Digitally Enhanced Stepped-Care for Depression in Primary Care
2026年7月7日 更新者：Jennifer Dahne、Medical University of South Carolina
Digitally Enhanced Stepped-Care for Depression in Primary Care: A Pilot Randomized Clinical Trial to Support Scalable Deployment and Commercialization
This pilot, three-arm randomized clinical trial (N=40; 2:1:1) will evaluate the feasibility and preliminary efficacy of a digitally enhanced stepped-care approach for depression treatment in primary care.
Participants will be randomized to: (1) stepped-care beginning with a self-guided Behavioral Activation app (Moodivate), with stepping to clinician-delivered telebehavioral health Behavioral Activation at Week 2 based on app engagement and early PHQ-9 change; (2) telebehavioral health Behavioral Activation; or (3) Moodivate alone.
The primary endpoint is feasibility of the stepped-care approach, defined as continued engagement after stepping (≥1 Moodivate use/week for >4 weeks or ≥4 therapy sessions).
The secondary endpoint is change in PHQ-9 scores from baseline through Week 12.
The study will be conducted within MUSC Primary Care clinics across South Carolina using remote screening, e-consent, and REDCap assessments.
研究概览
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
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：Noelle Natale
- 电话号码：843-876-9457
- 邮箱：natalen@musc.edu
研究联系人备份
- 姓名：McKay Lucas
- 电话号码：843-876-2611
- 邮箱：lucasmc@musc.edu
学习地点
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South Carolina
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Charleston、South Carolina、美国、29425
- 招聘中
- Medical University of South Carolina
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接触：
- Jennifer Dahne, PhD
- 电话号码：843-876-2280
- 邮箱：dahne@musc.edu
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首席研究员：
- Jennifer Dahne, PhD
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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
是的
描述
Inclusion Criteria:
- elevated depression symptoms (score of >=10 on the PHQ-9)
- age >=18 years
- owns an iOS or Android smartphone
- willing to use Moodivate
- willing to engage in telehealth depression treatment
- access to email or text messaging (for assessments)
- English fluency
Exclusion Criteria:
- current receipt of psychosocial depression treatment (e.g., individual or group therapy)
- current suicidal ideation, defined as a response >=1 ("several days") on PHQ-9 item nine
- does not live in the state of South Carolina
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Digitally-Enhanced Stepped Care
Participants randomized to the Digitally-Enhanced Stepped Care condition will be instructed to utilize a Behavioral Activation therapy focused mobile application called "Moodivate" regularly, at least once per day, for the treatment of depressed mood among cancer survivors.
Participants in the Digitally-Enhanced Stepped Care group will receive a download code to download the Moodivate mobile application.
Moodivate is a mobile app for individuals with elevated symptoms of depression.
Within the app, users identify values, create activities, schedule activities, and rate mood daily.
Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12. App engagement will be passively monitored for two weeks following initial download to determine whether care needs to be stepped up to guideline-concordant standard care.
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Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood.
Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.
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实验性的：Moodivate Only
Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood.
Participants in the Moodivate group will receive a download code to download the Moodivate mobile application.
Moodivate is a mobile app for individuals with elevated symptoms of depression.
Within the app, users identify values, create activities, schedule activities, and rate mood daily.
Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.
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Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood.
Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.
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有源比较器：Telebehavioral Health
Participants randomized to the Telebehavioral Health condition will receive 8 sessions of telehealth-delivered Behavioral Activation therapy with a mental health provider over a 10 week period.
Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 10.
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在10周期间，有8次通过心理健康提供者进行远程医疗行为激活。
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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 |
|---|---|---|
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Feasibility of Digitally Enhanced Stepped-Care
大体时间：12 weeks
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We operationalize feasibility as continued engagement after stepping, defined as either using Moodivate at least once per week for >4 weeks (for engagers) or attending >4 telebehavioral health sessions (for non-engagers).
We selected 4 treatment sessions as meaningful engagement because all BA concepts are introduced to patients within sessions 1-4, and sessions 5-8 primarily reinforce previous concepts.
Because a strength of self-guided DMHIs is highly flexible pacing, we opt to base meaningful DMHI engagement on continued app use over time, for a duration of >4 weeks to be comparable to the BA feasibility benchmark.
Digitally enhanced stepped-care will be considered feasible if >75% of participants meet these feasibility benchmarks.
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change Over Time in Depression Severity
大体时间：12 weeks
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Depression will be assessed via the PHQ-9 at baseline and all follow-ups.
The PHQ-9 has high sensitivity and specificity for identifying depression.
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12 weeks
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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：Jennifer Dahne, PhD、Medical University of South Carolina
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 (实际的)
2026年7月2日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年6月3日
首先提交符合 QC 标准的
2026年6月3日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年7月9日
上次提交的符合 QC 标准的更新
2026年7月7日
最后验证
2026年7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.