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

Not Applicable

Completed

• Conditions: Cardiorespiratory Failure
• Interventions: Behavioral: Coping skills training mobile app only; Behavioral: Coping skills training mobile app with call from CST therapist

• Registration Number: NCT04329702
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Study Start: 2020-12-03
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31
• Results First Submitted: 2022-10-11
• Status Verified: 2022-12
• Results First Submitted QC: 2023-01-24
• Last Update Submitted: 2023-01-24
• Results First Posted: 2023-02-03
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
coping skills training without therapist input	Coping skills training mobile app only	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.
coping skills training plus therapist input	Coping skills training mobile app with call from CST therapist	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.

Primary Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire	Between baseline and 1 month post-randomization	Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)

Secondary Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire	Between baseline and 3 months post-randomization	Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)
Change in Quality of Life Visual Analog Scale	Between baseline and 3 month post-randomization	A measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Distress Associated With Depression and Anxiety Symptom Frequency	Between baseline and 3 months post-randomization	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)
Change in Post-Traumatic Stress Symptom Inventory (PTSS)	Between baseline and 3 months post-randomization	Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).
Intervention Adherence	1 month post-randomization	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.
Client Satisfaction Questionnaire (CSQ)	1 month post-randomization	A measure of acceptability. Scores can range from 5 (worst) to 35 (best)
Patient Health Questionnaire 10-item Scale (PHQ-10)	3 months post-randomization	An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst).
Distress Associated With PTSD Symptom Frequency	Between baseline and 3 months post-randomization	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)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States