Perioperative wellness program for older Black surgical patients

INCLUDE Program: A Perioperative Wellness Program Tailored for Black Surgical Patients

This program will try a perioperative wellness intervention to support older Black patients having surgery who have significant anxiety or depression.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Washington University School of Medicine (other)
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT07283783 on ClinicalTrials.gov

What this trial studies

This is a feasibility project testing a tailored perioperative wellness program delivered to Black or African American patients aged 60 and older who are scheduled for surgery at Washington University/Barnes-Jewish Hospital and who screen positive for clinically significant anxiety or depression (PHQ-ADS ≥10). The study will examine feasibility outcomes including patient recruitment, screening procedures, outcome measure collection, and the practicality of adapting the intervention for this population. Caregivers may be invited to participate if the patient chooses to include them. Patients with severe cognitive impairment, acute suicidality, inability to consent, or those deemed ineligible by the surgeon or PI will be excluded.

Who should consider this trial

Good fit: Ideal candidates are Black or African American adults aged 60 or older who are scheduled for elective oncologic, cardiac, or orthopedic surgery at the Washington University/Barnes-Jewish Hospital system and who have a PHQ-ADS score of 10 or higher and can give informed consent.

Not a fit: Patients with severe cognitive impairment, active suicidal ideation, inability to consent, non-Black patients, or those not having surgery at the study sites are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could reduce perioperative anxiety and depression symptoms and support better recovery and medication management for older Black surgical patients.

How similar studies have performed: Previous perioperative and culturally tailored mental health interventions have shown promise in improving mood and outcomes, but programs specifically tailored for older Black surgical patients remain limited and largely untested.

Eligibility criteria

Inclusion Criteria Patients:

* Age ≥60 years
* Scheduled surgical procedure at BJH or BJWCH (oncologic, cardiac; orthopedic)
* Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10
* Black or African American.

Exclusion Criteria Patients:

* Inability to provide informed consent;
* Severe cognitive impairment screened by the SBT (Short Blessed Test) ≥10
* Acutely suicidal
* Considered ineligible per the discretion of the surgeon or study PI
* Considered ineligible per the discretion of the surgeon or study PI

Caregiver participants:

If patients identify a caregiver that the patient would like to include in their Wellness Program, the caregiver will be invited to consent. Patients will provide contact information for their caregiver.

Where this trial is running

St Louis, Missouri

• Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Joanna Abraham, Ph.D., FACMI, FAMIA — Washington University School of Medicine
• Study coordinator: Alicia Meng, MA

Conditions: Surgery, Perioperative Care, Minority Mental Health, Anxiety, Depression, Polypharmacy, Behavioral Treatment, Medication Counseling