{"protocolSection":{"identificationModule":{"nctId":"NCT05575128","orgStudyIdInfo":{"id":"202209033"},"secondaryIdInfos":[{"id":"P50MH122351","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50MH122351"}],"organization":{"fullName":"Washington University School of Medicine","class":"OTHER"},"briefTitle":"Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures","officialTitle":"Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Cardiac Procedures"},"statusModule":{"statusVerifiedDate":"2026-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-11-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-03-20","type":"ACTUAL"},"completionDateStruct":{"date":"2025-03-29","type":"ACTUAL"},"studyFirstSubmitDate":"2022-10-07","studyFirstSubmitQcDate":"2022-10-07","studyFirstPostDateStruct":{"date":"2022-10-12","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-03-11","resultsFirstSubmitQcDate":"2026-03-30","resultsFirstPostDateStruct":{"date":"2026-04-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-03-30","lastUpdatePostDateStruct":{"date":"2026-04-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"simon.haroutounian","investigatorTitle":"Assoc Prof of Anesthesiology","investigatorAffiliation":"Washington University School of Medicine"},"leadSponsor":{"name":"Washington University School of Medicine","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"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."},"conditionsModule":{"conditions":["Cardiac Surgery","Older Adults","Depression","Anxiety"],"keywords":["Behavioral activation","medication optimization","cardiac surgery","perioperative mental health"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Hybrid Type 1 effectiveness-implementation randomized controlled trial design","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","maskingDescription":"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.","whoMasked":["INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":105,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Behavioral activation and medication optimization","type":"EXPERIMENTAL","description":"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.\n\nMedications 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.","interventionNames":["Behavioral: Behavioral activation","Other: Medication optimzation"]},{"label":"Control (treatment as usual)","type":"OTHER","description":"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.","interventionNames":["Other: Care as usual"]}],"interventions":[{"type":"BEHAVIORAL","name":"Behavioral activation","description":"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","armGroupLabels":["Behavioral activation and medication optimization"]},{"type":"OTHER","name":"Medication optimzation","description":"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.","armGroupLabels":["Behavioral activation and medication optimization"]},{"type":"OTHER","name":"Care as usual","description":"Care as usual, with written resources provided","armGroupLabels":["Control (treatment as usual)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"PHQ-ADS","description":"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.\n\nPHQ-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)","timeFrame":"baseline and 3 months post-operatively"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n* Adults ≥ 60 years\n* Scheduled major cardiac procedure\n* PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms\n\nExclusion criteria:\n\n* Barrier to communication (Unable to read, speak, and understand English)\n* Severe cognitive impairment screened by the SBT (Short Blessed Test) \\>10\n* Acutely suicidal\n* Previous participation in this study or CPMH feasibility study 202101103.","healthyVolunteers":false,"sex":"ALL","minimumAge":"60 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Simon Haroutounian, PharmD","affiliation":"Washington University School of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Washington University in St. Louis","city":"St Louis","state":"Missouri","zip":"63110","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}}]},"referencesModule":{"references":[{"pmid":"42714910","type":"DERIVED","citation":"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."},{"pmid":"38569683","type":"DERIVED","citation":"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."},{"pmid":"38507476","type":"DERIVED","citation":"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."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"1,233 cardiac patients were assessed for eligibility, 687 did not meet inclusion criteria, 369 declined participation, and 72 were excluded for other reasons.","groups":[{"id":"FG000","title":"Behavioral Activation and Medication Optimization","description":"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.\n\nMedications 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.\n\nBehavioral 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\n\nMedication 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."},{"id":"FG001","title":"Control (Treatment as Usual)","description":"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.\n\nCare as usual: Care as usual, with written resources provided"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"52"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"47"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Medical Condition","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Missed Collection Window","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Behavioral Activation and Medication Optimization","description":"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.\n\nMedications 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.\n\nBehavioral 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\n\nMedication 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."},{"id":"BG001","title":"Control (Treatment as Usual)","description":"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.\n\nCare as usual: Care as usual, with written resources provided"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"102"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"70.6","spread":"6.1"},{"groupId":"BG001","value":"68.1","spread":"5.7"},{"groupId":"BG002","value":"69.3","spread":"6.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"52"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"50"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"18"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"83"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"102"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"PHQ-ADS","description":"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.\n\nPHQ-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)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Points","timeFrame":"baseline and 3 months post-operatively","groups":[{"id":"OG000","title":"Behavioral Activation and Medication Optimization","description":"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.\n\nMedications 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.\n\nBehavioral 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\n\nMedication 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."},{"id":"OG001","title":"Control (Treatment as Usual)","description":"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.\n\nCare as usual: Care as usual, with written resources provided"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"18.39","spread":"1.15"},{"groupId":"OG001","value":"18.59","spread":"1.16"}]}]},{"title":"Month 1","categories":[{"measurements":[{"groupId":"OG000","value":"12.33","spread":"1.21"},{"groupId":"OG001","value":"11.67","spread":"1.19"}]}]},{"title":"Month 3","categories":[{"measurements":[{"groupId":"OG000","value":"9.72","spread":"1.23"},{"groupId":"OG001","value":"12.60","spread":"1.20"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"From randomization through completion of study (estimated to be about 4-6 months).","eventGroups":[{"id":"EG000","title":"Behavioral Activation and Medication Optimization","description":"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.\n\nMedications 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.\n\nBehavioral 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\n\nMedication 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.","deathsNumAffected":6,"deathsNumAtRisk":53,"seriousNumAffected":0,"seriousNumAtRisk":53,"otherNumAffected":0,"otherNumAtRisk":53},{"id":"EG001","title":"Control (Treatment as Usual)","description":"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.\n\nCare as usual: Care as usual, with written resources provided","deathsNumAffected":1,"deathsNumAtRisk":52,"seriousNumAffected":0,"seriousNumAtRisk":52,"otherNumAffected":0,"otherNumAtRisk":52}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Simon Haroutounian, PhD, Msc, Russell D and Mary B Shelden Professor of Anesthesiology","organization":"Washington University School of Medicine","email":"sharout@wustl.edu","phone":"314-286-1715"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2023-10-30","uploadDate":"2026-03-09T15:19","filename":"Prot_003.pdf","size":277662},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2025-05-29","uploadDate":"2025-06-03T14:01","filename":"SAP_002.pdf","size":256577},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2025-05-29","uploadDate":"2026-03-09T15:23","filename":"ICF_004.pdf","size":359426}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"},{"id":"D001008","term":"Anxiety Disorders"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D001523","term":"Mental Disorders"}]}},"hasResults":true}