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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07283783
Enrollment
50
Registered
2025-12-16
Start date
2026-01-05
Completion date
2026-12-30
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Perioperative Care, Minority Mental Health, Anxiety, Depression, Polypharmacy, Behavioral Treatment, Medication Counseling, Coordination

Brief summary

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.

Interventions

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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
The Foundation for Barnes-Jewish Hospital
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Reach of the study as measured by number of patients who agree to participate in the study out of total eligible to participateThrough 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 studyThrough completion of follow-up for all participants (estimated to be 12 months, time for participant 3 months)

Secondary

MeasureTime 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

Countries

United States

Contacts

CONTACTAlicia Meng, MA
aliciameng@wustl.edu314-273-5016
CONTACTJoanna Abraham, Ph.D., FACMI, FAMIA
joannaa@wustl.edu314-362-5129
PRINCIPAL_INVESTIGATORJoanna Abraham, Ph.D., FACMI, FAMIA

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026