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

NCT ID: NCT04329702

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2022-03-31

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.

Conditions

Cardiorespiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Coping skills training mobile app with call from CST therapist

Intervention Type: BEHAVIORAL

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 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.

Group Type: EXPERIMENTAL

Coping skills training mobile app only

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Blueprint; mobile coping skills training (mCST) plus therapist; Blueprint; mobile coping skills training (mCST)

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

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

Exclusion Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher E Cox, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28872898 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22527082 (View on PubMed)

Cox CE, Kelleher SA, Parish A, Olsen MK, Bermejo S, Dempsey K, Jaggers J, Hough CL, Moss M, Porter LS. Feasibility of Mobile App-based Coping Skills Training for Cardiorespiratory Failure Survivors: The Blueprint Pilot Randomized Controlled Trial. Ann Am Thorac Soc. 2023 Jun;20(6):861-871. doi: 10.1513/AnnalsATS.202210-890OC.

Reference Type: DERIVED

PMID: 36603136 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34HL145387

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00101848

Identifier Type: -

Identifier Source: org_study_id