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

Not Applicable

Completed

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

Interventions: Behavioral: Behavioral Activation
Other: Medication Optimization

Registration Number: NCT05685511

Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 105

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Bundle (Behavioral Activation + Medication Optimization)	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.
Intervention Bundle (Behavioral Activation + Medication Optimization)	Behavioral Activation	* 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.

Primary Outcome Measures

Name	Time	Method
Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)	Baseline, 1-month follow-up, and 3-month follow-up	* 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.
Change in anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)	Baseline, 1-month follow-up, and 3-month follow-up	* 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.