An interventional study of Blueprint and Education program in Depression, Anxiety and Post-traumatic Stress Disorder, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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 haven't 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.
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 intervention's 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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 400 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Inclusion criteria present in the hospital
Serious acute cardiorespiratory condition, defined as ≥1 of the following:
Cognitive status intact
Absence of severe mental illness
Inclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital)
1. Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and Distress Scale (HADS) total score ≥8
Exclusion Criteria Exclusion criteria present in the hospital
Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up; for example:
Other complex needs anticipated that could interfere with the ability to complete study procedures. Examples include:
Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a unique adaptive coping skills intervention developed over years of research that targets patients hospitalized for cardiorespiratory conditions. Participants will receive 4 weeks of different Blueprint content through a mobile app. Each week's session includes a within-app HADS survey for safety monitoring. A printed or PDF workbook with complementary content and QR links to app videos is provided.
Behavioral: Blueprint
This is cardiorespiratory condition-specific content through an iterative process, informed by research on informational needs and past successful education programs. Participants will receive 4 weeks of different 10-minute informational videos unrelated to Blueprint content through a mobile app. Each week's session includes a within-app HADS survey for safety monitoring. A printed or PDF workbook with complementary content and QR links to app videos is provided.
Behavioral: Education program
This is a mobile app-based adaptive coping skills intervention that lasts 1 month
This is a mobile app-based education program that lasts 1 month
Hospital Anxiety and Depression Scale (HADS)
The HADS evaluates anxiety (7 items) and depression (7 items) with a 14-item instrument assessing symptoms on a 4-point scale rated from 0 "not at all" to 3 "very often indeed". It has a score range of 0 to 42 with higher scores indicating more symptoms.
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
Post-Traumatic Stress Syndrome inventory (PTSS)
The PTSS rates 10 post-traumatic stress symptoms and has a score range of 10 (no symptoms) to 70 (high burden of symptoms).
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
EuroQOL-5D visual analog scale (EQ VAS) quality of life measure
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
Perceived Stress Scale 4-Item survey (PSS-4)
This is a 4-item short version of the PSS. Scores can range from 0 (lowest stress) to 16 (highest level of stress)
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
Patient Health Questionnaire 10-Item symptoms scale (PHQ-10)
The PHQ-10 is an adapted version of the PHQ-15, a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst).
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
Plan to share: Yes — Plan to share deidentified data via an approved and secure data sharing source on completion of the study and publication of results, as per NIH guidelines.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Per NIH guidelines
Access criteria: To be determined
Started Oct 2024 (actual). Primary completion is estimated for Nov 2027, 37 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 37 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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