Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Older Adults
- Sponsor
- Washington University School of Medicine
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
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).
- •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.
Outcomes
Primary Outcomes
Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Time Frame: 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)
Time Frame: 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.