Major Depressive DisorderEMBEDNCT05527951
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
A study testing eMBC and standard MBC in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Measurement-based care (MBC) is an evidence-based practice that incorporates routine outcome assessment using validated rating scales to guide collaborative clinical decision-making. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- eMBC and standard MBC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2022to 31 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18-65 years;
- Participants were diagnosed of unipolar depressive disorder by the treating physician based on accepted diagnostic criteria (e.g., CCMD-3, DSM-IV, DSM-5, ICD-10);
- Participants are expected to have a smartphone device available and be proficient in using a smartphone;
- Participants should have a junior high school education or above, have sufficient audio-visual skills, be able to fully understand the research content and have the legal ability to sign informed consent.
Who cannot join
- Presence of obvious violent aggressive behavior or tendencies;
- Participants who are unstable during onset episodes and cannot cooperate in completing the study content;
- Serious suicidal tendencies;
- Inability to carry out effective verbal communication;
- No smartphone;
- Other circumstances that prevented cooperation or completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jun Chen, M.D., Ph.D, 021-34773367, doctorcj2010@gmail.com
About this study
Official title: Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study:A Cluster Randomized Controlled Trial of Enhanced Versus Standard Measurement-Based Care Implementation for Depression
Measurement-based care (MBC) is an evidence-based practice that incorporates routine outcome assessment using validated rating scales to guide collaborative clinical decision-making. Although MBC results in improved outcomes for patients with major depressive disorder (MDD), there are barriers to its broad implementation in clinical settings. The use of "enhanced" MBC (eMBC), with mobile apps that allow patients to track outcomes and engage in self-management via WeChat, may address some of these barriers. The investigators hypothesize that implementation with eMBC using WeChat will be superior to standard MBC implementation using paper-pencil assessments at the clinic, for both implementation and clinical outcomes.
Read the detailed description
The investigators present a trial protocol for a 2-arm cluster randomized controlled trial (RCT) with a hybrid implementation-effectiveness design comparing standard MBC implementation versus eMBC implementation with 6-month follow up in 12 mental health centers in Shanghai, China. The eMBC implementation uses a WeChat mini-program that includes outcome tracking using brief questionnaires and self-management lessons supplemented with support by a lay coach via WeChat.
- Conditions
- Major Depressive Disorder
- Being tested
- eMBC, standard MBC
- Keywords
- measurement-based care, scales, assessment, depression, randomized, cluster trial, implementation, mobile health, WeChat, clinical trial, mixed methods, China
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMBCOther
The experimental group will implement eMBC with our WeChat Easy to Recover from Depression Mini-Program, which consists of mood tracking and lay-coached self-management.
standard MBCOther
The control intervention group will implement standard MBC using paper and pencil questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced MBC Implementation(eMBC) | Experimental | The eMBC implementation arm use our WeChat Easy to Recover from Depression Mini-Program, which consists of mood tracking and lay-coached self-management. Receives: Other: eMBC |
| Standard MBC Implementation | Active comparator | The standard MBC implementation arm use paper and pencil questionnaires. Receives: Other: standard MBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
To evaluate the severity of depressive symptoms by patients. Remission: total score ≤ 4.
Measured: up to 6 months
Proportion of patients with a Patient Health Questionnaire-9 (PHQ-9) score
Proportion of patients with a PHQ-9 score entered in the clinical record.
Measured: up to 6 months
Secondary outcomes (11)
Patient Health Questionnaire-9(PHQ-9) change scores
The changes in PHQ-9 scores and depression categories were determined by subtracting the final PHQ-9 score from the initial PHQ-9 score. Therefore, a negative change in PHQ-9 represents a lessening of depression symptoms while a positive change in PHQ-9 represents an increase in depression symptoms.
Measured: up to 6 months
The Sheehan disability scale (SDS)
To evaluate the functional impairment, including work/study, daily life and family responsibility. The score of each subscale ranged from 0 to 10 which means from no impairment to loss of function.
