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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH122351 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral activation | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and 3 months post-operatively |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Haroutounian, PharmD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38569683 | Derived | Holzer 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. | |
| 38507476 |
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1,233 cardiac patients were assessed for eligibility, 687 did not meet inclusion criteria, 369 declined participation, and 72 were excluded for other reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Activation and Medication Optimization | 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. Behavioral activation: 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 optimzation: 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. |
| FG001 | Control (Treatment as Usual) | 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. Care as usual: Care as usual, with written resources provided |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Activation and Medication Optimization | 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. Behavioral activation: 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 optimzation: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Least Squares Mean | Standard Error | Points | baseline and 3 months post-operatively |
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From randomization through completion of study (estimated to be about 4-6 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Activation and Medication Optimization | 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. Behavioral activation: 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 optimzation: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon Haroutounian, PhD, Msc, Russell D and Mary B Shelden Professor of Anesthesiology | Washington University School of Medicine | 314-286-1715 | sharout@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2023 | Mar 9, 2026 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2025 | Jun 3, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 29, 2025 | Mar 9, 2026 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Hybrid Type 1 effectiveness-implementation randomized controlled trial design
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Study staff responsible for administering ratings and collecting outcomes throughout the study are blinded. The investigator(s) are also blinded. This blinding is kept throughout the study until data collection is complete. At the end of the follow-up, the study coordinator will complete a blinding question to try to guess the arm to which each participant was allocated.
| Medication optimzation | Other | 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 usual | Other | Care as usual, with written resources provided |
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| Derived |
| Pennington 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. |
| Medical Condition |
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| Missed Collection Window |
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| BG001 | Control (Treatment as Usual) | 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. Care as usual: Care as usual, with written resources provided |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control (Treatment as Usual) | 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. Care as usual: Care as usual, with written resources provided |
|
|
| 6 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Control (Treatment as Usual) | 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. Care as usual: Care as usual, with written resources provided | 1 | 52 | 0 | 52 | 0 | 52 |
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