Back to resultsPerioperative Mental Health in Orthopedic Surgery (CPMH)
Primary Purpose
Orthopedic 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
About this trial
This is an interventional treatment trial for Orthopedic Surgery focused on measuring Behavioral: Behavioral activation, Medication optimization, Care as usual
Eligibility Criteria
Inclusion criteria: Adults ≥ 60 years Scheduled primary hip or primary knee arthroplasty 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 another CPMH study of the intervention bundle or its feasibility.
Sites / Locations
- Washington University School of MedicineRecruiting
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
NCT ID
NCT05697835
First Posted
January 14, 2023
Last Updated
May 5, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05697835
Brief Title
Perioperative Mental Health in Orthopedic Surgery
Acronym
CPMH
Official Title
Behavioral Activation and Medication Optimization for Perioperative Mental Health in Orthopedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (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 Orthopedic 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
Orthopedic Surgery, Older Adults, Depression, Anxiety
Keywords
Behavioral: Behavioral activation, Medication optimization, Care as usual
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 primary hip or primary knee arthroplasty 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 another CPMH study of the intervention bundle or its feasibility.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theresa Cordner, BS
Phone
314-273-7921
Email
cordnert@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Bess
Phone
314-362-3561
Email
caitlin.christy@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Calfee, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
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
Theresa Cordner, BS
Phone
314-273-7921
Email
cordnert@wustl.edu
First Name & Middle Initial & Last Name & Degree
Caitlin Bess
Phone
314-286-0026
Email
caitlin.christy@wustl.edu
First Name & Middle Initial & Last Name & Degree
Ryan Calfee, MD
First Name & Middle Initial & Last Name & Degree
Simon Haroutounian, PhD
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
Thomas Kannampallil, PhD
First Name & Middle Initial & Last Name & Degree
J. Phillip Miller, PhD
First Name & Middle Initial & Last Name & Degree
Ana Baumann, PhD
First Name & Middle Initial & Last Name & Degree
Bethany Pennington,, PharmD
First Name & Middle Initial & Last Name & Degree
Kimberly Bartosiak, MD
First Name & Middle Initial & Last Name & Degree
Mary Politi, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Perioperative Mental Health in Orthopedic Surgery
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