Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures

NCT05575128 | Completed Results

• 2 other identifiers: 202209033P50MH122351
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery; Older Adults; Depression; Anxiety

Keywords

Behavioral activation; medication optimization; cardiac surgery; perioperative mental health

Outcome Measures

Primary Outcomes (1)

• PHQ-ADS

  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

Study Arms (2)

Behavioral activation and medication optimization

EXPERIMENTAL

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; Other: Medication optimzation

Control (treatment as usual)

OTHER

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

Interventions

Behavioral activation BEHAVIORAL

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

Behavioral activation and medication optimization

Medication optimzation OTHER

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.

Behavioral activation and medication optimization

Care as usual OTHER

Care as usual, with written resources provided

Control (treatment as usual)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 60 years
• Scheduled major cardiac procedure
• PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Holzer KJ, Bartosiak KA, Calfee RP, Hammill CW, Haroutounian S, Kozower BD, Cordner TA, Lenard EM, Freedland KE, Tellor Pennington BR, Wolfe RC, Miller JP, Politi MC, Zhang Y, Yingling MD, Baumann AA, Kannampallil T, Schweiger JA, McKinnon SL, Avidan MS, Lenze EJ, Abraham J. Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials. BMJ Open. 2024 Apr 3;14(4):e082656. doi: 10.1136/bmjopen-2023-082656.

  PMID: 38569683 DERIVED

• Pennington BRT, Holzer KJ, Fritz BA, Haroutounian S, Xu KY, Tedder A, Kronzer A, Avidan MS, Lenze EJ. Brain-Hazardous Medications and Potential Subadequate Antidepressant Dosing in Older Surgical Patients Receiving Home Antidepressants: An Observational Study of a Large US Health System. Anesth Analg. 2024 Jul 1;139(1):155-164. doi: 10.1213/ANE.0000000000006952. Epub 2024 Mar 20.

  PMID: 38507476 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Simon Haroutounian, PhD, Msc, Russell D and Mary B Shelden Professor of Anesthesiology
• Organization: Washington University School of Medicine

sharout@wustl.edu

314-286-1715

Study Officials

• Simon Haroutounian, PharmD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study staff responsible for administering ratings and collecting outcomes throughout the study are blinded. The investigator(s) are also blinded. This blinding is kept throughout the study until data collection is complete. At the end of the follow-up, the study coordinator will complete a blinding question to try to guess the arm to which each participant was allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof of Anesthesiology

Model Details: Hybrid Type 1 effectiveness-implementation randomized controlled trial design

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: November 5, 2022
• Primary Completion: March 20, 2025
• Study Completion: March 29, 2025
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)