Mobile Coping Skills Training to Improve Cardiorespiratory Failure Survivors' Psychological Distress (Blueprint)

Optimizing a Self-directed Mobile Coping Skills Training Intervention to Improve Cardiorespiratory Failure Survivors' Psychological Distress

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.

Study Overview

• Status: Completed
• Conditions: Cardiorespiratory Failure
• Intervention / Treatment: Behavioral: Coping skills training mobile app with call from CST therapist; Behavioral: Coping skills training mobile app only

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 identi-fying 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: coping skills training plus therapist input; Participants will receive a CST therapist call within 48 hours of randomization to discuss the study rationale, to conduct a relaxation exercise, and to review app and study logistics. Participants will use the Blueprint mobile app for 1 month.	Behavioral: Coping skills training mobile app with call from CST therapist; The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. A therapist will call participant to introduce the intervention and perform a brief relaxation exercise.; Other Names: Blueprint; mobile coping skills training (mCST) plus therapist
Experimental: coping skills training without therapist input; Participants will receive a call from a research coordinator to get them started with the trial. Participants will use the Blueprint mobile app for 1 month. No therapist calls will be provided. Chat room access in the app will be provided.	Behavioral: Coping skills training mobile app only; The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. App chat room access will be provided.; Other Names: Blueprint; mobile coping skills training (mCST)
No Intervention: usual care control; Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hospital Anxiety and Depression Scale (HADS) questionnaire	Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)	Between baseline and 1 month post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hospital Anxiety and Depression Scale (HADS) questionnaire	Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)	Between baseline and 3 months post-randomization
Change in Post-Traumatic Stress Symptom inventory (PTSS)	Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).	Between baseline and 1 month post-randomization
Change in Post-Traumatic Stress Symptom inventory (PTSS)	Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).	Between baseline and 3 months post-randomization
Client Satisfaction Questionnaire (CSQ)	A measure of acceptability. Scores can range from 8 (worst) to 32 (best)	1 month post-randomization
Systems Usability Scale (SUS)	A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)	1 month post-randomization
Intervention adherence	Quantified by number of intervention sessions, weekly surveys, and intervention	1 month post-randomization
Change in quality of life visual analog scale	A measure of quality of life. Scores can range from 0 (worst) to 100 (best)	Between baseline and 1 month post-randomization
Change in quality of life visual analog scale	A measure of quality of life. Scores can range from 0 (worst) to 100 (best)	Between baseline and 3 month post-randomization
Change in Patient Health Questionnaire 10-item scale (PHQ-10)	An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).	Between baseline and 1 month post-randomization
Change in Patient Health Questionnaire 10-item scale (PHQ-10)	An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).	Between baseline and 3 months post-randomization
Distress associated with depression and anxiety symptom frequency	A visual analog scale appended to the HADS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the HADS. Scores range from 0 (best) to 100 (worst)	Between baseline and 1 month post-randomization
Distress associated with depression and anxiety symptom frequency	A visual analog scale appended to the HADS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the HADS. Scores range from 0 (best) to 100 (worst)	Between baseline and 3 months post-randomization
Distress associated with PTSD symptom frequency	A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)	Between baseline and 1 month post-randomization
Distress associated with PTSD symptom frequency	A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)	Between baseline and 3 months post-randomization

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Christopher E Cox, MD, Duke University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: mechanical ventilation; depression; anxiety; post-traumatic stress disorder; intensive care units; adults; critical illness; psychological distress; cardiorespiratory failure
• Other Study ID Numbers: Pro00101848; 1R34HL145387 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will follow all NIH guidelines and regulations.
• IPD Sharing Time Frame: We will follow NIH and institutional guidelines.
• IPD Sharing Access Criteria: We will follow NIH and institutional guidelines.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No