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

Major Depressive Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527951
• Other study ID #: 2021-77
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Shanghai Mental Health Center
• Contact: Jun Chen, M.D., Ph.D
• Phone: 021-34773367
• Email: doctorcj2010[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (12)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Boston University, Hongkou Mental Health Center, Institute of Population Research, Peking University, Queen's University, Shanghai CDC for Mental Health, University of Alberta, University of British Columbia, University of California, University of Melbourne, University of Michigan, University of Toronto

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9 (PHQ-9)	To evaluate the severity of depressive symptoms by patients. Remission: total score = 4.	up to 6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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