Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study (EMBED)

September 16, 2022 updated by: Shanghai Mental Health Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women aged 18-65 years;
  2. 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);
  3. Participants are expected to have a smartphone device available and be proficient in using a smartphone;
  4. 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.

Exclusion Criteria:

  1. Presence of obvious violent aggressive behavior or tendencies;
  2. Participants who are unstable during onset episodes and cannot cooperate in completing the study content;
  3. Serious suicidal tendencies;
  4. Inability to carry out effective verbal communication;
  5. No smartphone;
  6. Other circumstances that prevented cooperation or completion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Enhanced MBC Implementation(eMBC)
The eMBC implementation arm use our WeChat Easy to Recover from Depression Mini-Program, which consists of mood tracking and lay-coached self-management.
Other: eMBC
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.
ACTIVE_COMPARATOR: Standard MBC Implementation
The standard MBC implementation arm use paper and pencil questionnaires.
Other: standard MBC
The control intervention group will implement standard MBC using paper and pencil questionnaires.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 6 months
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.
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9(PHQ-9) change scores
Time Frame: up to 6 months
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.
up to 6 months
The Sheehan disability scale (SDS)
Time Frame: up to 6 months
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.
up to 6 months
Quality of Life scale (QOL-6)
Time Frame: up to 6 months
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
up to 6 months
EuroQoL 5 Dimensions (EQ-5D)
Time Frame: up to 6 months
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
up to 6 months
Health economic assessment (HEA)
Time Frame: up to 6 months
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.
up to 6 months
Patient Adherence Questionnaire(PAQ)
Time Frame: up to 6 months
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.
up to 6 months
Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR-P)
Time Frame: up to 6 months
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.
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 accessed the WeChat Easy to Recover from Depression Mini-Program at least once.
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
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.
up to 6 months
System Usability Scale
Time Frame: up to 6 months
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.
up to 6 months
Evidence Based Practice Attitude Scale (EBPAS)
Time Frame: up to 6 months
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.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston University
University of British Columbia
University of Michigan
University of Alberta
University of Toronto
Queen's University
University of California
University of Melbourne
Shanghai CDC for Mental Health
Institute of Population Research, Peking University
Hongkou Mental Health Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jun Chen, M.D., Ph.D, Shanghai Mental Health Center(SMHC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-77

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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