Clinical trial NCT04329702: Mobile Coping Skills Training to Improve Cardiorespiratory Failure Survivors' Psychological Distress
Official title: Optimizing a Self-directed Mobile Coping Skills Training Intervention to Improve Cardiorespiratory Failure Survivors' Psychological Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiorespiratory Failure
Keywords: cardiorespiratory failure
critical illness
psychological distress
depression
intensive care units
adults
mechanical ventilation
post-traumatic stress disorder
anxiety
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-04-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: INCLUSION CRITERIA

1. Adult (age ≥18)
2. Managed in a hospital setting for ≥24 hours during the time inclusion criterion #3 is met.
3. 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
4. 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
5. 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
6. Functional English fluency

EXCLUSION CRITERIA (in hospital):

1. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for follow up care, disruptive chemotherapy/radiation regimen)
2. Unable to complete study procedures as determined by staff
3. Lack of access to either reliable smartphone with cellular data plan or wifi

INCLUSION CRITERIA (post-discharge)

1. Elevated baseline (T1) psychological distress symptoms, defined as HADS total score of ≥8

EXCLUSION CRITERIA (post-discharge)

1. Failure to randomize within 2 months post-discharge.
2. Failure to access app within 1 month after randomization in the absence of other explanation (e.g., hospitalization).

Primary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
timeFrame: Between baseline and 1 month post-randomization
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
timeFrame: Between baseline and 3 months post-randomization
measure: Change in Post-Traumatic Stress Symptom Inventory (PTSS)
timeFrame: Between baseline and 1 month post-randomization
measure: Change in Post-Traumatic Stress Symptom Inventory (PTSS)
timeFrame: Between baseline and 3 months post-randomization
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 month post-randomization
measure: Intervention Adherence
timeFrame: 1 month post-randomization
measure: Change in Quality of Life Visual Analog Scale
timeFrame: Between baseline and 1 month post-randomization
measure: Change in Quality of Life Visual Analog Scale
timeFrame: Between baseline and 3 month post-randomization
measure: Patient Health Questionnaire 10-item Scale (PHQ-10)
timeFrame: 1 month post-randomization
measure: Patient Health Questionnaire 10-item Scale (PHQ-10)
timeFrame: 3 months post-randomization
measure: Distress Associated With Depression and Anxiety Symptom Frequency
timeFrame: Between baseline and 1 month post-randomization
measure: Distress Associated With Depression and Anxiety Symptom Frequency
timeFrame: Between baseline and 3 months post-randomization
measure: Distress Associated With PTSD Symptom Frequency
timeFrame: Between baseline and 1 month post-randomization
measure: Distress Associated With PTSD Symptom Frequency
timeFrame: Between baseline and 3 months post-randomization
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Christopher E Cox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox CE, Hough CL, Carson SS, White DB, Kahn JM, Olsen MK, Jones DM, Somers TJ, Kelleher SA, Porter LS. Effects of a Telephone- and Web-based Coping Skills Training Program Compared with an Education Program for Survivors of Critical Illness and Their Family Members. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jan 1;197(1):66-78. doi: 10.1164/rccm.201704-0720OC.
citation: Cox CE, Porter LS, Hough CL, White DB, Kahn JM, Carson SS, Tulsky JA, Keefe FJ. Development and preliminary evaluation of a telephone-based coping skills training intervention for survivors of acute lung injury and their informal caregivers. Intensive Care Med. 2012 Aug;38(8):1289-97. doi: 10.1007/s00134-012-2567-3. Epub 2012 Apr 18.