Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study:A Cluster Randomized Controlled Trial of Enhanced Versus Standard Measurement-Based Care Implementation for Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: up to 6 months
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
时间窗: up to 6 months
Proportion of patients with a PHQ-9 score entered in the clinical record.
次要结局
- Quality of Life scale (QOL-6)(up to 6 months)
- EuroQoL 5 Dimensions (EQ-5D)(up to 6 months)
- Patient Health Questionnaire-9(PHQ-9) change scores(up to 6 months)
- Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR-P)(up to 6 months)
- The Sheehan disability scale (SDS)(up to 6 months)
- Proportion of patients who accessed the WeChat Easy to Recover from Depression Mini-Program at least once(up to 6 months)
- System Usability Scale(up to 6 months)
- Health economic assessment (HEA)(up to 6 months)
- Patient Adherence Questionnaire(PAQ)(up to 6 months)
- Proportion of patients who completed at least 4 of 6 lessons in Come Back mini-program(up to 6 months)
- Evidence Based Practice Attitude Scale (EBPAS)(up to 6 months)