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

The Washington University

Status: Enrolling

Conditions: Surgery

Treatments: Behavioral: Wellness Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07283783

202511072

Details and patient eligibility

About

In this study, the investigators will evaluate the feasibility of the Wellness Program, including patient recruitment, screening and outcome measures, and feasibility of adapting the intervention with older Black surgical patients who endorse clinically significant symptoms of depression and/or anxiety.

Enrollment: 50 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Wellness Program for Perioperative Mental Health

Experimental group

Description:

Enrolled participants will participate in the study for approximately 3 months after surgery. The participants will complete questionnaires at baseline, 1 month after surgery, and 3 months after surgery. The Wellness Program will consist of Cognitive Behavioral Therapy (CBT) and medication optimization.

Treatment:

Behavioral: Wellness Program