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

Cardiorespiratory Failure Clinical Trial

— Blueprint  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329702
• Other study ID #: Pro00101848
• Secondary ID: 1R34HL145387
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: December 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiorespiratory Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Client Satisfaction Questionnaire (CSQ)	A measure of acceptability. Scores can range from 5 (worst) to 35 (best)	1 month post-randomization
Secondary	Intervention Adherence	Measured by how many total tasks of the 33 possible that participants completed within the app during the intervention. Note that a value >33 indicates that participants completed more tasks than required.	1 month post-randomization
Secondary	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
Secondary	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
Secondary	Patient Health Questionnaire 10-item Scale (PHQ-10)	An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst).	1 month post-randomization
Secondary	Patient Health Questionnaire 10-item Scale (PHQ-10)	An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst).	3 months post-randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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