{"protocolSection":{"identificationModule":{"nctId":"NCT05685511","orgStudyIdInfo":{"id":"202212097"},"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 For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery","officialTitle":"Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery"},"statusModule":{"statusVerifiedDate":"2026-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-03-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-07-12","type":"ACTUAL"},"completionDateStruct":{"date":"2024-07-12","type":"ACTUAL"},"studyFirstSubmitDate":"2023-01-05","studyFirstSubmitQcDate":"2023-01-05","studyFirstPostDateStruct":{"date":"2023-01-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-03-11","resultsFirstSubmitQcDate":"2026-03-11","resultsFirstPostDateStruct":{"date":"2026-03-31","type":"ACTUAL"},"dispFirstSubmitDate":"2025-01-29","dispFirstPostDateStruct":{"date":"2024-11-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-03-11","lastUpdatePostDateStruct":{"date":"2026-03-31","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"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":"Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes."},"conditionsModule":{"conditions":["Older Adults","Anxiety","Depression","Major Surgical Resection of a Thoracic Malignancy","Major Surgical Resection of an Abdominal Malignancy"],"keywords":["behavioral activation","medication optimization","thoracic surgery","oncologic surgery","perioperative mental health"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","maskingDescription":"Study staff responsible for administering ratings throughout the study are 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. This will allow to determine whether the blinding procedures in the study were effective.","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":105,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Usual Care","type":"ACTIVE_COMPARATOR","description":"Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.","interventionNames":["Other: Usual care resources"]},{"label":"Intervention Bundle (Behavioral Activation + Medication Optimization)","type":"EXPERIMENTAL","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.\n* Medications will be reviewed \\& optimized by a team of interventionists including a psychiatrist, pharmacologist, \\& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \\& that no new inappropriate medications are initiated. After discharge, \\& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.","interventionNames":["Behavioral: Behavioral Activation","Other: Medication Optimization"]}],"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":["Intervention Bundle (Behavioral Activation + Medication Optimization)"]},{"type":"OTHER","name":"Medication Optimization","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":["Intervention Bundle (Behavioral Activation + Medication Optimization)"]},{"type":"OTHER","name":"Usual care resources","description":"List of resources that the patient can explore on their own","armGroupLabels":["Usual Care"]}]},"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.\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\nPre-screening:\n\nTo be considered for participation, patients will be screened using PHQ-4 questionnaire. Scores \\>3 will indicate positive pre-screen (i.e. can be considered for participation and formal screening). Scores \\< 3 will indicate negative screen (i.e. patient not considered for formal screening due to low risk for anxiety or depression).\n\nScreening:\n\n* Adults age ≥60 years\n* Scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy\n* PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥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* Considered ineligible per the discretion of the oncologic surgeon or study PI\n* Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.","healthyVolunteers":false,"sex":"ALL","minimumAge":"60 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Benjamin D Kozower, M.D., MPH","affiliation":"Washington University School of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Washington University School of Medicine","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."}],"seeAlsoLinks":[{"label":"Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine","url":"http://www.siteman.wustl.edu"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"813 oncologic patients were assessed for eligibility, 330 did not meet inclusion criteria, 324 declined participation, and 54 were excluded for other reasons.","groups":[{"id":"FG000","title":"Intervention Bundle (Behavioral Activation + Medication Optimization)","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.\n* Medications will be reviewed \\& optimized by a team of interventionists including a psychiatrist, pharmacologist, \\& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \\& that no new inappropriate medications are initiated. After discharge, \\& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified."},{"id":"FG001","title":"Usual Care","description":"Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"52"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"47"},{"groupId":"FG001","numSubjects":"51"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Medical Condition","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Intervention Bundle (Behavioral Activation + Medication Optimization)","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.\n* Medications will be reviewed \\& optimized by a team of interventionists including a psychiatrist, pharmacologist, \\& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \\& that no new inappropriate medications are initiated. After discharge, \\& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified."},{"id":"BG001","title":"Usual Care","description":"Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"100"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"67.6","spread":"6.2"},{"groupId":"BG001","value":"66.9","spread":"6.6"},{"groupId":"BG002","value":"67.3","spread":"6.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"84"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"16"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"100"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"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":"8"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"15"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"85"}]},{"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":"52"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"100"}]}]}]}]},"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.\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":"Intervention Bundle (Behavioral Activation + Medication Optimization)","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.\n* Medications will be reviewed \\& optimized by a team of interventionists including a psychiatrist, pharmacologist, \\& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \\& that no new inappropriate medications are initiated. After discharge, \\& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified."},{"id":"OG001","title":"Usual Care","description":"Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults."},{"id":"OG002","title":"Total","description":"This includes participants in the Intervention Bundle arm and in Usual Care arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"100"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"18.35","spread":"1.35"},{"groupId":"OG001","value":"16.67","spread":"1.52"},{"groupId":"OG002","value":"17.51","spread":"1.14"}]}]},{"title":"Month 1","categories":[{"measurements":[{"groupId":"OG000","value":"10.95","spread":"1.37"},{"groupId":"OG001","value":"12.52","spread":"1.53"},{"groupId":"OG002","value":"11.74","spread":"1.15"}]}]},{"title":"Month 3","categories":[{"measurements":[{"groupId":"OG000","value":"9.39","spread":"1.40"},{"groupId":"OG001","value":"12.65","spread":"1.52"},{"groupId":"OG002","value":"11.02","spread":"1.16"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"From randomization through completion of study (estimated to be 4-6 months).","eventGroups":[{"id":"EG000","title":"Intervention Bundle (Behavioral Activation + Medication Optimization)","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.\n* Medications will be reviewed \\& optimized by a team of interventionists including a psychiatrist, pharmacologist, \\& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \\& that no new inappropriate medications are initiated. After discharge, \\& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.","deathsNumAffected":2,"deathsNumAtRisk":53,"seriousNumAffected":0,"seriousNumAtRisk":53,"otherNumAffected":1,"otherNumAtRisk":53},{"id":"EG001","title":"Usual Care","description":"Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.","deathsNumAffected":1,"deathsNumAtRisk":52,"seriousNumAffected":0,"seriousNumAtRisk":52,"otherNumAffected":0,"otherNumAtRisk":52}],"otherEvents":[{"term":"Bump on the head due to a fall","organSystem":"Injury, poisoning and procedural complications","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53},{"groupId":"EG001","numAffected":0,"numAtRisk":52}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Benjamin D. Kozower, M.D, MPH","organization":"Washington University School of Medicine","email":"kozower@wustl.edu","phone":"314-362-8089"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2023-10-30","uploadDate":"2026-03-07T06:49","filename":"Prot_004.pdf","size":441841},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2025-05-31","uploadDate":"2025-06-04T10:27","filename":"SAP_003.pdf","size":278204},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2024-01-05","uploadDate":"2024-11-15T09:19","filename":"ICF_001.pdf","size":599279}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001008","term":"Anxiety Disorders"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]}},"hasResults":true}