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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07283783
Status
Recruiting
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Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wellness Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 5, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Alicia Meng, MA
[email protected]
314-273-5016
Joanna Abraham, Ph.D., FACMI, FAMIA
[email protected]
314-362-5129
Joanna Abraham, Ph.D., FACMI, FAMIA (PRINCIPAL_INVESTIGATOR)
Katherine Holzer, Ph.D. (SUB_INVESTIGATOR)
Eric Lenze, M.D. (SUB_INVESTIGATOR)

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