Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures

March 30, 2026 updated by: simon.haroutounian, Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University in St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral activation and medication optimization

Behavioral activation (BA) will begin perioperatively and will span across 3 months postoperatively, with sessions approximately weekly or biweekly, depending on patient preference & health condition.

Medications will be reviewed by a team of interventionists to minimize brain-toxic medications and optimize doses of antidepressants and other mental health medications. In-hospital and after discharge, the interventionists' role will include coordinating with the care teams to ensure that medication changes that were introduced preoperatively are maintained.
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.
Other: Control (treatment as usual)
Participants in control arm will continue care as usual. They will receive printed resources for supporting sleep hygiene, stress reduction, cognitive and mental health exercises, as well as community resources for older adults.
Other: Care as usual
Care as usual, with written resources provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ-ADS
Time Frame: baseline and 3 months post-operatively

Change in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively 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)
baseline and 3 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Simon Haroutounian, PharmD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2022

Primary Completion (Actual)

March 20, 2025

Study Completion (Actual)

March 29, 2025

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202209033
  • P50MH122351 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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