A Trial of Enhanced Versus Standard Measurement-Based Care Implementation for Depression

NCT ID: NCT05577494

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2023-12-31

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. This study intends to compare differences of efficacy between the implementation with eMBC using WeChat and the standard MBC implementation using paper-pencil assessments at the clinic, for both implementation and clinical outcomes.

Detailed Description

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. Therefore, we 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. The primary implementation outcome is implementation reach, defined as the proportion of eligible patients with a PHQ-9 score recorded in the hospital chart at 6 months after MBC implementation. The primary clinical outcome is clinical remission, defined as a PHQ-9 score of 4 or less at the 6-month follow up. Other implementation and clinical outcomes will be examined, including medication adherence, doctor-patient alliance, and a piggy-back cost-benefit economic analysis. Qualitative interviews will be conducted with physicians and patients to produce an interpretive account of the contextual factors which impact eMBC implementation. This study intends to compare differences of efficacy between the implementation with eMBC using WeChat and the standard MBC implementation using paper-pencil assessments at the clinic, for both implementation and clinical outcomes.

Conditions

Major Depressive Disorder; Mobile Health

Keywords

major depressive disorder; measurement-based care; mobile health

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Clinicians

Three hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 100 clinicians are recruited in total. Then, they will receive an online questionnaire and complete the Clinician Questionnaire. Finally, the survey results need to be qualitatively analyzed.

Questionnaire online

Intervention Type: OTHER

Questionnaire online: all subjects will receive an online questionnaire and complete the Clinician Questionnaire.

Semi-structured interviews: semi-structured interviews are conducted with the clinician interviewers using the Clinician Interview Guide.

Focus group discussion: Focus group discussions are conducted with patients according to the Patient Focus Group Symposium Manual.

Clinician interviewers

Three hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 30 clinicians are recruited in total (10 in each clinical institution). Each clinical institution shall select 2-3 interviewers, who shall participate in interview consistency training. Semi-structured interviews are conducted with the enrolled clinicians using the Clinician Interview Guide. The interview process needs to be recorded, and the interview results need to be qualitatively analyzed.

No interventions assigned to this group

Outpatients with MDD:

Three hospitals in Shanghai are included: Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Tongji Hospital of Tongji university, and 600 patients with MDD are recruited in outpatient clinics (200 in each institution). The patient questionnaire will be completed online. The enrolled patients need to conduct an online questionnaire survey and complete the Patient Questionnaire. Finally, the survey results need to be qualitatively analyzed.

Questionnaire online

Intervention Type: OTHER

Questionnaire online: all subjects will receive an online questionnaire and complete the Clinician Questionnaire.

Semi-structured interviews: semi-structured interviews are conducted with the clinician interviewers using the Clinician Interview Guide.

Focus group discussion: Focus group discussions are conducted with patients according to the Patient Focus Group Symposium Manual.

Patients with MDD receiving focus group discussion

Each center will hold 1-2 focus group symposiums for 8-10 patients according to the Patient Focus Group Symposium Manual. The content of the symposium needs to be recorded and written. Finally, the interview results need to be qualitatively analyzed.

No interventions assigned to this group

Interventions

Questionnaire online

Questionnaire online: all subjects will receive an online questionnaire and complete the Clinician Questionnaire.

Semi-structured interviews: semi-structured interviews are conducted with the clinician interviewers using the Clinician Interview Guide.

Focus group discussion: Focus group discussions are conducted with patients according to the Patient Focus Group Symposium Manual.

Intervention Type: OTHER

Other Intervention Names

Semi-structured interviews; Focus group discussion

Eligibility Criteria

Inclusion Criteria

• Recruited clinicians who are on the job and they come from Shanghai Mental Health Center, the Children's Hospital of Fudan University, and Shanghai Tongji Hospital
• Recruited clinicians are of different ages, working years and genders;
• Recruited clinicians understand the research content and sign the informed consent form

• Recruited patients should be definitely diagnosed as "MDD" in their outpatient records, and those patients are in a stable state of illness and can cooperate in completing the questionnaire survey or accepting the focus group discussion;
• Recruited patients have junior high school education or above, as well as adequate audio-visual skills, and can fully understand the informed consent form and interview content.
• The age of the recruited patients is 12-65 years, and the number of children and adolescents aged 12-18 years is not less than one third of the total sample size of patients;
• The enrolled patients or the guardian of them can understand the research content and sign the informed consent form.

Exclusion Criteria

• Recruited clinicians are unable to conduct effective verbal conversation;
• Recruited clinicians are unable to cooperate or complete other situations of the interview.

• Recruited patients who have obvious violent attacks or tendencies;
• Recruited patients who are in the attack or unstable period of illness;
• There is a serious tendency to commit suicide;
• Recruited patients who are unable to conduct effective verbal conversation;
• Recruited patients who cannot cooperate or complete other situation of the interview.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Chen

Role: STUDY_CHAIR

Shanghai Mental Health Center

Jinhua Sun

Role: STUDY_CHAIR

The Children's Hospital of Fudan University

Qingwei Li

Role: STUDY_CHAIR

Tongji Hospital

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Chen

Role: CONTACT

Phone: 021-34773011

Email: doctorcj2010@gmail.com

Facility Contacts

Jun Chen, M.D., Ph.D

Role: primary

Other Identifiers

SHDC120120126

Identifier Type: -

Identifier Source: org_study_id