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Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures

Primary Purpose

Cardiac Surgery, Older Adults, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral activation
Medication optimzation
Care as usual
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery focused on measuring Behavioral activation, medication optimization, cardiac surgery, perioperative mental health

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University in St. LouisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Behavioral activation and medication optimization

Control (treatment as usual)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 7, 2022
Last Updated
February 10, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05575128
Brief Title
Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures
Official Title
Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Cardiac Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Older Adults, Depression, Anxiety
Keywords
Behavioral activation, medication optimization, cardiac surgery, perioperative mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Hybrid Type 1 effectiveness-implementation randomized controlled trial design
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral activation and medication optimization
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (treatment as usual)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral activation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Medication optimzation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Description
Care as usual, with written resources provided
Primary Outcome Measure Information:
Title
PHQ-ADS
Description
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)
Time Frame
3 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theresa Cordner, BS
Phone
3142737921
Email
cordnert@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Bess
Phone
3142860026
Email
caitlin.christy@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Haroutounian, PharmD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Haroutounian, PHD
Phone
314-286-1715
Email
harous@anest.wustl.edu
First Name & Middle Initial & Last Name & Degree
Theresa Cordner
Phone
3142737921
Email
cordnert@wustl.edu
First Name & Middle Initial & Last Name & Degree
Michael S Avidan, MBBCh
First Name & Middle Initial & Last Name & Degree
Kenneth Freedland, PhD
First Name & Middle Initial & Last Name & Degree
Eric Lenze, MD
First Name & Middle Initial & Last Name & Degree
Joanna Abraham, PhD
First Name & Middle Initial & Last Name & Degree
Katherine Holzer, PhD
First Name & Middle Initial & Last Name & Degree
F.Muhammad Masood, MD
First Name & Middle Initial & Last Name & Degree
Kunal Kotkar, MD
First Name & Middle Initial & Last Name & Degree
Thomas Kannampallil, PhD
First Name & Middle Initial & Last Name & Degree
J. Philip Miller, PhD
First Name & Middle Initial & Last Name & Degree
Ana Baumann, PhD
First Name & Middle Initial & Last Name & Degree
Bethany Pennington, PharmD

12. IPD Sharing Statement

Plan to Share IPD
No

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Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures

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