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NCT05685511
Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
Conditions: Older Adults, Anxiety, Depression, Major Surgical Resection of a Thoracic Malignancy, Major Surgical Resection of an Abdominal Malignancy
Sex: All
Ages: 60 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: Washington University School of Medicine
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Pre-screening:To 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).Screening:Adults age ≥60 yearsScheduled major thoracic or abdominal surgery for suspected or confirmed malignancyPHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10 indicating clinically significant depression or anxiety symptoms.Exclusion Criteria:Barrier to communication (Unable to read, speak, and understand English)Severe cognitive impairment screened by the SBT (Short Blessed Test) >10Acutely suicidalConsidered ineligible per the discretion of the oncologic surgeon or study PIPrevious participation in this study or another CPMH study of the intervention bundle or its feasibility.
Source: ClinicalTrials.gov (NCT05685511). StuddyBuddy aggregates publicly available trial information.