Enhancing Delivery of Problem Solving Therapy Using SmartPhone Technology
2016年10月17日 更新者:VA Office of Research and Development
This project will be the first to evaluate the Moving Forward app in VA.
Identifying an effective treatment for anxiety and depression in primary care is imperative within Veterans Health Administration as they are both common, chronic, and debilitating conditions associated with a number of personal and health-related costs.
In close partnership with app developers at Mental Health Services, a major contribution of this research is the actionable feedback on the acceptability, feasibility and effectiveness of augmenting traditional Problem Solving Therapy with the Moving Forward app for future app development.
If effectiveness can be established, Moving Forward has the potential for integration into the larger continuum of care for depression and anxiety in Primary Care-Mental Health Integration (e.g., care management, co-located collaborative care).
Lastly, this pilot project will provide preliminary data for future research on SmartPhone technology.
Veteran feedback on treatment components, ease of executing the study successfully and preliminary effect size calculations, will inform the design of the larger project.
研究概览
详细说明
Access and engagement in evidence-based psychotherapies for Veterans are high priorities for the Veterans Health Administration, especially the Office of Rural Health and the office of Mental Health Services.
SmartPhone applications are an emerging technology with a vast potential to extend the reach of traditional in-person psychotherapy by allowing increased digital access to providers and self-management tools.
Due to the relatively recent development of this technology, there are no data on the effectiveness of SmartPhone-delivered psychotherapy.
Preliminary data on acceptability and satisfaction are promising, suggesting a need for further research.
The National Center for Posttraumatic Stress Disorder in collaboration with the National Center for Telehealth & Technology (T2) recently completed the development of an app called Moving Forward, a Veteran-friendly adaptation of Problem Solving Therapy, an evidence based therapy available through Primary Care Integration Clinics.
In partnership with Mental Health Services, this proposed pilot project will gather preliminary data on the effectiveness and acceptability of Moving Forward and provide timely feedback to the app creators.
Participants will include approximately 40 Veterans diagnosed with an anxiety or mood disorder interested in obtaining mental health treatment in Primary Care -Mental Health Integration.
Participants will be randomly assigned to receive either Problem Solving Therapy augmented by the Moving Forward app or Problem Solving Therapy alone.
Participants will complete assessments at baseline, 6 weeks and 12 weeks.
Investigators propose 3 specific hypotheses.
In hypothesis 1, investigators predict a moderate effect size will be observed when comparing homework completion and satisfaction for patients randomized to Problem Solving Therapy plus the Moving Forward app compared to patients randomized to Problem Solving Therapy alone.
In hypothesis 2, investigators predict a moderate effect size will be observed when comparing change scores on the problem solving style for patients randomized to Problem Solving Therapy plus the Moving Forward app compared to patients randomized to Problem Solving Therapy alone.
In hypothesis 3, investigators predict a moderate effect size will be observed when comparing depression, anxiety, stress and quality of life change for patients randomized to Problem Solving Therapy plus the Moving Forward app compared to patients randomized to Problem Solving Therapy alone.
Key informant interviews will provide qualitative feedback on the Moving Forward app which investigators will share with our partners at Mental Health Services.
The proposed project is important to the VA mission to improve access for all Veterans particularly those who face barriers to engagement in traditional face-to-face treatment.
The proposed research addresses one of three primary focus areas of the Office of Research and Development (Access), two of Health Services Research &Development's research priorities (Access/Rural Health and Mental Health), and three of Secretary Shinseki's Transformational Initiatives for the 21st Century including improving: 1) access to care, 2) mental health, and 3) patient-centeredness.
This proposed work is innovative as it focuses on a rapidly emerging mobile technology that has great potential to improve access and engagement in mental health service delivery.
To date, there have been no randomized effectiveness trials that have examined SmartPhone apps for mental health service delivery.
The project is also timely as there is a temporary moratorium (imposed by the Office of Information Technology) on app dissemination within Veterans Health Administration, presenting an opportunity to study Moving Forward prior to its release.
At the completion of this project, investigators expect that the work proposed in this study will highlight the clinical value of the Moving Forward app, which will inform both VA policy makers and the scientific community at large about the utility of SmartPhone technology in mental health care delivery.