Measured: up to 6 months
Quality of Life scale (QOL-6)
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
Measured: up to 6 months
EuroQoL 5 Dimensions (EQ-5D)
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
Measured: up to 6 months
Health economic assessment (HEA)
To evaluate the health services utilization. Economic outcomes will include health service utilization data (both mental health- and non-mental health-related) from the HEA and from available EMR/chart records, including health provider encounters, emergency room visits, hospitalizations, diagnostic tests, and prescriptions.
Measured: up to 6 months
Patient Adherence Questionnaire(PAQ)
To evaluate the medication adherence.The PAQ is a two item measure, with the first question assessing level of adherence (quantified as number of days in the past week in which medication was not taken) and item 2 assesses reasons for non-adherence.
Measured: up to 6 months
Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR-P)
To assess the therapeutic relationship between patients and clinicians in community mental health care settings.It contains 12 items and each item is rated on a 5-point Likert scale, with answers ranging from 0 to 4.
Measured: up to 6 months
Proportion of patients who accessed the WeChat Easy to Recover from Depression Mini-Program at least once
Proportion of patients who accessed the WeChat Easy to Recover from Depression Mini-Program at least once.
Measured: up to 6 months
Proportion of patients who completed at least 4 of 6 lessons in Come Back mini-program
Proportion of patients who completed at least 4 of 6 lessons in the Come Back mini-program.Come Back mini-program is a part of the WeChat Easy to Recover from Depression Mini-Program,which consists of 6 weekly lessons based on cognitive-behavioural therapy (CBT) principles.
Measured: up to 6 months
System Usability Scale
To evaluate patient satisfaction by qualitative interviews.Participants are asked to score 10 items with one of five responses that range from Strongly Agree to Strongly disagree.
Measured: up to 6 months
Evidence Based Practice Attitude Scale (EBPAS)
To evaluate clinician satisfaction by qualitative interviews.Participants are asked to score 15 items with one of five responses that range from Not at All to To a Very Great Extent.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start3 Sep 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study protocol involves a 2-arm cluster RCT of enhanced versus standard measurement-based care implementation for depression.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, University of Toronto, University of Melbourne, Boston University, University of California, University of Alberta, Shanghai CDC for Mental Health, Institute of Population Research, Peking University, University of Michigan, Queen's University, Hongkou Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Jun Chen, M.D., Ph.D, Principal investigator, Shanghai Mental Health Center(SMHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527951
- Sponsor's protocol ID
- 2021-77
- Acronym
- EMBED
- Status last verified
- Jul 2022
- First submitted
- 11 Aug 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lam RW, Michalak EE, Murphy JK, Colquhoun H, Ng C, Culpepper L, Dewa CS, Greenshaw AJ, He Y, Kennedy SH, Li X, Liu J, Liu T, Parikh S, Soares CN, Wang Z, Xu Y, Chen J. Standard Versus Enhanced Measurement-Based Care Effectiveness for Depression (EMBED): Protocol for a Cluster Randomized Implementation-Effectiveness Trial. Cureus. 2025 Aug 18;17(8):e90395. doi: 10.7759/cureus.90395. eCollection 2025 Aug.
PubMed 40970017
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study:A Cluster Randomized Controlled Trial of Enhanced Versus Standard Measurement-Based Care Implementation for Depression
- ClinicalTrials.gov ID
- NCT05527951
- Acronym / sponsor ID
- EMBED / 2021-77
- Conditions
- Major Depressive Disorder
- Keywords
- measurement-based care, scales, assessment, depression, randomized, cluster trial, implementation, mobile health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- University of British Columbia, University of Toronto, University of Melbourne, Boston University, University of California, University of Alberta, Shanghai CDC for Mental Health, Institute of Population Research, Peking University, University of Michigan, Queen's University, Hongkou Mental Health Center
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Sep 2022 (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.
Measurement-based care (MBC) is an evidence-based practice that incorporates routine outcome assessment using validated rating scales to guide collaborative clinical decision-making. Although MBC results in improved outcomes for patients with major depressive disorder (MDD), there are barriers to its broad implementation in clinical settings. The use of "enhanced" MBC (eMBC), with mobile apps that allow patients to track outcomes and engage in self-management via WeChat, may address some of these barriers. The investigators hypothesize that implementation with eMBC using WeChat will be superior to standard MBC implementation using paper-pencil assessments at the clinic, for both implementation and clinical outcomes.
