Cardiac SurgeryNCT05575128
Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures
A study testing Behavioral activation, Medication optimzation and Care as usual in people with Cardiac Surgery and Older Adults, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing cardiac surgery (compared with usual care), while examining implementation outcomes. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiac Surgery, Older Adults, Depression
- What is being tested?
- Behavioral activation, Medication optimzation and Care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2022to 29 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults ≥ 60 years
- Scheduled major cardiac procedure
- PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms
Who cannot join
- Barrier to communication (Unable to read, speak, and understand English)
- Severe cognitive impairment screened by the SBT (Short Blessed Test) >10
- Acutely suicidal
- Previous participation in this study or CPMH feasibility study 202101103.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Cardiac Procedures
This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing cardiac surgery (compared with usual care), while examining implementation outcomes.
- Conditions
- Cardiac Surgery, Older Adults, Depression, Anxiety
- Being tested
- Behavioral activation, Medication optimzation, Care as usual
- Keywords
- Behavioral activation, medication optimization, cardiac surgery, perioperative mental health
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral activationBehavioural
The behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values
Medication optimzationOther
Medication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment.
Care as usualOther
Care as usual, with written resources provided
| Study group | Role | What they receive |
|---|---|---|
| Behavioral activation and medication optimization | Experimental | Behavioral activation (BA) will begin perioperatively and will span across 3 months postoperatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition.
Medications will be reviewed by a team of interventionists to minimize brain-toxic medications and optimize doses of antidepressants and other mental health medications. In-hospital and after discharge, the interventionists' role will include coordinating with the care teams to ensure that medication changes that were introduced preoperatively are maintained. Receives: Behavioral: Behavioral activation; Other: Medication optimzation |
| Control (treatment as usual) | Other | Participants in control arm will continue care as usual. They will receive printed resources for supporting sleep hygiene, stress reduction, cognitive and mental health exercises, as well as community resources for older adults. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-ADS
Change in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively will be compared between the two study arms 3 months after surgery.
PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety)
Measured: baseline and 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start5 Nov 2022
- Primary completion20 Mar 2025
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid Type 1 effectiveness-implementation randomized controlled trial design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, simon.haroutounian, Washington University School of Medicine
- Investigators
- Simon Haroutounian, PharmD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575128
- Sponsor's protocol ID
- 202209033
- Other IDs
- P50MH122351
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2022
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abraham J, Holzer KJ, Haroutounian S, Pennington B, Baumann A, Calfee R, Cordner T, Freedland KE, Kannampallil T, Kozower B, Lenard E, Miller JP, Politi M, Yingling M, Avidan MS, Lenze EJ. Perioperative Depression and Anxiety Care in Older Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2632619. doi: 10.1001/jamanetworkopen.2026.32619.
PubMed 42714910Holzer KJ, Bartosiak KA, Calfee RP, Hammill CW, Haroutounian S, Kozower BD, Cordner TA, Lenard EM, Freedland KE, Tellor Pennington BR, Wolfe RC, Miller JP, Politi MC, Zhang Y, Yingling MD, Baumann AA, Kannampallil T, Schweiger JA, McKinnon SL, Avidan MS, Lenze EJ, Abraham J. Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials. BMJ Open. 2024 Apr 3;14(4):e082656. doi: 10.1136/bmjopen-2023-082656.
PubMed 38569683Pennington BRT, Holzer KJ, Fritz BA, Haroutounian S, Xu KY, Tedder A, Kronzer A, Avidan MS, Lenze EJ. Brain-Hazardous Medications and Potential Subadequate Antidepressant Dosing in Older Surgical Patients Receiving Home Antidepressants: An Observational Study of a Large US Health System. Anesth Analg. 2024 Jul 1;139(1):155-164. doi: 10.1213/ANE.0000000000006952. Epub 2024 Mar 20.
PubMed 38507476
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Cardiac Procedures
- ClinicalTrials.gov ID
- NCT05575128
- Acronym / sponsor ID
- 202209033
- Conditions
- Cardiac Surgery, Older Adults, Depression, Anxiety
- Keywords
- Behavioral activation, medication optimization, cardiac surgery, perioperative mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Posted 9 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing cardiac surgery (compared with usual care), while examining implementation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Hybrid Type 1 effectiveness-implementation randomized controlled trial design
| Arm | Type | Receives |
|---|---|---|
| Behavioral activation and medication optimization | Experimental | Behavioral: Behavioral activation, Other: Medication optimzationBehavioral activation (BA) will begin perioperatively and will span across 3 months postoperatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. Medications will be reviewed by a team of interventionists to minimize brain-toxic medications and optimize doses of antidepressants and other mental health medications. In-hospital and after discharge, the interventionists' role will include coordinating with the care teams to ensure that medication changes that were introduced preoperatively are maintained. |
| Control (treatment as usual) | Other | Other: Care as usualParticipants in control arm will continue care as usual. They will receive printed resources for supporting sleep hygiene, stress reduction, cognitive and mental health exercises, as well as community resources for older adults. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 60 years
- Scheduled major cardiac procedure
- PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms
Key exclusion criteria (4 listed)
- Barrier to communication (Unable to read, speak, and understand English)
- Severe cognitive impairment screened by the SBT (Short Blessed Test) >10
- Acutely suicidal
- Previous participation in this study or CPMH feasibility study 202101103.
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 |
|---|---|---|
| Behavioral activationThe behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values | Behavioural | Behavioral activation and medication optimization |
| Medication optimzationMedication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment. | Other | Behavioral activation and medication optimization |
| Care as usualCare as usual, with written resources provided | Other | Control (treatment as usual) |
Primary outcome
PHQ-ADS
Time frame: baseline and 3 months post-operatively
Change in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively will be compared between the two study arms 3 months after surgery. PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42714910Abraham J, Holzer KJ, Haroutounian S, Pennington B, Baumann A, Calfee R, Cordner T, Freedland KE, Kannampallil T, Kozower B, Lenard E, Miller JP, Politi M, Yingling M, Avidan MS, Lenze EJ. Perioperative Depression and Anxiety Care in Older Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2632619. doi: 10.1001/jamanetworkopen.2026.32619.
- Derived from this study: PubMed 38569683Holzer KJ, Bartosiak KA, Calfee RP, Hammill CW, Haroutounian S, Kozower BD, Cordner TA, Lenard EM, Freedland KE, Tellor Pennington BR, Wolfe RC, Miller JP, Politi MC, Zhang Y, Yingling MD, Baumann AA, Kannampallil T, Schweiger JA, McKinnon SL, Avidan MS, Lenze EJ, Abraham J. Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials. BMJ Open. 2024 Apr 3;14(4):e082656. doi: 10.1136/bmjopen-2023-082656.
- Derived from this study: PubMed 38507476Pennington BRT, Holzer KJ, Fritz BA, Haroutounian S, Xu KY, Tedder A, Kronzer A, Avidan MS, Lenze EJ. Brain-Hazardous Medications and Potential Subadequate Antidepressant Dosing in Older Surgical Patients Receiving Home Antidepressants: An Observational Study of a Large US Health System. Anesth Analg. 2024 Jul 1;139(1):155-164. doi: 10.1213/ANE.0000000000006952. Epub 2024 Mar 20.
- Individual participant dataSharing planned: No
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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.
Simon Haroutounian, PharmD 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 Behavioral activation, Medication optimzation and Care as usual in people with Cardiac Surgery and Older Adults, 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 3 inclusion and 4 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 9 Apr 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?
Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PHQ-ADS (time frame: baseline and 3 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575128, which also lists 3 linked publications.
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 9 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.