{"protocolSection":{"identificationModule":{"nctId":"NCT05110690","orgStudyIdInfo":{"id":"202101103"},"secondaryIdInfos":[{"id":"1P50MH122351","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1P50MH122351"}],"organization":{"fullName":"Washington University School of Medicine","class":"OTHER"},"briefTitle":"Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study","officialTitle":"Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study"},"statusModule":{"statusVerifiedDate":"2023-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-11-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-12-22","type":"ACTUAL"},"completionDateStruct":{"date":"2022-12-22","type":"ACTUAL"},"studyFirstSubmitDate":"2021-10-18","studyFirstSubmitQcDate":"2021-11-02","studyFirstPostDateStruct":{"date":"2021-11-08","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-11-03","resultsFirstSubmitQcDate":"2023-11-29","resultsFirstPostDateStruct":{"date":"2023-12-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-11-29","lastUpdatePostDateStruct":{"date":"2023-12-18","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":"Inadequate management of preoperative mental health disorders often contributes to poor postoperative outcomes, including increased rates of readmission, delirium, falls, and mortality. However, very little work has been done to improve perioperative mental health. In particular, there have been limited systematic efforts that identify evidence-based behavioral and pharmacological strategies that were originally developed for depression and anxiety in otherwise medically well psychiatric patients. A mental health intervention bundle, composed of behavioral and pharmacological strategies, can mitigate anxiety and depression symptoms during the perioperative period. However, lacking is conclusive evidence on effectiveness of such an intervention bundle focused on the delivery of perioperative mental health care in older surgical patients. Towards this end, the investigators will develop and test an intervention bundle that encompasses: (1) behavioral activation, and (2) medication optimization.","detailedDescription":"The proposed research is relevant to public health because the prevalence of undertreated depression/anxiety in older adults coupled with the increasing number of surgeries performed in this population are creating a crucial need for the integration of mental health interventions into critical periods, such as the perioperative period. Thus, the proposed research is relevant to the mission of the NIMH to transform the treatment of mental illnesses through clinical research, paving the way for prevention, recovery, and cure."},"conditionsModule":{"conditions":["Older Adults","Anxiety","Depression","Cardiac Surgery","Orthopedic Surgery","Major Surgical Resection of a Thoracic Malignancy","Major Surgical Resection of an Abdominal Malignancy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Patient Participants","type":"EXPERIMENTAL","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \\& health condition.\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":["Patient Participants"]},{"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":["Patient Participants"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants","timeFrame":"Through completion of the study (13 months and 5 days)"},{"measure":"Reach of the Intervention Bundle as Measured by the Number of Participants Who Completed the Intervention Out of the Participants Who Agreed to Participate in the Study","timeFrame":"Through completion of the study (13 months and 5 days)"}],"secondaryOutcomes":[{"measure":"Completeness of Planned Primary Outcome Data Collection at Specified Timepoints as Measured by the Number of Participants Who Completed 100% of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)","timeFrame":"Baseline, 1 month, and 3 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria Patient Participants\n\n* Age ≥60 years on the day of surgery;\n* Scheduled major orthopedic surgery, or major surgical resection of a thoracic or abdominal malignancy, or major cardiac procedure;\n* Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10\n\nExclusion Criteria Patient Participants\n\n* Estimated life expectancy \\< 12 months;\n* Unable to read, speak, and understand English;\n* Current alcohol or other substance abuse;\n* Severe cognitive impairment screened by the SBT (Short Blessed Test) \\>10;\n* Acutely suicidal","healthyVolunteers":false,"sex":"ALL","minimumAge":"60 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Michael Avidan, MBBCh, FCASA","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":"37891574","type":"DERIVED","citation":"Abraham J, Meng A, Baumann A, Holzer KJ, Lenard E, Freedland KE, Lenze EJ, Avidan MS, Politi MC. A multi- and mixed-method adaptation study of a patient-centered perioperative mental health intervention bundle. BMC Health Serv Res. 2023 Oct 27;23(1):1175. doi: 10.1186/s12913-023-10186-3."},{"pmid":"35998971","type":"DERIVED","citation":"Abraham J, Holzer KJ, Lenard EM, Freedland KE, Tellor Pennington BR, Wolfe RC, Cordner TA, Baumann AA, Politi M, Avidan MS, Lenze E. Perioperative mental health intervention bundle for older surgical patients: protocol for an intervention development and feasibility study. BMJ Open. 2022 Aug 23;12(8):e062398. doi: 10.1136/bmjopen-2022-062398."}],"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":"Due to the primary outcome measure, the number of participants eligible for consent and enrollment (n=29 participants) needs to be indicated in the participant flow.","groups":[{"id":"FG000","title":"Patient Participants","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \\& health condition.\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."}],"periods":[{"title":"Eligible for Consent and Enrollment","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"29"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Did not consent","reasons":[{"groupId":"FG000","numSubjects":"5"}]}]},{"title":"Enrolled","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]},{"title":"Started Intervention","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"23"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Ineligible due to canceled surgery","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]},{"title":"Completion of Intervention","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"23"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Patient Participants","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \\& health condition.\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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"23"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"68.0","spread":"4.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"15"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"19"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"19"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"23"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants","populationDescription":"One participant who signed consent, was considered eligible, and was enrolled to the study ended up having their surgery canceled and became ineligible for the study after enrollment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Through completion of the study (13 months and 5 days)","groups":[{"id":"OG000","title":"Patient Participants","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \\& health condition.\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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}]}]},{"type":"PRIMARY","title":"Reach of the Intervention Bundle as Measured by the Number of Participants Who Completed the Intervention Out of the Participants Who Agreed to Participate in the Study","populationDescription":"One participant who signed consent, was considered eligible, and was enrolled to the study ended up having their surgery canceled and became ineligible for the study after enrollment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Through completion of the study (13 months and 5 days)","groups":[{"id":"OG000","title":"Patient Participants","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \\& health condition.\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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}]}]},{"type":"SECONDARY","title":"Completeness of Planned Primary Outcome Data Collection at Specified Timepoints as Measured by the Number of Participants Who Completed 100% of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline, 1 month, and 3 months","groups":[{"id":"OG000","title":"Patient Participants","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \\& health condition.\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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}]},{"title":"1 month","categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}]},{"title":"3 months","categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"From start of intervention through completion of intervention (up to 3 months).","eventGroups":[{"id":"EG000","title":"Patient Participants","description":"* Behavioral activation (BA) will span across 3 months postoperatively \\& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \\& health condition.\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":1,"deathsNumAtRisk":23,"seriousNumAffected":0,"seriousNumAtRisk":23,"otherNumAffected":0,"otherNumAtRisk":23}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Michael Avidan, MBBCh, FCASA","organization":"Washington University School of Medicine","email":"avidanm@wustl.edu","phone":"314-273-4136"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2022-08-01","uploadDate":"2023-10-30T08:00","filename":"Prot_SAP_000.pdf","size":429496},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2023-10-26","uploadDate":"2023-10-30T08:00","filename":"ICF_001.pdf","size":347173}]}},"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}