Clinical trial NCT05527951: Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: measurement-based care
scales
assessment
depression
randomized
cluster trial
implementation
mobile health
WeChat
clinical trial
mixed methods
China
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: University of Toronto
name: University of Melbourne
name: Boston University
name: University of California
name: University of Alberta
name: Shanghai CDC for Mental Health
name: Institute of Population Research, Peking University
name: University of Michigan
name: Queen's University
name: Hongkou Mental Health Center
First posted: 2022-09-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study protocol involves a 2-arm cluster RCT of enhanced versus standard measurement-based care implementation for depression.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: up to 6 months
measure: Proportion of patients with a Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: up to 6 months
Secondary outcomes:
measure: Patient Health Questionnaire-9(PHQ-9) change scores
timeFrame: up to 6 months
measure: The Sheehan disability scale (SDS)
timeFrame: up to 6 months
measure: Quality of Life scale (QOL-6)
timeFrame: up to 6 months
measure: EuroQoL 5 Dimensions (EQ-5D)
timeFrame: up to 6 months
measure: Health economic assessment (HEA)
timeFrame: up to 6 months
measure: Patient Adherence Questionnaire(PAQ)
timeFrame: up to 6 months
measure: Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR-P)
timeFrame: up to 6 months
measure: Proportion of patients who accessed the WeChat Easy to Recover from Depression Mini-Program at least once
timeFrame: up to 6 months
measure: Proportion of patients who completed at least 4 of 6 lessons in Come Back mini-program
timeFrame: up to 6 months
measure: System Usability Scale
timeFrame: up to 6 months
measure: Evidence Based Practice Attitude Scale (EBPAS)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center(SMHC)
name: Jun Chen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: