Adapting Project UPLIFT for Hispanic Patients With Epilepsy II
2020年5月19日 更新者：NYU Langone Health
Adapting Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is for Hispanic Patients With Epilepsy II
The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression.
Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL); it was developed at Emory University with CDC funding.
The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression.
Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL); it was developed at Emory University with CDC funding.
研究概览
详细说明
The goal of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. A 2-arm randomized control trial will be conducted to evaluate the feasibility, acceptability and effects of Project UPLIFT versus usual care (UC) in Hispanic patients with epilepsy.
The specific aim of this study is: To evaluate the feasibility, acceptability and short- and long-term effects of the adapted intervention on depression and other outcomes in 72 English- and Spanish-speaking Hispanic epilepsy patients.
研究类型
介入性
注册 (实际的)
72
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
-
-
New York
-
New York、New York、美国、10016
- New York University School of Medicine
-
-
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
21年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- self-identified as Hispanic
- English or Spanish speaking
- diagnosis of epilepsy for at least one year post diagnosis
- willing to participate in 8 one-hour telephone sessions every week for eight weeks.
- willing to be audio-taped
- Elevated depressive symptoms (Center for Epidemiological Studies Depression Scale (CES-D) score >13
Exclusion Criteria:
- Severe depression (CES-D > 37)
- Active suicidal ideation
- Significant cognitive impairment (evident during screening)
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：UPLIFT
Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL).
|
Description of the UPLIFT program: Participants who choose to participate in UPLIFT will complete 8 weekly group sessions via telephone. Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping & Relaxing Session 4: Attention & Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure & the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks |
|
有源比较器：USUAL CARE
Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
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Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
|
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 |
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
大体时间：12 Months
|
This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.
|
12 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality Of Life in Epilepsy (QOLIE-10)
大体时间：12 Months
|
This measure assesses health-related quality of life for adults with epilepsy.
|
12 Months
|
|
PROMIS-Global
大体时间：12 Months
|
This 10-item measure was developed by NIH to assess physical, mental and social functioning.
It is a generic rather than disease-specific measure of global health.
|
12 Months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire (WPAI)
大体时间：12 Months
|
This self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.
|
12 Months
|
|
Self-Compassion Scale (SCS)
大体时间：12 Months
|
This measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.
|
12 Months
|
|
Satisfaction with Life Scale (SWLS)
大体时间：12 Months
|
This 5-item instrument measures global cognitive judgments of satisfaction with one's life.
|
12 Months
|
|
Interpersonal Support Evaluation List (ISEL)
大体时间：12 Months
|
This measure assesses the perceived availability of appraisal, belonging and tangible social support.
|
12 Months
|
|
Five Facet Mindfulness Questionnaire Description (FFMQ) Short form
大体时间：12 Months
|
This 24-item measure assesses the construct of mindfulness through five component skills: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
|
12 Months
|
|
Ruminative Responses Scale (RRS)
大体时间：12 Months
|
This 22-item scale assesses cognitive responses to depressed mood.
|
12 Months
|
|
Perceived Stress Scale (PSS-10)
大体时间：12 Months
|
This 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.
|
12 Months
|
|
Pittsburgh Sleep Quality Index (PSQI)
大体时间：12 Months
|
This 19-item questionnaire assesses sleep quality over the past month.
|
12 Months
|
|
Epilepsy Stigma Scale
大体时间：12 Months
|
This 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.
|
12 Months
|
|
Healthcare Utilization
大体时间：12 Months
|
This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).
|
12 Months
|
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：Tanya Spruill、NYU Langone Health
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)
2016年10月1日
初级完成 (实际的)
2019年9月1日
研究完成 (实际的)
2019年9月1日
研究注册日期
首次提交
2016年12月20日
首先提交符合 QC 标准的
2016年12月20日
首次发布 (估计)
2016年12月22日
研究记录更新
最后更新发布 (实际的)
2020年5月21日
上次提交的符合 QC 标准的更新
2020年5月19日
最后验证
2020年5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.