Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures

Depression Clinical Trial

Official title:

Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Cardiac Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575128
• Other study ID #: 202209033
• Secondary ID: P50MH122351
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Theresa Cordner, BS
• Phone: 3142737921
• Email: cordnert[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing cardiac surgery (compared with usual care), while examining implementation outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion criteria:

• Adults = 60 years

• Scheduled major cardiac procedure

• PHQ-ADS = 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

• Previous participation in this study or CPMH feasibility study 202101103.

Related Conditions & MeSH terms

• Anxiety
• Cardiac Surgery
• Depression
• 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 optimzation
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.
• Care as usual
Care as usual, with written resources provided

Locations

Country	Name	City	State
United States	Washington University in St. Louis	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	PHQ-ADS	PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores will be compared between the two study arms 3 months after surgery.; PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety)	3 months post-operatively