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Completed

NCT Number: NCT05697835

Perioperative Mental Health in Orthopedic Surgery

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.

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Key information

Conditions

Orthopedic Surgery Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Older Adults

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Care as usual

Other

Care as usual, with written resources provided

Primary outcomes

  1. PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale)

    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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: CPMH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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