Online and Mobile Mindfulness Intervention to Reduce Distress
研究概览
详细说明
In brief, 200 community-dwelling veterans with significant, untreated PTSD symptoms will be randomized to one of 2 groups: a no-treatment control group for one month/30-days, followed by receiving the phone app. And a treatment group that will receive the Mobile app or Mindfulness Coach mobile phone app. Potential participants will be identified from targeted Facebook and other social media outreach efforts.
Investigators at Stanford/VAPAHCS will be responsible for recruitment of the Veteran sample. 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. Participants will then be randomized to one of the two groups and provided with an invitation and hyperlink that either a) provides them with information about when they will next be contacted (30-days after initial assessment) (control group), or b) a link that allows them to download the study app (Mindfulness Coach) onto their smart phone. Participants in Group 1 will then be encouraged to use the Mindfulness Coach app as often or as little as they like. Outcomes will be evaluated using objective measures of engagement with the intervention, changes in self-report measures of mindful awareness, attention, and psychological well-being, and qualitative experiences (phone interview) associated with use of each intervention. Barriers to implementation and identified strategies for overcoming barriers will be catalogued over the duration of the study.
Description of Each Condition:
GROUP 1. Mindfulness Coach Mobile App (n = 100). Participants in this condition will complete 3 assessments: initial, end of month two and end of month four. Each participant, following initial assessment will be provided with a link to download the Mindfulness Coach mobile app as well as with brief recommendations for how to use the app over the subsequent 16 weeks of the study. Mindfulness Coach is a mobile app for iPhone and Android, developed by the VA National Center for PTSD in collaboration with National Center for Telehealth and Technology (T2). Mindfulness Coach has been widely downloaded and is the 2nd most popular VA app available to the general public. Mindfulness Coach provides 4 primary treatment components: 1) psychoeducation about PTSD and Mindfulness (e.g., "What is Mindfulness?", "Why Practice Mindfulness?", "Mindfulness for Veterans", "Benefits of Mindfulness for PTSD", "Practice Challenges with PTSD", and "PTSD Symptoms During Practice"), 2) self-monitoring tools for tracking mindfulness practice, 3) 9 audio- guided mindfulness exercises (e.g., "Mindful Breathing", "Body Scan", "Clouds in the Sky", etc.), and 4) reminders to regularly practice mindfulness exercises.
GROUP 2. Will serve, initially, as a No Treatment Control Group (n = 100) for 60- days (one-month). Participants in this condition will initially be provided with links to resources for Veterans with PTSD (http://ptsd.va.gov) and will be told that they will be contacted again in 8 weeks (60 days) to complete a second assessment. Each participant will then be provided with a link to download the Mindfulness Coach mobile app and with brief recommendations for how to use the app over the subsequent 8 weeks of the study (see description above). Participants will participate in a final follow up survey 8 weeks after receiving the app.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Menlo Park、California、美国、94025
- 招聘中
- VA Palo Alto Health Care System Menlo Park Division
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接触：
- Jason Owen, PhD
- 电话号码：23478 650-493-5000
- 邮箱：jason.owen@va.gov
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- PTSD Diagnosis
- Veteran Status
- Must own personal smartphone/tablet with internet connection
- English fluency
Exclusion Criteria:
- Under 18
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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：Mindfulness Coach Mobile App
Participants in this condition will complete 3 assessments: initial, end of month two and end of month four.
Each participant, following initial assessment will be provided with a link to download the Mindfulness Coach mobile app as well as with brief recommendations for how to use the app over the subsequent 16 weeks of the study.
Mindfulness Coach is a mobile app for iPhone and Android, developed by the VA National Center for PTSD in collaboration with National Center for Telehealth and Technology (T2).
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Mindfulness Coach provides 4 primary treatment components: 1) psychoeducation about PTSD and Mindfulness (e.g., "What is Mindfulness?",
"Why Practice Mindfulness?", "Mindfulness for Veterans", "Benefits of Mindfulness for PTSD", "Practice Challenges with PTSD", and "PTSD Symptoms During Practice"), 2) self-monitoring tools for tracking mindfulness practice, 3) 9 audio- guided mindfulness exercises (e.g., "Mindful Breathing", "Body Scan", "Clouds in the Sky", etc.), and 4) reminders to regularly practice mindfulness exercises.
