Is NCT06538246 recruiting in Durham, NC?

Yes, NCT06538246 is currently recruiting participants at its Durham, NC location. This depression clinical trial is actively enrolling qualified participants.

How do I join the depression clinical trial in Durham?

To join this clinical trial in Durham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Durham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Depression Clinical Trial in Durham, NC

About This Depression Study in Durham

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.

Sponsor: Duke University

Who Can Participate

Inclusion Criteria

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) 1\. Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and Distress Scale (HADS) total score ≥8

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT06538246) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Depression Treatment Options in Durham, NC

If you're searching for depression treatment options in Durham, NC, this clinical trial (NCT06538246) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced depression specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all depression clinical trials near you to find additional studies recruiting in your area.

Depression Clinical Trial in Durham, NC

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