Investigators also expect that this study will provide our partners at Mental Health Services with helpful feedback on the Moving Forward app design and future app development.
研究类型
介入性
注册 (实际的)
33
阶段
- 阶段2
- 阶段1
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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Arkansas
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No. Little Rock、Arkansas、美国、72114-1706
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
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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 64年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Veterans will be eligible if they are 18 years old or older,
- speak and understand English,
- are patients in the Central Arkansas Veterans Healthcare System Primary Care-Mental Health Integration,
and have a current diagnosis of depression
- major depressive disorder, 296.2x and 296.3x
- dysthymic disorder, 300.4
- depressive disorder not otherwise specified, 311
and/or anxiety
- panic disorder without agoraphobia, 300.01
- panic disorder with agoraphobia, 300.21
- specific phobia, 300.29
- social phobia, 300.23
- obsessive-compulsive disorder; 300.3
- posttraumatic stress disorder, 309.81
- acute stress disorder, 308.3
- generalized anxiety disorder, 300.02
- anxiety disorder not otherwise specified, 300.00
- We considered enrolling only those Veterans diagnosed with mild-to-moderate depression, but chose to include a range of anxiety and depression-related disorders in order to reflect the population of Veterans seen in Primary Care-Mental Health Integration.
- Additionally, Problem Solving Therapy is designed to treat a range of stress-related problems, including both anxiety and depressive disorders.
- Veterans taking prescribed anxiolytics or anti-depressants will be eligible if they are on a stable medication regimen.
Exclusion Criteria:
- Exclusionary criteria include any current suicidal ideation,
- substance dependence diagnosis and current use,
- any psychotic spectrum diagnoses or
- inability to provide informed consent.
- Diagnosis will be confirmed by chart review and Mini International Neuropsychiatric Interview.
- Acute suicidal ideation will be determined by the assessing or treating clinician.
- During the baseline and follow-up interviews, any Veteran who endorses a "1" or higher on item # 21 on the Depression Anxiety and Stress Scale "I feel that life isn't worthwhile" or item # 9 on the Patient Health Questionnaire-9 "thoughts that you would be better off dead or of hurting yourself" will be asked follow-up questions on the suicide risk protocol (see appendix 3).
- Current substance or alcohol use will be determined by the alcohol and substance use modules of the Mini International Neuropsychiatric Interview.
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:卫生服务研究
- 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:Problem Solving Therapy plus Moving Forward (PST-MF)
All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999).
Session 1 will take place in-person during a scheduled appointment and will last for 1 hour.
Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from Problem Solving Therapy to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person Problem Solving Therapy or the Moving Forward website.
The phone content matches Problem Solving Therapy.
Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.
|
All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999).
Session 1 will take place in-person during a scheduled appointment and will last for 1 hour.
Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from Problem Solving Therapy to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person Problem Solving Therapy or the Moving Forward website.
The phone content matches Problem Solving Therapy.
Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.
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有源比较器:Problem Solving Therapy
All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999).
Session 1 will take place in-person during a scheduled appointment and will last for 1 hour.
Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
|
All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999).
Session 1 will take place in-person during a scheduled appointment and will last for 1 hour.
Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
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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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Depression Anxiety and Stress Scale (DASS)
大体时间:6 weeks, 12 weeks
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The 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale.
Higher scores represent worse depression symptoms.
The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale.
Higher scores represent worse anxiety symptoms.
The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale.
Higher scores represent worse stress symptoms.
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6 weeks, 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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Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score
大体时间:6 weeks, 12 weeks
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The 12-item Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score is rated on a 0-100 scale.
Higher scores represent better mental health functioning.
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6 weeks, 12 weeks
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Client Satisfaction Questionnaire (CSQ-8)
大体时间:6 weeks
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The 8-item Client Satisfaction Questionnaire (CSQ-8) is rated on an 8-32 scale.
Higher scores represent greater satisfaction with the intervention.
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6 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:Kathleen M Grubbs, PhD、Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
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
2014年4月1日
初级完成 (实际的)
2015年3月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2013年6月25日
首先提交符合 QC 标准的
2013年6月28日
首次发布 (估计)
2013年7月3日
研究记录更新
最后更新发布 (估计)
2016年11月28日
上次提交的符合 QC 标准的更新
2016年10月17日
最后验证
2016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.