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

NCT04329702 | Completed Results DMC

• 2 other identifiers: Pro001018481R34HL145387
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiorespiratory Failure

Keywords

cardiorespiratory failure; critical illness; psychological distress; depression; intensive care units; adults; mechanical ventilation; post-traumatic stress disorder; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire

  Between baseline and 3 months post-randomization

• Change in Post-Traumatic Stress Symptom Inventory (PTSS)

  Between baseline and 1 month post-randomization

• Change in Post-Traumatic Stress Symptom Inventory (PTSS)

  Between baseline and 3 months post-randomization

• Client Satisfaction Questionnaire (CSQ)

  1 month post-randomization

• Intervention Adherence

  1 month post-randomization

Study Arms (3)

coping skills training plus therapist input

EXPERIMENTAL

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

coping skills training without therapist input

EXPERIMENTAL

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

usual care control

NO INTERVENTION

Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.

Interventions

Coping skills training mobile app with call from CST therapist 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.

Also known as: Blueprint; mobile coping skills training (mCST) plus therapist

coping skills training plus therapist input

Coping skills training mobile app only 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.

Also known as: Blueprint; mobile coping skills training (mCST)

coping skills training without therapist input

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age ≥18)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• 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.

  PMID: 28872898 BACKGROUND

• 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.

  PMID: 22527082 BACKGROUND

• 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.

  PMID: 36603136 DERIVED

MeSH Terms

Conditions

Critical Illness; Depression; Stress Disorders, Post-Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Christopher Cox
• Organization: Duke University

christopher.cox@duke.edu

9196817232

Study Officials

• Christopher E Cox, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PI and analysts blinded to allocation. Outcomes completed by participants via a mobile app and as such, outcomes assessors are blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized control clinical trial

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: December 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We will follow NIH and institutional guidelines.
• Access Criteria: We will follow NIH and institutional guidelines.

Locations

US (1)