Detailed description
The investigators present a trial protocol for a 2-arm cluster randomized controlled trial (RCT) with a hybrid implementation-effectiveness design comparing standard MBC implementation versus eMBC implementation with 6-month follow up in 12 mental health centers in Shanghai, China. The eMBC implementation uses a WeChat mini-program that includes outcome tracking using brief questionnaires and self-management lessons supplemented with support by a lay coach via WeChat.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study protocol involves a 2-arm cluster RCT of enhanced versus standard measurement-based care implementation for depression.
| Arm | Type | Receives |
|---|---|---|
| Enhanced MBC Implementation(eMBC) | Experimental | Other: eMBCThe eMBC implementation arm use our WeChat Easy to Recover from Depression Mini-Program, which consists of mood tracking and lay-coached self-management. |
| Standard MBC Implementation | Active comparator | Other: standard MBCThe standard MBC implementation arm use paper and pencil questionnaires. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women aged 18-65 years;
- Participants were diagnosed of unipolar depressive disorder by the treating physician based on accepted diagnostic criteria (e.g., CCMD-3, DSM-IV, DSM-5, ICD-10);
- Participants are expected to have a smartphone device available and be proficient in using a smartphone;
- Participants should have a junior high school education or above, have sufficient audio-visual skills, be able to fully understand the research content and have the legal ability to sign informed consent.
Key exclusion criteria (6 listed)
- Presence of obvious violent aggressive behavior or tendencies;
- Participants who are unstable during onset episodes and cannot cooperate in completing the study content;
- Serious suicidal tendencies;
- Inability to carry out effective verbal communication;
- No smartphone;
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 |
|---|---|---|
| eMBCThe experimental group will implement eMBC with our WeChat Easy to Recover from Depression Mini-Program, which consists of mood tracking and lay-coached self-management. | Other | Enhanced MBC Implementation(eMBC) |
| standard MBCThe control intervention group will implement standard MBC using paper and pencil questionnaires. | Other | Standard MBC Implementation |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: up to 6 months
To evaluate the severity of depressive symptoms by patients. Remission: total score ≤ 4.
Proportion of patients with a Patient Health Questionnaire-9 (PHQ-9) score
Time frame: up to 6 months
Proportion of patients with a PHQ-9 score entered in the clinical record.
11 secondary outcomes
Patient Health Questionnaire-9(PHQ-9) change scores
Time frame: up to 6 months
The Sheehan disability scale (SDS)
Time frame: up to 6 months
Quality of Life scale (QOL-6)
Time frame: up to 6 months
EuroQoL 5 Dimensions (EQ-5D)
Time frame: up to 6 months
Health economic assessment (HEA)
Time frame: up to 6 months
Patient Adherence Questionnaire(PAQ)
Time frame: up to 6 months
Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR-P)
Time frame: up to 6 months
Proportion of patients who accessed the WeChat Easy to Recover from Depression Mini-Program at least once
Time frame: up to 6 months
Proportion of patients who completed at least 4 of 6 lessons in Come Back mini-program
Time frame: up to 6 months
System Usability Scale
Time frame: up to 6 months
Evidence Based Practice Attitude Scale (EBPAS)
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 40970017Lam RW, Michalak EE, Murphy JK, Colquhoun H, Ng C, Culpepper L, Dewa CS, Greenshaw AJ, He Y, Kennedy SH, Li X, Liu J, Liu T, Parikh S, Soares CN, Wang Z, Xu Y, Chen J. Standard Versus Enhanced Measurement-Based Care Effectiveness for Depression (EMBED): Protocol for a Cluster Randomized Implementation-Effectiveness Trial. Cureus. 2025 Aug 18;17(8):e90395. doi: 10.7759/cureus.90395. eCollection 2025 Aug.
- 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.
Jun Chen, M.D., Ph.D principal investigator
Shanghai Mental Health Center(SMHC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eMBC and standard MBC in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen, M.D., Ph.D (021-34773367, doctorcj2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05527951, which also lists 1 linked publication.
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 Sep 2022; AzTrials last refreshed its copy on 28 Oct 2026.