Implementation of a Self-Help Depression Program Among Orthopedic Patients
2018年10月10日 更新者：University of Texas at Austin
The proposed study addresses the potential utility of providing an accessible self-help intervention for patients in a medical setting with an estimated diagnosis of MDD.
Specifically, the study will explore whether a) such an intervention can be effectively implemented in a primary care setting and b) patients originally seeking medical attention for an orthopedic problem will be willing to seek psychological treatment and, c) improvement in depression symptoms will lead to improvement in upper and lower extremity functioning.
研究概览
详细说明
The present project will be an open-label trial to assess the feasibility and acceptability of a self-help intervention among a sample of orthopedic patients.
In addition to monitoring the effectiveness of the Deprexis program on depressive symptoms, the proposed project will assess whether a reduction in depressive symptoms will be associated with improvement on patient reported orthopedic impairment.
The investigators will enroll 50 adults and the participants will be given the opportunity to participate in 8 weeks of the web-based online Deprexis program.
研究类型
介入性
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。
学习地点
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Texas
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Austin、Texas、美国、78712
- University of Texas at Austin
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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
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- All patients older than 18 years who present to a surgeon with an upper or lower extremity injury or disability at a participating center (see attached list)
- A level of clinical depression more than minimal symptoms as defined by a score ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9)
- Willing and able to provide informed consent and comply with the protocol
Exclusion Criteria:
- Injury or illness best treated with prompt surgery
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：不适用
- 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 |
|---|---|
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实验性的：Deprexis
Participants will complete 8 weeks of online treatment via a web-based program, Deprexis.
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Participants will complete an 8 week self-help computerized treatments through a web-based online Deprexis program.
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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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Proof of Concept - Acceptability measured by number of eligible participants that choose to participate
大体时间：8 weeks
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The primary outcome will be the level of acceptability of the intervention as measured by the number of eligible participants who chose to participate in the intervention.
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8 weeks
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Proof of Concept - Acceptability measured by number of modules completed on the online program
大体时间：8 Weeks
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The primary outcome will be the level of acceptability of the intervention as measured by number of completed modules on the online Deprexis program.
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8 Weeks
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Proof of Concept - Acceptability measured by qualitative feedback
大体时间：8 Weeks
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The primary outcome will be the level of acceptability of the intervention as measured by qualitative feedback following the intervention created by the investigators on how acceptable the study was for the participant.
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8 Weeks
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Proof of Concept - Feasibility measured by number of eligible participants that choose to participate
大体时间：8 Weeks
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The primary outcome will be the level of feasibility of the intervention as measured by he number of eligible participants who chose to participate in the intervention.
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8 Weeks
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Proof of Concept - Feasibility measured by number of modules completed on the online program
大体时间：8 Weeks
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The primary outcome will be the level of acceptability of the intervention as measured by number of completed modules on the online Deprexis program.
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8 Weeks
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Proof of Concept - Feasibility measured by qualitative feedback
大体时间：8 Weeks
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The primary outcome will be the level of acceptability of the intervention as measured by qualitative feedback following the intervention created by the investigators on how acceptable the study was for the participant.
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8 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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Level of Improvement of Depression (by scores on the PHQ-9)
大体时间：8 weeks
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Secondary outcome measures will be the level of depressive symptoms as evidenced by scores on the PHQ-9.
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8 weeks
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Level of Improvement of Functioning (by scores on the PROMIS Physical Function CAT)
大体时间：8 weeks
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Secondary outcome measure will be the level of improvement in upper and lower extremity function as measured by scores on the PROMIS Physical Function CAT.
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8 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。
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)
2017年4月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2017年8月1日
研究注册日期
首次提交
2017年2月24日
首先提交符合 QC 标准的
2017年3月13日
首次发布 (实际的)
2017年3月20日
研究记录更新
最后更新发布 (实际的)
2018年10月15日
上次提交的符合 QC 标准的更新
2018年10月10日
最后验证
2018年10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.
医学博士的临床试验
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Otsuka Pharmaceutical Development & Commercialization...招聘中
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Yonggui Yuan尚未招聘
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Daniel LindqvistLund University; Ketabon招聘中
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King's College LondonCardiff and Vale University Health Board; South London and Maudsley NHS Foundation Trust; Northamptonshire... 和其他合作者招聘中
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The Second Hospital of Anhui Medical University尚未招聘
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National Science and Technology Council, TaiwanUniversity College Cork; IRCCS Centro San Giovanni di Dio Fatebenefratelli招聘中
Deprexis的临床试验
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Gaia AGKarolinska Institutet; Linkoeping University; University of Bern完全的
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Charite University, Berlin, GermanyKing's College London; Cedars-Sinai Medical Center; Penn State University; NeuroCure Clinical Research... 和其他合作者完全的
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University of LuebeckUniversity of Bern; University of Hamburg-Eppendorf; Björn Meyer, Gaia AG, Hamburg, Germany /...完全的
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University of FribourgUniversity of Bern; Gaia AG; Indian Institute of Technology; Haute école d'Ingénierie et d'Architecture...邀请报名