Augmented Depression Therapy (ADepT) Case Series
2026年7月28日 更新者：Jay Fournier、Ohio State University
This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care.
ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly.
As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.
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：Jay Fournier, Ph.D.
- 电话号码：614-814-6485
- 邮箱：Jay.Fournier@osumc.edu
学习地点
-
-
Ohio
-
Columbus、Ohio、美国、43214
- The Ohio State University Wexner Medical Center
-
接触：
- Jay Fournier, PhD
- 电话号码：614-814-6485
- 邮箱：jay.fournier@osumc.edu
-
-
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
描述
Inclusion Criteria:
- Aged 18 -65
- Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First & Williams, 2021)
- Scoring > 10 on the PHQ-9
- Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.
Exclusion Criteria:
- Diagnosis of a psychotic or bipolar disorder
- History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
- Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
- Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
- Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers/treatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible.
- Presence of another psychiatric disorder judged to be primary
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：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：3 week baseline + ADepT
Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
实验性的：4 week baseline + ADepT
Baseline assessments will be made weekly for 4 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
实验性的：5 week baseline + ADepT
Baseline assessments will be made weekly for 5 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
实验性的：6 week baseline + ADepT
Baseline assessments will be made weekly for 6 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
实验性的：7 week baseline + ADepT
Baseline assessments will be made weekly for 7 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
实验性的：8 week baseline + ADepT
Baseline assessments will be made weekly for 8 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
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 |
|---|---|---|
|
Acceptability
大体时间：From enrollment to the end of treatment at 82 weeks
|
Patient ratings of treatment acceptability
|
From enrollment to the end of treatment at 82 weeks
|
|
Attrition
大体时间：From enrollment to the end of treatment at 82 weeks.
|
Patient attendance records
|
From enrollment to the end of treatment at 82 weeks.
|
|
Adverse Events
大体时间：From enrollment to the end of treatment at 82 weeks.
|
Self-reported adverse events
|
From enrollment to the end of treatment at 82 weeks.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
大体时间：From enrollment to the end of treatment at 82 weeks.
|
The MADRS is a clinician-administered, 10-item assessment tool used to measure the severity of depressive symptoms and monitor changes in depression over time.
Min=0, Max=60, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Patient Health Questionnaire - 9 Item Version (PHQ-9)
大体时间：From enrollment to the end of treatment at 82 weeks.
|
The PHQ-9 is a 9-item self-report measure of depression severity.
Min=0, Max=27, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
大体时间：From enrollment to the end of treatment at 82 weeks.
|
The WEMWBS is a 14-item self-report questionnaire designed to measure positive mental wellbeing, including emotional, psychological, and social functioning.
Min=14, Max=70, higher scores indicate higher levels of wellbeing.
|
From enrollment to the end of treatment at 82 weeks.
|
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。
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8月1日
初级完成 (估计的)
2028年8月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年7月23日
首先提交符合 QC 标准的
2026年7月28日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Only IRB approved personnel will have access to identifiable data.
De-identified data may be shared with other research groups examining similar questions or as a requirement for publication in certain journals.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.