A Phase 1/2 interventional study of Promoting Resilience in Stress Management (PRISM) in Discrimination, Racial, Communication and Chronic Illness, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Washington · Phase 1/2, Interventional, and Supportive care
This is a pilot randomized trial of 60 patients to test feasibility, acceptability and efficacy of PRISM to improve resilience and facilitate improved patient-clinician communication in racially minorities patients with serious illness.
Promoting Resilience in Stress Management (PRISM): PRISM is based on stress and coping theory and prior research. It is designed to improve resilience for patients with serious illness and, for this study, has been modified for patients who have experienced healthcare discrimination. The development of this novel resilience resource intervention is based off of a conceptual framework of resilience and affirmed relationships between resilience resources and outcomes. PRISM consists of five, one-on-one sessions lasting 30-50 minutes targeting specific teachable resilience skills: stress management, problem solving, goal setting, benefit finding, and meaning making. Biobehavioral models suggest that these resources are related to health-related quality of life, health behaviors, and self-advocacy. PRISM was refined with expert opinion and interviews with patients, psychologists, and social workers. Initially designed for and successfully tested in seriously ill adolescents and young adults (AYAs) with advanced cancer, PRISM has been successfully deployed in AYAs with diabetes and parents of seriously ill AYAs. It is undergoing testing in patients with cystic fibrosis, chronic renal failure, craniofacial surgery, and adult congenital heart disease.
Patients will be identified and approached, study goals explained, and consent obtained prior to enrollment. Participants will complete three surveys: enrollment, 1- and 3- months post randomization. At enrollment, they will complete demographic information, and the Discrimination in Medical Setting (DMS), Microaggressions in Health Care (MHCS), and Group Based Medial Mistrust (GBMM) scales. Patients will be randomized 1:1 to either PRISM or usual care. Retention will be optimized via monthly contacts with all patients. A calendar of appointments and study procedures will be created at randomization. Strategies used during the collection of preliminary data for this proposal are described and utilized in Aim 1 to help facilitate survey completion will be employed. Patients will receive reminder phone-calls and emails 1 week before each survey, and in-person check-ins during clinic visits during a 2-week window around each survey. If surveys are not completed within 1 week, participants will receive a phone call and email to assess willingness to participate and remind them.
PRISM is designed to be delivered by trained research associates to optimize dissemination. Interventionists in prior trials have not held advanced degrees and there are no detectable differences in fidelity or patient-engagement based on professional background. For this pilot, I will conduct the intervention to facilitate feasibility and gain experience to train future interventionalists. Sessions will occur at a time convenient to the patient with the first session to occur within 1 week of enrollment. If the patient is discharged, the intervention can continue in the outpatient setting in-person or by HIPPA-compliant Zoom. After completion, participants will receive weekly "booster" contacts (invitations to practice reviewing certain skills) until the occurrence of a planned patient-clinician conversation, facilitated and arranged by study staff during the 5th session. All participants will receive paper worksheets to practice skills between sessions, plus access to a free, digital PRISM app (available only for patients enrolled in PRISM). The app was designed and programed by two Seattle-based companies [Artefact (artefactgroup.com) and General UI (generalui.com)], 3 prior PRISM recipients, a family-advisory team, and the Seattle Children's Hospital Digital Health team. It is available on both iOS and Android platforms and includes the same exercises as the worksheets. The app includes links to social media and resources with options to enable push notifications and reminders. A digital interface allows study staff to track user frequency, length spent on each practice page, and use over time.
47 studies on the registry are indexed under Racism; 8 are open to participants now.
This study's enrollment of 28 is below the median of 106 across 34 interventional studies indexed under Racism.
Browse Racism studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will be recipients of the PRISM intervention
Behavioral: Promoting Resilience in Stress Management (PRISM)
Patients in this arm will not receive the PRISM intervention, but will continue to receive usual care the discretion of their treating clinicians.
PRISM is a novel resilience resource intervention consisting of five, one-on-one sessions lasting 30-50 minutes targeting specific teachable resilience skills: stress management, problem solving, goal setting, benefit finding, and meaning making. Sessions will occur at a time convenient to the patient with the first session to occur within 1 week of enrollment either while inpatient or if the patient is discharged, in the outpatient setting in-person or by HIPPA-compliant Zoom. After completion, participants will receive weekly "booster" contacts (invitations to practice reviewing certain skills) until the occurrence of a planned patient-clinician conversation, facilitated and arranged by study staff during the 5th session. All participants will receive paper worksheets to practice skills between sessions, plus access to a free, digital PRISM app (available only for patients enrolled in PRISM).
10-item Connor-Davidson Resilience Scale (CD-RISC)
We will measure the change the Connor-Davidson Resilience Scale (CD-RISC 10) between enrollment and at 3-months after randomization. in The 10-item Connor-Davidson Resilience Scale (CD-RISC) is is composed of 10 items from an original 25-item CD-RISC scale. Scores correlate with the full 25-item scale. Respondents rate their agreement with the survey items on a 5-point Likert scale from 0 (not true at all) to 4 (nearly true all the time). It is scored by the sum of all items with a range between 0-40 with higher scores indicating higher patient-reported resilience.
Time frame: 3 months
Patients eligible for screening will be Black patients hospitalized at Harborview Medical Center on an internal medicine or cardiology service. Potential participants will be screened in the electronic medical record. Eligible patients will be Black, diagnosed with a serious illness associated with a median expected survival of two years or less, English-speaking, age 18 years and older, and with no cognitive impairment.
| Milestone | PRISM | Usual Care |
|---|---|---|
| Started | 13 | 15 |
| Completed enrollment cd-risc | 13 | 15 |
| Completed | 6 | 1 |
| Not completed | 7 | 14 |
We will measure the change the Connor-Davidson Resilience Scale (CD-RISC 10) between enrollment and at 3-months after randomization. in The 10-item Connor-Davidson Resilience Scale (CD-RISC) is is composed of 10 items from an original 25-item CD-RISC scale. Scores correlate with the full 25-item scale. Respondents rate their agreement with the survey items on a 5-point Likert scale from 0 (not true at all) to 4 (nearly true all the time). It is scored by the sum of all items with a range between 0-40 with higher scores indicating higher patient-reported resilience.
| average of number of units on a scale | PRISM | Usual Care |
|---|---|---|
| 10-item Connor-Davidson Resilience Scale (CD-RISC) | 0.67 ± 4.8 | 0 ± 0 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRISM | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Usual Care | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(Years) | PRISM | Usual Care | Total |
|---|---|---|---|
| Mean | 64.2 ± 11.6 | 50 ± 0 | 61.5 ± 13.0 |
| Sex: Female, Male(Participants) | PRISM | Usual Care | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | PRISM | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 1 | 7 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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