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NCT Number: NCT07283783

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.

Recruiting

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Key information

Conditions

Surgery Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Alicia Meng, MA

CONTACT

[email protected]

314-273-5016

Eric Lenze, M.D.

SUB_INVESTIGATOR

Joanna Abraham, Ph.D., FACMI, FAMIA

CONTACT

[email protected]

314-362-5129

Joanna Abraham, Ph.D., FACMI, FAMIA

PRINCIPAL_INVESTIGATOR

Katherine Holzer, Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Meng, MA

CONTACT

[email protected]

314-273-5016

Joanna Abraham, Ph.D., FACMI, FAMIA

CONTACT

[email protected]

314-362-5129

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Foundation for Barnes-Jewish Hospital

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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