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

Purpose

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.

Condition

  • Surgery

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Alicia Meng, MA
314-273-5016
aliciameng@wustl.edu

More Details

NCT ID
NCT07283783
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Alicia Meng, MA
314-273-5016
aliciameng@wustl.edu