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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685511
• Other study ID #: 202212097
• Secondary ID: 1P50MH122351
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Benjamin D Kozower, M.D., MPH
• Phone: 314-362-8089
• Email: kozower[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Neoplasms
• Older Adults

Intervention

Behavioral:
• 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

Other:
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)	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.	Baseline, 1-month follow-up, and 3-month follow-up
Primary	Change in anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)	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.	Baseline, 1-month follow-up, and 3-month follow-up

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine