CPMH: Perioperative Mental Health in Orthopedic Surgery

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05697835

Collaborator

National Institute of Mental Health (NIMH) (NIH)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Surgery Older Adults Depression Anxiety	Behavioral: Behavioral activation Other: Medication optimzation Other: Care as usual	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Hybrid Type 1 effectiveness-implementation randomized controlled trial designHybrid Type 1 effectiveness-implementation randomized controlled trial design

Masking:

Double (Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral activation and medication optimization 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 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.
Other: Control (treatment as usual) 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 Care as usual, with written resources provided

Arm

Intervention/Treatment

Experimental: Behavioral activation and medication optimization

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

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.

Other: Control (treatment as usual)

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

Care as usual, with written resources provided

Outcome Measures

Primary Outcome Measures

PHQ-ADS [3 months post-operatively]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Ryan Calfee, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ryan Calfee, MD, Professor of Orthopaedic Surgery, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT05697835

Other Study ID Numbers:

202201cal

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ryan Calfee, MD, Professor of Orthopaedic Surgery, Washington University School of Medicine

Behavioral: Behavioral activation

Medication optimization

Care as usual

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Jan 26, 2023