Depression Clinical Trial
— ADAMOfficial title:
Antidepressant Decision Aid for Major Depressive Disorder Patients
NCT number | NCT04761757 |
Other study ID # | ADAM |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | October 30, 2020 |
Verified date | February 2021 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Malaya | Ministry of Education, Malaysia |
Malaysia,
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 |
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