INCLUDE Program: A Perioperative Wellness Program Tailored for Black Surgical Patients
Recruiting · NCT07283783 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Wellness Program
What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States