Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Surgery, Older Adults, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Behavioral activation
* Other: Medication optimzation
* Other: Care as usual


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adults ≥ 60 years Scheduled major cardiac procedure PHQ-ADS ≥ 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 Previous participation in this study or CPMH feasibility study 202101103.

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
Interventional Model Description: Hybrid Type 1 effectiveness-implementation randomized controlled trial design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral activation and medication optimization<br>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. Medications 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. | 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 optimzation<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>|
| Other: Control (treatment as usual)<br>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. | Other: Care as usual<br>* Care as usual, with written resources provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-ADS | PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores will be compared between the two study arms 3 months after surgery. PHQ-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) | 3 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral activation, medication optimization, cardiac surgery, perioperative mental health