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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Behavioral: Wellness Program

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicia Meng, MA; Phone Number: 314-273-5016; Email: aliciameng@wustl.edu
• Study Contact Backup: Name: Joanna Abraham, Ph.D., FACMI, FAMIA; Phone Number: 314-362-5129; Email: joannaa@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Eric Lenze, M.D.
      • Sub-Investigator: Katherine Holzer, Ph.D.
      • Contact: Alicia Meng, MA; Phone Number: 314-273-5016; Email: aliciameng@wustl.edu
      • Contact: Joanna Abraham, Ph.D., FACMI, FAMIA; Phone Number: 314-362-5129; Email: joannaa@wustl.edu
      • Principal Investigator: Joanna Abraham, Ph.D., FACMI, FAMIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Wellness Program for Perioperative Mental Health; 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.

Behavioral: Wellness Program; The BCBT intervention consists of 8 to 10 structured sessions delivered remotely via phone or Zoom, beginning in the preoperative period and continuing for approximately three months after surgery. The interventionist will offer a protocolized review of current medications with feedback as appropriate, under guidance by the study psychiatrist. As additional optional components of the Wellness Program, the study team will also offer faith-based counseling as well as the option to involve family and friends as active or passive participants in the program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reach of the study as measured by number of patients who agree to participate in the study out of total eligible to participate	Through completion of enrollment for all participants (estimated to be 9 months, time for participant 1 day)
Reach of the intervention as measured by number of patients who completed the intervention out of patients who agreed to participate in the study	Through completion of follow-up for all participants (estimated to be 12 months, time for participant 3 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of instrument or data fields completed for Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)	Baseline, 1 month after surgery, and 3 months after surgery

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: The Foundation for Barnes-Jewish Hospital
• Investigators: Principal Investigator: Joanna Abraham, Ph.D., FACMI, FAMIA, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Perioperative Care; Anxiety; Polypharmacy; Coordination; Behavioral Treatment; Minority Mental Health; Medication Counseling
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Health Education; Health Promotion
• Other Study ID Numbers: 202511072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data collected during the trial, after deidentification, will be available, upon request. In addition, the study protocol will be available upon request.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers must provide a methodologically sound proposal that meets the approval of the author. Proposals should be directed to joannaa@wustl.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available to the requestor indefinitely via encrypted e-mail service.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No