Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538246
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Self-directed Mobile Adaptive Coping Skills Intervention to Improve Psychological Distress Symptoms Among Cardiorespiratory Failure Survivors Blueprint 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Blueprint 2
Brief Summary:
Conditions treated in intensive care units ICUs such as the acute respiratory distress syndrome ARDS congestive heart failure COVID pneumonia and sepsis are common These can lead to high rates of depression anxiety and PTSD that worsen quality of life Yet there are few effective strategies able to overcome barriers of limited access to mental health care Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they havent been included well in past research
To address this problem the investigators developed Blueprint a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms The investigators found that it reduced depression symptoms and improved quality of life compared to placebo
To confirm these promising findings the investigators are doing a formal test of Blueprint The investigators will enroll 400 people who received ICU care from 4 hospitals Duke UCLA Colorado and Oregon These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed -both delivered through similar mobile app platforms Our specific aims are to see which program improves symptoms better across 6 months of follow up
This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity
To address this problem the investigators developed Blueprint a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms The investigators found that it reduced depression symptoms and improved quality of life compared to placebo
To confirm these promising findings the investigators are doing a formal test of Blueprint The investigators will enroll 400 people who received ICU care from 4 hospitals Duke UCLA Colorado and Oregon These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed -both delivered through similar mobile app platforms Our specific aims are to see which program improves symptoms better across 6 months of follow up
This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity
Detailed Description:
Cardiorespiratory conditions such as the acute respiratory distress syndrome ARDS congestive heart failure COVID pneumonia and sepsis are among the most common causes of mortality and morbidity They are also notable for high rates of persistent psychological distress symptoms including depression anxiety and PTSD that worsen quality of life and outcomes of the underlying conditions Yet there are few effective strategies able to overcome barriers of limited access to mental health care Even less is known about distress management among people from structurally disadvantaged backgrounds such as racially and ethnically minoritized populations because of their suboptimal representation in relevant clinical trials
To fill this gap the investigators developed Blueprint an adaptive coping skills training intervention and have optimized it over years of research The investigators conducted a multicenter RCT PCORI PFA 195 of a telephone- and web-based version among those recently hospitalized with serious cardiorespiratory conditions finding that it reduced depression symptoms and improved quality of life among those with elevated baseline distress Informed by lessons learned about intervention delivery and eligibility criteria the investigators next conducted a single-center pilot RCT R34 HL145387 that targeted a broader population and tested a completely automated self-guided symptom-responsive mobile app version of Blueprint The investigators found excellent adherence and a strong effect on depression anxiety PTSD and quality of life compared to control
Given these promising findings a formal test of the Blueprint adaptive coping skills training interventions efficacy is needed Therefore the investigators propose a 5-year multicenter RCT with 6-month follow up in which 400 cardiorespiratory failure survivors with elevated symptoms of psychological distress post-discharge are randomized to either Blueprint or an Education Program control-both delivered through similar mobile app platforms Our specific aims will 1 Test Blueprint vs control on symptoms of depression anxiety PTSD and quality of life 2 Determine patient-level characteristics associated with a great treatment response among sociodemographic subgroups of interest also applying a heterogeneity of treatment effects analysis to identify other groups of clinical relevance and 3 Ensure off-the-shelf intervention readiness for implementation by using an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates semi-structured interviews with trial participants and quantitative trial data from Aims 1 and 2
Innovative elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories a focus on racially and ethnically minoritized persons the integration of a Spanish language intervention version and strong community engagement This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity
To fill this gap the investigators developed Blueprint an adaptive coping skills training intervention and have optimized it over years of research The investigators conducted a multicenter RCT PCORI PFA 195 of a telephone- and web-based version among those recently hospitalized with serious cardiorespiratory conditions finding that it reduced depression symptoms and improved quality of life among those with elevated baseline distress Informed by lessons learned about intervention delivery and eligibility criteria the investigators next conducted a single-center pilot RCT R34 HL145387 that targeted a broader population and tested a completely automated self-guided symptom-responsive mobile app version of Blueprint The investigators found excellent adherence and a strong effect on depression anxiety PTSD and quality of life compared to control
Given these promising findings a formal test of the Blueprint adaptive coping skills training interventions efficacy is needed Therefore the investigators propose a 5-year multicenter RCT with 6-month follow up in which 400 cardiorespiratory failure survivors with elevated symptoms of psychological distress post-discharge are randomized to either Blueprint or an Education Program control-both delivered through similar mobile app platforms Our specific aims will 1 Test Blueprint vs control on symptoms of depression anxiety PTSD and quality of life 2 Determine patient-level characteristics associated with a great treatment response among sociodemographic subgroups of interest also applying a heterogeneity of treatment effects analysis to identify other groups of clinical relevance and 3 Ensure off-the-shelf intervention readiness for implementation by using an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates semi-structured interviews with trial participants and quantitative trial data from Aims 1 and 2
Innovative elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories a focus on racially and ethnically minoritized persons the integration of a Spanish language intervention version and strong community engagement This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None