REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness (REWIRE)
2026年9月4日 更新者：Yale University
A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder
Rejoyn is a Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD).
This study aims to evaluate the feasibility, engagement, and clinical context of integrating Rejoyn into standard interventional workflows at the Yale New Haven Hospital Interventional Psychiatry Service (IPS).
This is a non-significant risk, observational real-world evidence (RWE) study.
研究概览
详细说明
This study is only recruiting internally from among established patients and does not accept external participants.
研究类型
观察性的
注册 (估计的)
50
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Morgan Hardy, MD, MPH
- 电话号码：(203)764-9131
- 邮箱：rewire.study@yale.edu
学习地点
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Connecticut
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Greenwich、Connecticut、美国、06830
- Yale Greenwich Hospital Interventional Psychiatry Services
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New Haven、Connecticut、美国、06519
- Yale New Haven Hospital Interventional Psychiatry Services
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adults diagnosed with MDD who are receiving intranasal esketamine or TMS.
描述
Inclusion Criteria:
- Clinician-confirmed diagnosis of Major Depressive Disorder
- Currently being treated with an antidepressant medication
- Currently receiving or initiating TMS or esketamine at YNHH IPS
- For those receiving TMS, they must be able to initiate Rejoyn within the first two weeks of beginning TMS
- Experiencing at least mild depressive symptoms as defined by QIDS of ≥6
- Clinician determines patient is appropriate for Rejoyn and prescribes it as part of standard care
- Able to access and use a compatible smartphone
- Able to provide informed consent for use of clinical data in research
Exclusion Criteria:
- Clinician determines Rejoyn is not suitable or safe for the patient
- Significant cognitive impairment that prevents app use
- Insufficient English proficiency to use Rejoyn
- Concurrent participation in another interventional study that would interfere with naturalistic data
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Rejoyn in participants with Major Depressive Disorder
Rejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment.
The Rejoyn program includes 6 weeks of active Emotional Faces Memory Task (EFMT) training and Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review.
|
Rejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment.
Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of patients prescribed Rejoyn
大体时间：From screening through enrollment, approximately 1 week
|
Number of patients prescribed Rejoyn out of all eligible patients in the clinic
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From screening through enrollment, approximately 1 week
|
|
Mean participant app use to assess engagement
大体时间：up to Week 12
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Mean number of times app was engaged
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up to Week 12
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Mean duration of app use to assess engagement
大体时间：up to Week 12
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Mean duration in minutes of app use
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up to Week 12
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Mean number lessons completed to assess engagement
大体时间：up to Week 12
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Mean number lessons completed
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up to Week 12
|
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Number of participants adherent to Rejoyn
大体时间：up to Week 12
|
Adherence defined as completion of at least 12 of the 18 sessions
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up to Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS) score
大体时间：baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
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A 10-item rating scale assessing symptoms of depression.
The score ranges from 0 (no depression) to 60 (very depressed).
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baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
|
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Change in Quick Inventory of Depressive Symptomatology (QIDS) score
大体时间：baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
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A 16-item self-reported rating scale designed to assess severity of depressive symptoms.
Scores range from 0 to 27, with higher scores indicating greater depression.
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baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
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Mean mHealth Satisfaction Questionnaire score
大体时间：baseline and 12-weeks
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Satisfaction Questionnaire to assess participant satisfaction.
Scores range from 1 to 5, with higher scores indicating more satisfaction.
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baseline and 12-weeks
|
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Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire
大体时间：Week 12
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Number of clinicians who referred patients to Rejoyn that complete the Clinician Feasibility & Workflow Questionnaire at the end of the study
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Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Morgan Hardy, MD, MPH、Yale University
- 首席研究员：Songjun W Li, MD PhD、Yale University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年8月20日
首先提交符合 QC 标准的
2026年8月24日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月4日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.