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

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
eMBC
standard MBC
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Major Depressive Disorder focused on measuring measurement-based care, scales, assessment, depression, randomized, cluster trial, implementation, mobile health, WeChat, clinical trial, mixed methods, China

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced MBC Implementation(eMBC)

Standard MBC Implementation

Arm 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.

The standard MBC implementation arm use paper and pencil questionnaires.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9)
To evaluate the severity of depressive symptoms by patients. Remission: total score ≤ 4.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 11, 2022
Last Updated
September 16, 2022
Sponsor
Shanghai Mental Health Center
Collaborators
University of British Columbia, University of Toronto, University of Melbourne, Boston University, University of California, University of Alberta, Shanghai CDC for Mental Health, Institute of Population Research, Peking University, University of Michigan, Queen's University, Hongkou Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05527951
Brief Title
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
Acronym
EMBED
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
University of British Columbia, University of Toronto, University of Melbourne, Boston University, University of California, University of Alberta, Shanghai CDC for Mental Health, Institute of Population Research, Peking University, University of Michigan, Queen's University, Hongkou Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
measurement-based care, scales, assessment, depression, randomized, cluster trial, implementation, mobile health, WeChat, clinical trial, mixed methods, China

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study protocol involves a 2-arm cluster RCT of enhanced versus standard measurement-based care implementation for depression.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced MBC Implementation(eMBC)
Arm Type
Experimental
Arm 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.
Arm Title
Standard MBC Implementation
Arm Type
Active Comparator
Arm Description
The standard MBC implementation arm use paper and pencil questionnaires.
Intervention Type
Other
Intervention Name(s)
eMBC
Intervention Description
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
Intervention Name(s)
standard MBC
Intervention Description
The control intervention group will implement standard MBC using paper and pencil questionnaires.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
To evaluate the severity of depressive symptoms by patients. Remission: total score ≤ 4.
Time Frame
up to 6 months
Title
Proportion of patients with a Patient Health Questionnaire-9 (PHQ-9) score
Description
Proportion of patients with a PHQ-9 score entered in the clinical record.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9(PHQ-9) change scores
Description
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.
Time Frame
up to 6 months
Title
The Sheehan disability scale (SDS)
Description
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.
Time Frame
up to 6 months
Title
Quality of Life scale (QOL-6)
Description
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
Time Frame
up to 6 months
Title
EuroQoL 5 Dimensions (EQ-5D)
Description
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
Time Frame
up to 6 months
Title
Health economic assessment (HEA)
Description
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.
Time Frame
up to 6 months
Title
Patient Adherence Questionnaire(PAQ)
Description
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.
Time Frame
up to 6 months
Title
Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR-P)
Description
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.
Time Frame
up to 6 months
Title
Proportion of patients who accessed the WeChat Easy to Recover from Depression Mini-Program at least once
Description
Proportion of patients who accessed the WeChat Easy to Recover from Depression Mini-Program at least once.
Time Frame
up to 6 months
Title
Proportion of patients who completed at least 4 of 6 lessons in Come Back mini-program
Description
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.
Time Frame
up to 6 months
Title
System Usability Scale
Description
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.
Time Frame
up to 6 months
Title
Evidence Based Practice Attitude Scale (EBPAS)
Description
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.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Chen, M.D., Ph.D
Phone
021-34773367
Email
doctorcj2010@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xing Wang
Phone
021-34773528
Email
478030003@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Chen, M.D., Ph.D
Organizational Affiliation
Shanghai Mental Health Center(SMHC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Chen, M.D., Ph.D
Phone
021-34773367
Email
doctorcj2010@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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