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无干预：No Treatment Control Group
Participants in this condition will initially be provided with links to resources for Veterans with PTSD (http://ptsd.va.gov) and will be told that they will be contacted again in 8 weeks (60 days) to complete a second assessment.
Each participant will then be provided with a link to download the Mindfulness Coach mobile app and with brief recommendations for how to use the app over the subsequent 8 weeks of the study (see description above).
Participants will participate in a final follow up survey 8 weeks after receiving the app.
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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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Mindfulness Questionnaire
大体时间：8 weeks
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This is a 7-item questionnaire which asks participants to rate their ability to practice, and attitude towards mindfulness meditation practices.
Mindfulness meditation in the clinical context is defined as nonjudgmental attention to present-moment experiences.
Originally stemming from Buddhist tradition, it guides users to the regulation of their attention to maintain their focus on immediate experiences such as thoughts, emotions, body posture and sensations, and the ability to approach one's experiences with openness and acceptance.
The minimum score on this scale is 7, maximum 35.
Some items are reverse-coded, and possible responses include "Strongly disagree", "Somewhat disagree", "Neither agree nor disagree", "Somewhat agree", or "Strongly agree".
Higher scores indicate an increased mindfulness practice capability, which is the better outcome.
Responses are summed.
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8 weeks
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PEG Pain Scale
大体时间：8 weeks
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PEG is a 3-item questionnaire assessing Pain Intensity and Interference.
Pain is measured on a 0 to 10 scale by asking participants to rate their pain over the past week.
Responding 0 to any item indicates "No pain", whereas 10 is "Pain as bad as you can imagine".
It also asks how much pain interferes with their enjoyment of life and general activity.
The minimum score is 0, and maximum is 30.
Lower score is the better outcome.
Responses are summed.
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8 weeks
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PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a
大体时间：8 weeks
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PROMIS is an 8-item questionnaire which assesses sleep quality, such as if they feel rested after sleeping, or still feel tired after they wake up, and if that impacts their quality of life.
Some items are reverse-coded, and possible responses include "Not at all", "A little bit", "Somewhat", "Quite a bit", or "Very much".
The minimum score is 8, and the maximum is 40.
Lower score is the better outcome.
Responses are summed.
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8 weeks
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Acceptance and Action Questionnaire (AAQ-II)
大体时间：8 weeks
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AAQ-II is a 10-item questionnaire on how personal memories effect feelings of anxiety and control over one's life.
The Acceptance and Action Questionnaire measures experiential avoidance and psychological inflexibility, such as the avoidance of thoughts and feelings, ability to distinguish negative thoughts from objective facts about the situation, and behavioral adjustment in the presence of difficult thoughts or feelings.
It is used to predict a wide-range of quality of life outcomes (e.g., depression, anxiety, general mental health, job satisfaction, future work absence, and future job performance.
Some items are reverse-coded, and possible responses include "Never true", "Very seldom true", "Seldom true", "Sometimes true", "Frequently true", "Almost always true", or "Always true".
The minimum score is 10, and the maximum is 70.
Lower score is the better outcome.
Responses are summed.
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8 weeks
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PTSD Checklist for DSM-5 (PCL-5)
大体时间：8 weeks
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The PCL-5 is a 20-item questionnaire that assesses the 20 DSM-5 symptoms of PTSD.
The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment, Screening individuals for PTSD, Making a provisional PTSD diagnosis.
Possible responses include "Not at all", "A little bit", "Moderately", "Quite a bit", or "Extremely".
The minimum score is 0, and the maximum is 80. Lower score is the better outcome.
Responses are summed.
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8 weeks
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Patient Health Questionnaire (PHQ-9)
大体时间：8 weeks
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PHQ-9 is a 10-item questionnaire that assesses the DSM-5 symptoms of Major Depression over the past two weeks.
These are operationalized in the amount of impact on respondents daily functioning the symptoms have with possible responses include "Not at all", "Several days", "More than half the days", "Nearly every day".
