DepressionBlueprint 2NCT06538246
Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
A study testing Blueprint and Education program in people with Depression and Anxiety, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Post-traumatic Stress Disorder
- What is being tested?
- Blueprint and Education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 15 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria Inclusion criteria present in the hospital
- Adult (age ≥18)
- Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met
- Serious acute cardiorespiratory condition, 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 ≥6 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
- evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented)
- urgent cardiac catheterization
- Cognitive status intact
- No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
- Absence of severe mental illness
- Treatment for severe mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia [as per medical record], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission
- Evidence of poorly managed severe mental illness
- No endorsement of suicidality at time of admission or informed consent
- Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)
Inclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital)
- 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
- Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)
- Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up; for example:
- Anticipated surgical procedures
- Anticipated complex medical regiment (e.g., new chemotherapy, new dialysis, need for repeat surgery, pregnant and near term)
- Plan for comfort care
- Other complex needs anticipated that could interfere with the ability to complete study procedures. Examples include:
- Anticipated disruptive travel
- Inability to use mobile app
- Anticipated unstable living situation
- Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice)
- Persistently impaired cognition as a result of illness (Impairment defined as ≥3 errors on the Callahan cognitive status screen and/or the lack of decisional capacity (i.e., patient could be consented by medical team for a procedure if necessary)
- Currently imprisoned or incarcerated or in home detention
- Lack a reliable smartphone with cellular data plan or access to the internet
- Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study
- Previously enrolled in the trial
Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital)
- Failure to randomize within 14 days from planned start date (planned start date is within 3 days post-discharge from the hospital to home to accommodate weekends)
- Readmission to hospital before randomization completed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristy Johnson contact
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Kristy Johnson, kristy.johnson@duke.edu
Christopher Cox, MD
About this study
Official title: Self-directed Mobile Adaptive Coping Skills Intervention to Improve Psychological Distress Symptoms Among Cardiorespiratory Failure Survivors: Blueprint 2
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.
Read more
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.
Read the 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 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.
- Conditions
- Depression, Anxiety, Post-traumatic Stress Disorder, Stress, Worries; Pain or Disability, Breath Shortness
- Being tested
- Blueprint, Education program
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Pain, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueprintBehavioural
This is a mobile app-based adaptive coping skills intervention that lasts 1 month
Education programBehavioural
This is a mobile app-based education program that lasts 1 month
| Study group | Role | What they receive |
|---|---|---|
| Blueprint adaptive coping skills intervention | Experimental | 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. Receives: Behavioral: Blueprint |
| Education program control | Active comparator | 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. Receives: Behavioral: Education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, and 6 months post-randomization
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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)
Measured: Baseline, 1 month, 3 months, and 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Oct 2024
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, University of Colorado, Denver, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Christopher Cox, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538246
- Sponsor's protocol ID
- Pro00115623
- Acronym
- Blueprint 2
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823.
PubMed 38805199Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.
PubMed 29793970Baudier RL, Mosack KE, Lapidus JA, Porter LS, Anderson A, Hope AA, Johnson A, Johnson K, Lesowski K, Avallone Mantelli R, Marentes Ruiz CJ, McDougal M, Mejia-Flores L, Mitchell J, Moss M, Neville TH, Estela Vasquez Guzman C, Vu A, Wolwowicz EL, Hough CL, Morris CD, Cox CE. Blueprint 2: A self-directed mobile adaptive coping skills intervention to improve psychological distress symptoms among cardiorespiratory failure survivors study protocol. Contemp Clin Trials. 2026 Jul;166:108359. doi: 10.1016/j.cct.2026.108359. Epub 2026 May 30.
PubMed 42217309Mosack KE, Guzman CEV, Marentes Ruiz CJ, Wolwowicz E, Johnson K, Mantelli RA, Anderson A, McDougal M, Mejia-Flores L, Gonzalez-Guarda R, Neville TH, Baudier RL, Lapidus JA, Porter LS, Hope AA, Moss M, Morris CD, Hough CL, Cox CE; Blueprint en espanol Writing Group. Development and usability testing of a Spanish version of a mobile app-based adaptive coping skills intervention for critical illness survivors: Blueprint en espanol. Ann Am Thorac Soc. 2026 Oct 1;23(10):1509-1517. doi: 10.1093/annalsats/aaoag089.
PubMed 41967105
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-directed Mobile Adaptive Coping Skills Intervention to Improve Psychological Distress Symptoms Among Cardiorespiratory Failure Survivors: Blueprint 2
- ClinicalTrials.gov ID
- NCT06538246
- Acronym / sponsor ID
- Blueprint 2 / Pro00115623
- Conditions
- Depression, Anxiety, Post-traumatic Stress Disorder, Stress, Worries; Pain or Disability, Breath Shortness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, University of Colorado, Denver, University of California, Los Angeles
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueprint adaptive coping skills intervention | Experimental | Behavioral: BlueprintThis 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. |
| Education program control | Active comparator | Behavioral: Education programThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlueprintThis is a mobile app-based adaptive coping skills intervention that lasts 1 month | Behavioural | Blueprint adaptive coping skills intervention |
| Education programThis is a mobile app-based education program that lasts 1 month | Behavioural | Education program control |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
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.
3 secondary outcomes
Post-Traumatic Stress Syndrome inventory (PTSS)
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
EuroQOL-5D visual analog scale (EQ VAS) quality of life measure
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
Perceived Stress Scale 4-Item survey (PSS-4)
Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Results publication: PubMed 38805199Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823.
- Results publication: PubMed 29793970Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.
- Derived from this study: PubMed 42217309Baudier RL, Mosack KE, Lapidus JA, Porter LS, Anderson A, Hope AA, Johnson A, Johnson K, Lesowski K, Avallone Mantelli R, Marentes Ruiz CJ, McDougal M, Mejia-Flores L, Mitchell J, Moss M, Neville TH, Estela Vasquez Guzman C, Vu A, Wolwowicz EL, Hough CL, Morris CD, Cox CE. Blueprint 2: A self-directed mobile adaptive coping skills intervention to improve psychological distress symptoms among cardiorespiratory failure survivors study protocol. Contemp Clin Trials. 2026 Jul;166:108359. doi: 10.1016/j.cct.2026.108359. Epub 2026 May 30.
- Derived from this study: PubMed 41967105Mosack KE, Guzman CEV, Marentes Ruiz CJ, Wolwowicz E, Johnson K, Mantelli RA, Anderson A, McDougal M, Mejia-Flores L, Gonzalez-Guarda R, Neville TH, Baudier RL, Lapidus JA, Porter LS, Hope AA, Moss M, Morris CD, Hough CL, Cox CE; Blueprint en espanol Writing Group. Development and usability testing of a Spanish version of a mobile app-based adaptive coping skills intervention for critical illness survivors: Blueprint en espanol. Ann Am Thorac Soc. 2026 Oct 1;23(10):1509-1517. doi: 10.1093/annalsats/aaoag089.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristy Johnson contact
Christopher Cox principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueprint and Education program in people with Depression and Anxiety, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Cox (919-681-7232, christopher.cox@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: Baseline, 1 month, 3 months, and 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538246, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.