Messy Memories: A Mobile Application Exposure Therapy Intervention to Reduce Psychological Distress and Improve Health Behaviors Following Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Percentage of Screened Participants Who Screen Eligible for the Study
研究概览
简要总结
The overall goal of this study is to determine whether English-speaking adults who were discharged from an intensive care unit (ICU) at least one month ago and have some level of distress related to their ICU experience will be interested in, willing to use, and satisfied with a new mobile application (app) designed to help the user process a difficult memory. Participants must have internet access and a smartphone in order to use the app. The goal of the app is to help reduce the psychological distress associated with a memory by processing that memory at one's own pace with app guidance. Participants will be asked to use the app for 6 weeks at least 3 times a week for 30 or more minutes at a time. Participants will also be asked to complete questionnaires over a 12-week period.
The investigators aim to test how possible and realistic it is for people who were hospitalized with a critical illness to voluntarily use this app to process relevant distressing memories of their hospitalization. The investigators hope that these results will inform the design of a larger trial that will be able to test if this app can reduce distress in this patient population, as the app may offer affordable and accessible help for some patients experiencing illness-related distress.
详细描述
Critical illness can be an incredibly traumatic experience, often involving treatment in the intensive care unit (ICU), intubation or other invasive medical procedures, altered levels of consciousness, inability to communicate, sensory and sleep deprivation, physical pain, and delirium. The cumulative physical and psychological stress associated with critical illness can be severe enough to induce clinically-significant symptoms of posttraumatic stress disorder (PTSD). Patients with PTSD symptoms related to prior traumatic medical events are more likely to engage in unhealthy behaviors, such as tobacco use, sedentary lifestyle, poor diet, and medication nonadherence.
Exposure therapy (ET) is considered the gold standard treatment for PTSD and involves repeated exposure to trauma-related stimuli leading to habituation of maladaptive emotional responses and an increased sense of control and self-competence. ET is highly effective for improving PTSD triggered by more typical forms of trauma, such as military combat or sexual assault, but less is known about the role of ET for reducing PTSD symptoms after critical illness.
The goal of this pilot study is to conduct preliminary testing of a newly developed mobile application (Messy Memories) that uses remotely delivered ET to reduce psychological distress and improve health behaviors in survivors of critical illness. The user is asked to audio record a traumatic or distressing memory and process what it feels like to re-experience the memory. Users can return to their recorded memory as often as they like until it becomes easier to re-experience.
The investigators will assess the feasibility and acceptability of recruiting and engaging critical illness survivors in the Messy Memories intervention. They will also explore the efficacy of the intervention for engaging the mechanistic target (PTSD symptoms) to reduce psychological distress. Additional outcomes will include reduction in other psychological symptoms (e.g., depression, anxiety) and improvement in health behaviors (e.g., sleep patterns, physical activity). The results of this study will form the basis of a future adequately powered randomized controlled trial testing whether the Messy Memories intervention can significantly reduce psychological distress and, in turn, improve behavioral outcomes among critical illness survivors.
Aim 1: Assess the feasibility of recruiting and engaging critical illness survivors in a mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: The intervention will be feasible based on recruitment, retention, and completion rates of ≥70%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age 18 years old or older
- •Able to speak and write in English
- •Previously admitted to an ICU
- •Have internet access (e.g., Wi-Fi)
- •Have access to an internet-equipped smartphone device (e.g., iPhone, Android)
- •Meet a minimum threshold of psychological distress related to their prior critical illness as demonstrated by scoring ≥10 points on the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5, see Measures section for a complete description).
排除标准
- •ICU discharge occurred <30 days prior to the time of study enrollment
- •Score <10 points on the PCL-5 during the initial eligibility screening
- •Unable to comply with the protocol (either self-selected or indicating that s/he/they cannot complete all requested tasks) for reasons that include, but are not limited to, cognitive impairment (e.g., dementia), alcohol and/or substance abuse, or severe mental illness (e.g., schizophrenia).
- •Unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as this study may include migrant or mobile patients due to their citizenship and work issues).
结局指标
主要结局
Percentage of Screened Participants Who Screen Eligible for the Study
时间窗: Baseline (pre-intervention)
This is designed to measure the feasibility of study recruitment
Percentage of Eligible Participants Who Enroll in the Study
时间窗: Baseline (pre-intervention)
This is designed to measure the feasibility of study enrollment
Mean Duration of Time Spent Using the Memory Processing Module
时间窗: End of 6-week intervention period
This is designed to measure the feasibility of engaging with the intervention
Percentage of Enrolled Participants Who Record a Memory in the Memory Processing Module
时间窗: End of 6-week intervention period
This is designed to measure the feasibility of engaging with the intervention
Mean Number of Times That the Memory Processing Module is Accessed
时间窗: End of 6-week intervention period
This is designed to measure the feasibility of engaging with the intervention. Of note, this outcome measure reflects the mean number of times per participant that the Memory Processing module was used to record a new memory or replay a previously recorded memory.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility
时间窗: End of 6-week intervention period
Intervention feasibility will be measured with the Feasibility of Intervention Measure (FIM). The FIM is a 4-item questionnaire answered on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). Responses to each item are averaged to obtain an overall score ranging from 1-5, with higher scores indicating a better outcome. Feasibility is defined as a score ≥4.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability
时间窗: End of 6-week intervention period
Intervention acceptability will be measured with the Acceptability of Intervention Measure (AIM). The AIM is a 4-item questionnaire answered on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). Responses to each item are averaged to obtain an overall score ranging from 1-5, with higher scores indicating a better outcome. Acceptability is defined as a score ≥4.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Psychological Distress
时间窗: End of 6-week intervention period
Intervention appropriateness will be measured with the Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire answered on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). Responses to each item are averaged to obtain an overall score ranging from 1-5, with higher scores indicating a better outcome. Appropriateness is defined as a score ≥4.
Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability
时间窗: End of 6-week intervention period
Intervention usability will be measured with the System Usability Scale (SUS). The SUS is a 10-item questionnaire answered on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Scores range from 0-100, with higher scores indicating a better outcome. Usability is defined as a score ≥68.
次要结局
- Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Score(12 weeks)
- Generalized Anxiety Disorder Scale (GAD-7) Score(12 weeks)
- International Physical Activity Questionnaire (IPAQ) Score(12 weeks)
- Number of Hours of Sleep(12 weeks)
- Self-reported Use of Sleep Medication(12 weeks)
- Rating of Sleep Quality(12 weeks)
- Patient Health Questionnaire (PHQ-8) Score(12 weeks)
- Anxiety Sensitivity Index (ASI) Score(12 weeks)
研究者
Nadia A. Liyanage-Don
Assistant Professor of Medicine
Columbia University