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

NCT05527951 | Unknown DMC

• 1 other identifier: 2021-77
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Major Depressive Disorder

Keywords

measurement-based care; scales; assessment; depression; randomized; cluster trial; implementation; mobile health; WeChat; clinical trial; mixed methods; China

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire-9 (PHQ-9)

  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

  Proportion of patients with a PHQ-9 score entered in the clinical record.

  up to 6 months

Secondary Outcomes (11)

• Patient Health Questionnaire-9(PHQ-9) change scores

  up to 6 months

• The Sheehan disability scale (SDS)

  up to 6 months

• Quality of Life scale (QOL-6)

  up to 6 months

• EuroQoL 5 Dimensions (EQ-5D)

  up to 6 months

• Health economic assessment (HEA)

  up to 6 months

Study Arms (2)

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.

Other: eMBC

Standard MBC Implementation

ACTIVE COMPARATOR

The standard MBC implementation arm use paper and pencil questionnaires.

Other: standard MBC

Interventions

eMBC 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.

Enhanced MBC Implementation(eMBC)

standard MBC OTHER

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

Standard MBC Implementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• University of British Columbia: collaborator
• University of Toronto: collaborator
• University of Melbourne: collaborator
• Boston University: collaborator
• University of California: collaborator
• University of Alberta: collaborator
• Shanghai CDC for Mental Health: collaborator
• Institute of Population Research, Peking University: collaborator
• University of Michigan: collaborator
• Queen's University: collaborator
• Hongkou Mental Health Center: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40970017 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jun Chen, M.D., Ph.D

  Shanghai Mental Health Center(SMHC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Chen, M.D., Ph.D

CONTACT

021-34773367; doctorcj2010@gmail.com

Xing Wang

CONTACT

021-34773528; 478030003@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: September 6, 2022
• Study Start: September 3, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)