Perioperative Mental Health in Orthopedic Surgery

Depression Clinical Trial

— CPMH  

Official title:

Behavioral Activation and Medication Optimization for Perioperative Mental Health in Orthopedic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697835
• Other study ID #: 202301070
• Secondary ID: P50MH122351
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: May 2023
• Source: Washington University School of Medicine
• Contact: Theresa Cordner, BS
• Phone: 314-273-7921
• 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 Orthopedic surgery (compared with usual care), while examining implementation outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Older Adults
• Orthopedic Surgery

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 School of Medicine	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