Optimizing a Self-directed Mobile Coping Skills Training Intervention to Improve Cardiorespiratory Failure Survivors' Psychological Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
研究概览
简要总结
This is a pilot randomized clinical trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is designed to test the acceptability, feasibility, and clinical impact of a coping skills training intervention (Blueprint) delivered via a mobile app. This trial will allow us to determine if new changes to intervention delivery, inclusion criteria, and other factors are successful. It will also inform the development of a next-step efficacy focused trial.
详细描述
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), research has clarified how these survivors suffer from severe and persistent symptoms of psychological distress-depression, anxiety, and post-traumatic stress disorder (PTSD)-after discharge. However, few interventions exist that are relevant to patients' experiences and that also accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, we developed a telephone- and web-based coping skills training (CST) program.
CST is an empirically-supported psychosocial intervention that targets the use of the adaptive coping skills to decrease psychological distress and improve quality of life. We conducted a multicenter randomized clinical trial (RCT) called CSTEP that compared CST to an education program (EP) among a general sample of ICU survivors who received mechanical ventilation for cardiorespiratory failure. CST reduced depression symptoms and improved quality of life at 6 months in a pre-specified subgroup with elevated baseline distress. This RCT also identified key questions regarding best practices for identifying patients who are highly distressed yet whose physical illness is manageable, as well as delivering the intervention in a more convenient, and scalable manner. In a recent RCT testing a mindfulness intervention (LIFT), we found that a self-directed mobile app approach increased dose, adherence, and retention. However, many patients reported low enthusiasm for a meditation-based intervention.
What is needed before a second multicenter RCT is to apply the promising CST content to a LIFT-inspired mobile app-based delivery system, and then to test it within a targeted patient population with a high likelihood of response (i.e., high baseline psychological distress). Therefore, we propose a 2-year R34 mixed-methods project that includes a pilot RCT in which we will randomize 45 cardiorespiratory failure / insufficiency survivors to one of three arms in equal ratios: intervention plus therapist for non-responders (n ~15), intervention without a therapist (n ~15), and usual care control (n ~15). Randomization will be stratified by ICU service (medical vs. surgical), baseline HADS score (<14 vs. ≥14), and age (<50 vs. ≥50). Our specific aims will: (1) Optimize the usability of a self-directed mobile app (Blueprint) and an automated post-discharge distress screening system; (2) Test two promising iterations of Blueprint vs. usual care in a pilot 3-arm RCT with 3-month follow up, and (3) Explore facilitators and barriers to Blueprint implementation, using these data to inform any necessary final revisions to the Blueprint app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
PI and analysts blinded to allocation. Outcomes completed by participants via a mobile app and as such, outcomes assessors are blinded.
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
- •Adult (age ≥18)
- •Managed in a hospital setting for ≥24 hours during the time inclusion criterion #3 is met.
- •Acute cardiorespiratory failure / insufficiency, defined as ≥1 of the following:
- •mechanical ventilation via endotracheal tube for ≥4 hours
- •non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure
- •new use of supplemental oxygen ≥2 liters per minute (or increase in baseline continuous oxygen)
- •use of vasopressors for shock of any etiology
- •use of inotropes for shock of any etiology
- •use of pulmonary vasodilators
- •use of aortic balloon pump or cardiac assist device for cardiogenic shock
- •use of diuretic intravenous drip
- •Cognitive status intact
- •No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
- •Absence of current significant cognitive impairment (impairment defined as ≥3 errors on the Callahan cognitive status screen)
- •Decisional capacity present
- •Absence of severe and/or persistent mental illness
- •Treatment for severe and/or persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia [as per medical record], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission
- •No endorsement of active suicidality at time of admission or informed consent
- •No active substance abuse at a severity that impairs ability to participate
- •Functional English fluency
排除标准
- •(in hospital):
- •Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for follow up care, disruptive chemotherapy/radiation regimen)
- •Unable to complete study procedures as determined by staff
- •Lack of access to either reliable smartphone with cellular data plan or wifi
- •INCLUSION CRITERIA (post-discharge)
- •Elevated baseline (T1) psychological distress symptoms, defined as HADS total score of ≥8
- •EXCLUSION CRITERIA (post-discharge)
- •Failure to randomize within 2 months post-discharge.
- •Failure to access app within 1 month after randomization in the absence of other explanation (e.g., hospitalization).
结局指标
主要结局
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
时间窗: Between baseline and 1 month post-randomization
Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)
次要结局
- Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire(Between baseline and 3 months post-randomization)
- Change in Quality of Life Visual Analog Scale(Between baseline and 3 month post-randomization)
- Distress Associated With Depression and Anxiety Symptom Frequency(Between baseline and 3 months post-randomization)
- Change in Post-Traumatic Stress Symptom Inventory (PTSS)(Between baseline and 3 months post-randomization)
- Intervention Adherence(1 month post-randomization)
- Client Satisfaction Questionnaire (CSQ)(1 month post-randomization)
- Patient Health Questionnaire 10-item Scale (PHQ-10)(3 months post-randomization)
- Distress Associated With PTSD Symptom Frequency(Between baseline and 3 months post-randomization)