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

The Washington University

Status: Completed

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

Treatments: Behavioral: Behavioral Activation; Other: Usual care resources; Other: Medication Optimization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05685511

1P50MH122351 (U.S. NIH Grant/Contract)

202212097

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual care resources

Intervention Bundle (Behavioral Activation + Medication Optimization)

Experimental group

Description:

* 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.

Treatment:

Other: Medication Optimization

Behavioral: Behavioral Activation