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

Washington University School of Medicine50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

Wellness ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

RECRUITING

Outcomes

Primary Outcomes

Reach of the study as measured by number of patients who agree to participate in the study out of total eligible to participate

Time frame: 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

Time frame: Through completion of follow-up for all participants (estimated to be 12 months, time for participant 3 months)

Secondary Outcomes

Percentage of instrument or data fields completed for Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Time frame: Baseline, 1 month after surgery, and 3 months after surgery

Central Contacts

Alicia Meng, MA

CONTACT

314-273-5016 aliciameng@wustl.edu

Joanna Abraham, Ph.D., FACMI, FAMIA

CONTACT

314-362-5129 joannaa@wustl.edu

Data from ClinicalTrials.gov

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