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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Wellness Program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No