Use of Mobile Apps for Those With PTSD and Their Partners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Symptoms
研究概览
简要总结
In layperson's language state the purpose of the study in 3-5 sentences.
Previous research has demonstrated that intimate partners can positively influence those with PTSD to seek treatment. The investigators have preliminary evidence to demonstrate that mobile apps, such as PTSD Coach can be helpful for those with PTSD, and the current study will provide Veterans with PTSD and their partners with a mobile app designed to promote engagement with evidence-based treatments for PTSD. The purpose of this PILOT study is to evaluate methods for delivering a couples-based intervention to reduce PTSD symptoms and improve relationship quality in Veterans and their intimate partners.
b) State what the Investigator(s) hope to learn from the study. Include an assessment of the importance of this new knowledge.
Understanding ways to improve the public health impact of public-facing, evidence-based mobile apps is critical. This study will test a low-cost, "high-touch" approach to improving the outcomes associated with use of the PTSD Coach and PTSD Family Coach mobile apps,which are already available to the general public and used by over 55,000 new users per year.This study will test whether the involvement of an intimate partner in the use of a mobile app for PTSD will result in changes in how the mobile apps are used and in relationship quality and PTSD symptoms over time. Additionally, this study will test whether the addition of a discussion board can improve engagement with the apps and/or outcomes. The study will also provide useful qualitative data that can inform the development of subsequent dyadic interventions using mobile technologies.
c) Explain why human subjects must be used for this project. (i.e. purpose of study is to test efficacy of investigational device in individuals with specific condition; purpose of study is to examine specific behavioral traits in humans in classroom or other environment)
The purpose of this study is to evaluate how Veterans and their partners interact with evidence-based mobile apps for improving PTSD symptoms.
详细描述
Please SUMMARIZE the research procedures, screening through closeout, which the human subject will undergo. Refer to sections in the protocol attached in section 16, BUT do not copy the clinical protocol. Be clear on what is to be done for research and what is part of standard of care.
In brief, the study team will attempt to recruit 100 couples in which one partner is a community-dwelling Veteran with significant, untreated symptoms of posttraumatic stress disorder (PTSD) symptoms. All participants will receive access to a mobile app designed by Veterans Affairs (VA). Veterans will receive access to the PTSD Coach mobile app, and their partners will receive access to the PTSD Family Coach mobile app. Potential participants will be identified from targeted Facebook and other social media outreach efforts. Those who view an advertisement will be directed to the study website, hosted by Stanford's Qualtrics domain, where they will be provided with information about the study, screened for eligibility,and then provided with an informed consent document. Upon completing the informed consent process, participants will be asked to complete a baseline survey and then to share information about the study with their partner. Veterans and their partners will be connected only by a subject identification number. After completing the baseline survey, all participants will then be encouraged to use the PTSD Coach app or the PTSD Family Coach app as often or as little as they like.
Using random assignment, half of the dyads will also be provided with a) access to a secure, confidential discussion board, where they will be able to post new messages and respond to messages posted by others and b) mailed information packages that contain information about coping with PTSD, coping with a spouse's PTSD, and strategies for managing relationship distress associated with PTSD. Those dyads who do not receive access to the discussion board will still receive access to the mobile apps but will not have access to either the discussion board or the mailed information packages.
Outcomes will be evaluated using objective measures of engagement with the apps, changes in attitudes toward use of mental health services, relationship quality,changes over time in PTSD and stress symptoms, and qualitative experiences associated with use of the apps. Barriers to implementation and identified strategies for overcoming barriers will be catalogued over the duration of the study.
Description of PTSD Coach:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate, participants must be either a Veteran with PTSD or living with a partner who is a Veteran with PTSD.
- •Veterans must be:
- •A veteran of the U.S. Armed Forces
- •Must have a previous diagnosis of PTSD
- •Must have access to a smart phone using the iOS operating system
- •Must not have previously used PTSD Coach.
- •Partners of Veterans must be:
- •An intimate partner of a Veteran
- •Living with that partner
- •Must have access to a smart phone using the iOS operating system
- •must be experiencing significant stress
排除标准
- •a) actual or threatened interpersonal violence in the home
研究组 & 干预措施
App Alone
Both members of the couple will receive a mobile app for PTSD: PTSD Coach for the Veteran and PTSD Family Coach for the partner/spouse.
干预措施: Mobile App for managing stress associated with PTSD (Behavioral)
App + Couples Coach Intervention
Both members of the couple will receive a mobile app for PTSD: PTSD Coach for the Veteran and PTSD Family Coach for the partner/spouse. Those assigned to this arm will also receive mailed materials that are designed to help increase positive communication strategies.
干预措施: Mobile App + Mailed Materials for managing stress associated with PTSD (Behavioral)
App + Couples Coach Intervention
Both members of the couple will receive a mobile app for PTSD: PTSD Coach for the Veteran and PTSD Family Coach for the partner/spouse. Those assigned to this arm will also receive mailed materials that are designed to help increase positive communication strategies.
干预措施: Mobile App for managing stress associated with PTSD (Behavioral)
结局指标
主要结局
Generalized Anxiety Symptoms
时间窗: 10 weeks
Generalized Anxiety Disorder-7 Scale (GAD-7)
Personal Health Questionnaire Depression Scale
时间窗: 10 weeks
8 Item scale measuring depression.
Stress
时间窗: 10 weeks
Perceived Stress Scale
Caregiver Burden
时间窗: 10 weeks
Montgomery Burden Interview
Functional Well-Being
时间窗: 10 weeks
Partner-rated Interpersonal Well-Being Scale
PTSD Symptoms
时间窗: 10 weeks
5 Item Partner-rated Posttraumatic Stress Disorder Checklist-5 (PCL-5)
Positive Relationship Behaviors
时间窗: 10 weeks
Author-constructed relationship behaviors scale
次要结局
- Caregiving Self-Efficacy Scale(10 weeks)
- Relationship Self-Efficacy(10 weeks)
- Positive Partner Communication(10 weeks)
- Emotional Intimacy(10 weeks)
研究者
Jason Owen
Clinical Psychologist
VA Palo Alto Health Care System