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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2024-07-12

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Usual Care

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.

Group Type ACTIVE_COMPARATOR

Usual care resources

Intervention Type OTHER

List of resources that the patient can explore on their own

Intervention Bundle (Behavioral Activation + Medication Optimization)

* 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.

Group Type EXPERIMENTAL

Behavioral Activation

Intervention Type BEHAVIORAL

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

Medication Optimization

Intervention Type OTHER

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.

Interventions

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Behavioral Activation

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

Intervention Type BEHAVIORAL

Medication Optimization

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.

Intervention Type OTHER

Usual care resources

List of resources that the patient can explore on their own

Intervention Type OTHER

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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No