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

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

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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States