Ignite Creation Date:
2024-05-06 @ 2:28 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04329702
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2020-03-30
Brief Title:
Mobile Coping Skills Training to Improve Cardiorespiratory Failure Survivors Psychological Distress
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Optimizing a Self-directed Mobile Coping Skills Training Intervention to Improve Cardiorespiratory Failure Survivors Psychological Distress
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Blueprint
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R34HL145387 | NIH | None | httpsreporternihgovquickSearch1R34HL145387 |