Testing a Mindfulness/Acceptance-Based Smartphone App Intervention to Develop Resilience Among Nurses Traumatized From the Effects of the COVID-19 Pandemic: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 主要终点
- Mindfulness (Mindfulness Attention and Awareness Scale or also called MAAS)
研究概览
简要总结
The purpose of the study is to test the feasibility and acceptability of a mindfulness- and acceptance-based smartphone app (MABSA) intervention for frontline nurses emotionally and psychologically impacted by the COVID-19 pandemic. The study will use a randomized controlled trial design of two groups: an intervention group of about 30 participants with posttraumatic stress symptoms and a wait-list control group of about 30 participants. The duration of the MABSA intervention is 6 weeks. The following are the outcomes to be measured: resilience, PTSD, mindfulness, experiential avoidance, and rumination.
详细描述
The objective of the proposed study is to evaluate the feasibility of the Mindfulness/Acceptance-Based Smartphone App (MABSA) intervention in a randomized controlled trial (RCT) environment and to obtain generalized information (i.e., initial efficacy, recruitment, retention, adherence, satisfaction, and usability of the refined intervention). The expected results will provide the foundation for a prospective, fully powered, larger-scale RCT study. The investigator previously developed the MABSA and pilot-tested it in a single-arm study among veterans, and the study will be testing the app among nurses who have been emotionally and psychologically impacted by the COVID-19 pandemic. Our central hypothesis is that the refined MABSA intervention would improve intervention satisfaction, app usability, and adherence and positively affect resilience, PTSD, mindfulness, experiential avoidance, and rumination. The specific aims of the proposed study are outlined below.
AIM 1: To refine the previously developed MABSA intervention. The 6-week smartphone-delivered program will involve (1) daily audio-guided meditations on various mindfulness and acceptance exercises constructed based on the principles of acceptance and commitment therapy; (2) weekly support and feedback through phone calls and/or texting the intervention facilitators; and (3) ecological momentary assessment (daily monitoring of PTSD and resilience) to monitor the progression of treatment response (i.e., the trajectory of resilience and PTSD recovery). The investigator will obtain qualitative feedback on program content and format through a pilot test of the prototype with a group of eligible nurses (N = 4). Upon revising the intervention based on participants' feedback, the investigator will develop the intervention protocol manual for the RCT.
AIM 2: To test the feasibility and acceptability of the refined MABSA intervention in a small-scale RCT for a prospective, fully powered, larger-scale RCT study. The small-scale RCT study will involve the following two groups of frontline nurses: (1) the MABSA intervention group (N = 30) and the wait-list control group (N = 30). Upon collecting the data on recruitment, retention, adherence, intervention satisfaction, and app usability, the study will determine the preliminary efficacy based on the following five outcomes: resilience, PTSD, mindfulness, experiential avoidance, and rumination. Qualitative feedback on the facilitators of and challenges to recruitment, retention, and adherence will be collected via exit interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 18 years old or older, (2) frontline registered nurse or licensed practical nurse practising in the United States, (3) has at least daily access to their own Apple iPhone (version 5 or later) or Android phone, and (4) have posttraumatic stress disorder (PTSD) symptoms (must have a score of 33 or above on the PTSD Checklist for DSM-5)
排除标准
- •(1) Those who have a score of 32 or below on the PTSD Checklist for DSM-5, and (2) healthcare workers that are not RNs or LPNs
结局指标
主要结局
Mindfulness (Mindfulness Attention and Awareness Scale or also called MAAS)
时间窗: The investigator will measure mindfulness (Mindfulness Attention and Awareness Scale, MAAS) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in mindfulness based on the Mindfulness Attention and Awareness Scale (MAAS). There are 15 items in the MAAS. The minimum value of MAAS is 15, and the maximum value is 90. Higher scores mean a better outcome (higher level of mindfulness).
Resilience (Connor-Davidson Resilience Scale or also called CD-RISC-25)
时间窗: The investigator will measure resilience (Connor-Davidson Resilience Scale, CD-RISC-25) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in resilience based on the Connor-Davidson Resilience Scale (CD-RISC-25). There are 25 items in the CD-RISC-25. The minimum value of CD-RISC-25 is 0, and the maximum value is 100. Higher scores mean a better outcome (higher level of resilience).
Posttraumatic Stress Disorder Symptoms (PTSD Checklist for DSM-5 or also called PCL-20)
时间窗: The investigator will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in posttraumatic stress disorder (PTSD) symptoms based on the PTSD Checklist for DSM-5 (PCL-20). There are 20 items in the PCL-20. The minimum value of PCL-20 is 0, and the maximum value is 80. Higher scores mean a worse outcome (more severe symptoms of Posttraumatic Stress Disorder).
Experiential Avoidance (Acceptance and Action Questionnaire or also called AAQ)
时间窗: The investigator will measure experiential avoidance (Acceptance and Action Questionnaire, AAQ) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in experiential avoidance based on the Acceptance and Action Questionnaire (AAQ). There are 7 items in the AAQ. The minimum value of the AAQ is 7, and the maximum value is 49. Higher scores mean a worse outcome (higher level of experiential avoidance or the unwillingness to be present with difficult emotions and thoughts).
Rumination (Rumination Response Scale or also called RRS)
时间窗: The investigator will measure rumination (Rumination Response Scale, RRS) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in rumination based on the Rumination Response Scale (RRS). The RRS has 22 items. The minimum value of the RRS is 22, and the maximum value is 88. Higher scores mean a worse outcome (higher level of rumination or perseverative and passive focus on symptoms and the possible causes and outcomes of psychological distress)
次要结局
- Resilience Progression (Abbreviated Version of the Connor-Davidson Resilience Scale or also called CD-RISC-10)(The investigator will measure resilience daily using the app (ecological momentary assessment))
- Posttraumatic Stress Disorder Recovery (Abbreviated Version of the Posttraumatic Stress Disorder Checklist or also called PCL-8)(The investigator will measure posttraumatic stress disorder symptoms daily using the app (ecological momentary assessment).)
研究者
Andrew Thomas Reyes
Assistant Professor
University of Nevada, Las Vegas