A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of patients prescribed Rejoyn
研究概览
简要总结
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.
详细描述
This study is only recruiting internally from among established patients and does not accept external participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Rejoyn (Device)
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.
干预措施: Cognitive Behavioral Therapy (CBT) exercises (Behavioral)
结局指标
主要结局
Number of patients prescribed Rejoyn
时间窗: From screening through enrollment, approximately 1 week
Number of patients prescribed Rejoyn out of all eligible patients in the clinic
Mean participant app use to assess engagement
时间窗: up to Week 12
Mean number of times app was engaged
Mean duration of app use to assess engagement
时间窗: up to Week 12
Mean duration in minutes of app use
Mean number lessons completed to assess engagement
时间窗: up to Week 12
Mean number lessons completed
Number of participants adherent to Rejoyn
时间窗: up to Week 12
Adherence defined as completion of at least 12 of the 18 sessions
次要结局
- Change in Montgomery Asberg Depression Rating Scale (MADRS) score(baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks)
- Change in Quick Inventory of Depressive Symptomatology (QIDS) score(baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks)
- Mean mHealth Satisfaction Questionnaire score(baseline and 12-weeks)
- Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire(Week 12)