guan, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761757
- Sponsor's protocol ID
- ADAM
- Acronym
- ADAM
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Decision Aid for Major Depressive Disorder Patients
- ClinicalTrials.gov ID
- NCT04761757
- Acronym / sponsor ID
- ADAM / ADAM
- Keywords
- Shared decision making, Patient decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Ministry of Education, Malaysia
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Booklet of Scripts of Doctors |
| Intervention Arm | Active comparator | Other: Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Psychosis
- Communication barriers (visual impairment, language barrier)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Booklet of Scripts of DoctorsThe "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. | Other | Control Arm |
| 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. | Other | Intervention Arm |
Primary outcome
Shared Decision Making_Patient Perspective
Time frame: 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.
Shared Decision Making_Physician Perspective
Time frame: 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.
Preparation for Decision Making_Patient Perspective
Time frame: 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.
Preparation for Decision Making_Physician Perspective
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aya Ahmed Abousheishaa principal investigator
University of Malaya
Ng Chong Guan principal investigator
University of Malaya
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booklet of Scripts of Doctors and Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM) in people with Depression and Depressive Symptoms, run by University of Malaya at 17 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making_Patient Perspective (time frame: Immediately after the clinical encounter). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.