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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-03

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study protocol involves a 2-arm cluster RCT of enhanced versus standard measurement-based care implementation for depression.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

eMBC

Intervention Type OTHER

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 MBC Implementation

The standard MBC implementation arm use paper and pencil questionnaires.

Group Type ACTIVE_COMPARATOR

standard MBC

Intervention Type OTHER

The control intervention group will implement standard MBC using paper and pencil questionnaires.

Interventions

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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.

Intervention Type OTHER

standard MBC

The control intervention group will implement standard MBC using paper and pencil questionnaires.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No