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

Shanghai Mental Health Center

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Other: eMBC; Other: standard MBC

Study type: Interventional

Funder types: Other

Identifiers

NCT05527951

2021-77

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,200 participants in 2 patient groups

Enhanced MBC Implementation(eMBC)

Experimental group

Description:

The eMBC implementation arm use our WeChat Easy to Recover from Depression Mini-Program, which consists of mood tracking and lay-coached self-management.

Treatment:

Other: eMBC

Standard MBC Implementation

Active Comparator group

Description:

The standard MBC implementation arm use paper and pencil questionnaires.

Treatment:

Other: standard MBC