The minimum score is 0, and the maximum is 36.
Lower score is the better outcome.
Responses are summed.
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8 weeks
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Generalized Anxiety Disorder 7 (GAD-7)
大体时间：8 weeks
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GAD-7 is a 7-item questionnaire that assesses the DSM-5 symptoms of Generalized Anxiety Disorder symptoms over the past two weeks.
These are operationalized in the amount of impact on respondents daily functioning the symptoms have with possible responses include "Not at all", "Several days", "More than half the days", "Nearly every day".
The minimum score is 0, and the maximum is 28.
Lower score is the better outcome.
Responses are summed.
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8 weeks
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The Brief Inventory of Psychosocial Functioning (B-IPF)
大体时间：8 weeks
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B-IPF is a 7-item questionnaire that assesses posttraumatic stress disorder (PTSD)-related psychosocial functional impairment over the past month.
These are operationalized in the amount of difficulty participants have in their social relationships because of their PTSD symptoms.
Possible responses include "0 Not at all", "1", "2", "3 Somewhat", "4", "5", "6 Always", or "N/A".
The minimum score is 0, and the maximum is 42.
Lower score is the better outcome.
Responses are summed.
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8 weeks
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World Health Organization Quality of Life, abbreviated version (WHOQOL) - BREF
大体时间：8 weeks
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WHOQOL - BREF is a 27-item questionnaire that assesses overall quality of life across 4 subscales over the past two weeks.
The first is Physical Health, such as Activities of daily living, Dependence on medicinal substances and medical aids.
Second is Psychological, such as Bodily image and appearance, memory and concentration.
Third is Social relationships, such as Social support and Sexual activity.
And fourth is Environment, such as Financial Resources and Physical safety and security.
These subgroups are analyzed separately and not summed.
Possible responses include "Very dissatisfied", "Dissatisfied", "Neither satisfied nor dissatisfied", "Satisfied", and "Very satisfied" or "Not at all", "A little", "Moderately", "Mostly", "Completely".
Some items are reverse-coded.
The minimum score is 27, and the maximum is 135.
Higher score is the better outcome.
Responses are summed.
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8 weeks
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White Bear Suppression Inventory (WBSI)
大体时间：8 weeks
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WBSI is a 15-item questionnaire that is designed to measure thought suppression. Chronic thoughts suppression is a variable that is related to obsessive thinking and negative affect associated with depression and anxiety. The WBSI can help to identify individuals who are more prone to develop chronic thought suppression as well as individuals who express wishing they were not depressed, but are in fact depressed. Possible responses include "Strongly disagree", "Disagree", "Neutral or don't know", "Agree", and "Strongly agree". The minimum score is 15, and the maximum is 75. Lower score is the better outcome. Responses are summed. |
8 weeks
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Five Facet Mindfulness Questionnaire
大体时间：8 weeks
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Five Facet Mindfulness is a 39-item questionnaire which assesses the participant's awareness of their thoughts, emotions, and physical state at the current moment and in general.
The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
These subgroups can be analyzed separately or summed.
Possible responses include "never or very rarely true", "rarely true", "sometimes true", "often true", or "often true or always true".
Some items are reverse-coded.
The minimum score is 39, and the maximum is 195.
Lower score is the better outcome.
Responses are summed.
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8 weeks
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Multidimensional Assessment of Interoceptive Awareness (MAIA)
大体时间：8 weeks
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Multidimensional Assessment of Interoceptive Awareness is a 32-item questionnaire, of which 17 were selected, which assesses the participant's bodily awareness.
It allows a more differentiated assessment of essential psychological aspects of the perception and evaluation of body sensations.
The four subscales evaluated are Noticing, Not-Distracting, Not-Worrying, and Attention Regulation.
Possible responses include "0 Never", "1", "2", "3", "4" or "5 Always".
Higher total scores and subscale scores indicate higher levels of positive awareness, the better outcome.
The minimum score is 0, and the maximum is 85.
Some items are reverse coded, and subscales are averaged separately, then summed.
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8 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 35540
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