SurgeryNCT07283783
INCLUDE Program: A Perioperative Wellness Program Tailored for Black Surgical Patients
A study testing Wellness Program in people with Surgery, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Wellness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Surgery
- Being tested
- Wellness Program
- Keywords
- Perioperative Care, Minority Mental Health, Anxiety, Depression, Polypharmacy, Behavioral Treatment, Medication Counseling, Coordination
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| Wellness Program for Perioperative Mental Health | Experimental | 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. Receives: Behavioral: Wellness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of the study as measured by number of patients who agree to participate in the study out of total eligible to participate
Measured: Through 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 study
Measured: 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)
Measured: Baseline, 1 month after surgery, and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start5 Jan 2026
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Joanna Abraham, Ph.D., FACMI, FAMIA, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283783
- Sponsor's protocol ID
- 202511072
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial, after deidentification, will be available, upon request. In addition, the study protocol will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCLUDE Program: A Perioperative Wellness Program Tailored for Black Surgical Patients
- ClinicalTrials.gov ID
- NCT07283783
- Acronym / sponsor ID
- 202511072
- Conditions
- Surgery
- Keywords
- Perioperative Care, Minority Mental Health, Anxiety, Depression, Polypharmacy, Behavioral Treatment, Medication Counseling, Coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wellness Program for Perioperative Mental Health | Experimental | Behavioral: Wellness ProgramEnrolled 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness ProgramThe 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. | Behavioural | Wellness Program for Perioperative Mental Health |
Primary outcome
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)
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial, after deidentification, will be available, upon request. In addition, the study protocol will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Abraham, Ph.D., FACMI, FAMIA principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Program in people with Surgery, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.