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

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: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Other: eMBC; Other: standard MBC

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: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xing Wang; Phone Number: 021-34773528; Email: 478030003@qq.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9(PHQ-9) change scores	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)	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)	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)	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)	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)	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)	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	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	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	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)	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

• Sponsor: Shanghai Mental Health Center
• Collaborators: 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: Principal Investigator: Jun Chen, M.D., Ph.D, Shanghai Mental Health Center(SMHC)

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (ACTUAL): September 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: China; depression; mobile health; clinical trial; cluster trial; randomized; implementation; assessment; WeChat; mixed methods; measurement-based care; scales
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID 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