Smartphone Delivery of Cognitive Behavioral Therapy for Post-intensive Care Syndrome-Family: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in depression-Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Family members of critically ill (ICU) patients are at risk for developing significant symptoms of anxiety, depression, and post-traumatic stress during and after the ICU experience. Cognitive behavioral therapy is a form of therapy that can help individuals cope with stressful events in a more active and effective way. This study will examine the effectiveness of a smartphone self-care app delivering cognitive behavioral therapy in decreasing the psychological symptoms suffered by ICU family members. Half of the sample will receive the self-care app and half of the study sample will receive the usual supportive care given to family members of ICU patients. The researchers anticipate the self-care app will diminish the severity of anxiety, depression, and post-traumatic stress symptoms experienced by ICU family members.
详细描述
Family members of critically ill patients suffer symptoms of post-intensive care syndrome-family (PICS-F), including anxiety, depression, and post-traumatic stress disorder with a diminished quality of life. These symptoms persist long after the episode of critical illness and can linger for years. Cognitive behavioral therapy has become the primary non-pharmacological treatment of an increasing list of psychological symptoms and disorders, including anxiety, depression, and post-traumatic stress. For mild-to-moderate symptoms, mobile technology delivery of cognitive behavioral therapy without input from a clinician has been found to be feasible and well-accepted with efficacy that rivals face-to-face therapy.
The purpose of this pilot study is to examine the efficacy of smartphone delivery of cognitive behavioral therapy via a mobile health app (intervention) on the severity and prevalence of PICS-F symptoms in family members of critically ill patients. The study will include family members of critically ill patients admitted to two 26-bed ICUs at the Akron campus of Summa Health System. A prospective, repeated measures, longitudinal design with randomization to two groups (control, intervention) will be employed. Primary outcome measures will include symptoms of PICS-F (anxiety, depression, post-traumatic stress), health-related quality of life, and mental health self-efficacy measured at enrollment, 30 days after enrollment, and 60 days after enrollment. App usage over the course of the study (number of logins, total time spent with app) will be obtained at the final time point of the study (60 days after enrollment). A sample size of 60 family members is planned for this pilot study (30 intervention, 30 control). The sample size was determined according to the recommendations of Whitehead et al.estimating an a priori small effect size and an attrition rate of 30% derived from previous studies.
The aims of the study are:
Aim 1: Determine the prevalence and severity of PICS-F symptoms (anxiety, depression, post-traumatic stress), health-related quality of life (HRQOL), and mental health self-efficacy (MHSE) in family decision makers of critically ill patients and their change over time (enrollment, 30 days, 60 days).
Aim 2: Determine differences in PICS-F symptom severity, HRQOL, and MHSE in family decision makers of critically ill patients receiving a mobile health app (MHapp) intervention compared to family members receiving standard care and support.
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
- •18 years of age or older
- •self-identifies as the family decision-maker of the critically ill patient
- •reads and speaks English
- •owns a smartphone with iOS or Android operating system
- •critically ill family member has been in the ICU greater than three days
- •critically ill family member is mechanically ventilated and lacks cognitive capacity
- •critically ill family member is not expected to be transferred out of the ICU within the next 48 hours
- •critically ill family member is 18 years of age or older.
排除标准
- •Employee of Summa Health System
研究组 & 干预措施
App Intervention
Participants will download a mobile self-care app on their smartphones. The app guides users through exercises based on cognitive behavioral therapy principles. Participants will be able to use the app as frequently as desired throughout the course of the study.
干预措施: App Intervention (Behavioral)
Control
Participants will receive usual supportive care provided to family members of ICU patients.
结局指标
主要结局
Change in depression-Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline, 30 days, 60 days
The HADS is a 14-item scale with seven items forming an anxiety subscale (HADS-A) and seven items forming a depression subscale (HADS-D). Each of the two subscales can have scores ranging from 0-21 with higher scores indicating higher levels of anxiety or depression symptoms.
Change in health-related quality of life measured by Medical Outcomes Study 12-item Short-Form General Health Survey (SF- 12)
时间窗: Baseline, 60 days
The SF-12 is a 12-item self-report scale measuring health-related quality of life. Each item on the scale is scored using a Likert-type scale with raw scores transformed to a 0 (worst) to 100 (best) scale. The scale provides a summary score of 0 to 100 for physical and mental quality of life with higher scores representing a more positive quality of life.
Change in Mental Health Self-Efficacy Scale (MHSES) score
时间窗: Baseline, 30 days, 60 days
The MHSES is a 6-item scale measuring mental health self-efficacy. Each item is measured on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). Items are summed for a total score ranging from 6-60 with higher scores indicating higher levels of mental health self-efficacy.
Change in anxiety-Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline, 30 days, 60 days
The HADS is a 14-item self-report scale with seven items forming an anxiety subscale (HADS-A) and seven items forming a depression subscale (HADS-D). Each of the two subscales can have scores ranging from 0-21 with higher scores indicating higher levels of anxiety or depression symptoms.
Change in post-traumatic stress measured by the PTSD Checklist for DSM-5 (PCL-5)
时间窗: Baseline, 30 days, 60 days
The PCL-5 is a 20-item self-report measure corresponding to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for PTSD. A total symptom severity score (0-80) can be obtained by summing all of the items with higher scores indicating higher severity of PTSD symptoms.
次要结局
- App usage(From enrollment to study completion (60 days))
研究者
Amy Petrinec
Assistant Professor
Kent State University