Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery

Conditions
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Anxiety, Older Adults, Depression, Major Surgical Resection of a Thoracic Malignancy, Major Surgical Resection of an Abdominal Malignancy

Intervention / Treatment
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* Behavioral: Behavioral Activation
* Other: Medication Optimization


Participation Criteria
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Eligibility Criteria
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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 years Scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy PHQ-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) >10 Acutely suicidal Considered ineligible per the discretion of the oncologic surgeon or study PI Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br> | |
| Experimental: Intervention Bundle (Behavioral Activation + Medication Optimization)<br>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. 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. | Behavioral: Behavioral Activation<br>* 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<br>Other: Medication Optimization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) | 9 item questionnaire with answers ranging from 0=not at all to 3=nearly every day. Scores represent: 0-5=mild, 6-10=moderate, 11-15=moderately severe, and 16-20=severe depression. | Baseline, 1-month follow-up, and 3-month follow-up | 
| Change in anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) | 7 item questionnaire with answers ranging from 0=not at all to 3=nearly every day. Total score for the seven items ranges from 0 to 21. Scores 0-5=mild anxiety, 6-10=moderate anxiety, 11-15=moderately severe anxiety, and 15-21=severe anxiety. | Baseline, 1-month follow-up, and 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral activation, medication optimization, thoracic surgery, oncologic surgery, perioperative mental health