Anxiety & Depression Association of America

Perioperative Mental Health in Orthopedic Surgery

Purpose

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.

Conditions

Orthopedic Surgery
Older Adults
Depression
Anxiety

Eligibility

Eligible Ages: Over 60 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Hybrid Type 1 effectiveness-implementation randomized controlled trial design
Primary Purpose: Treatment
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.

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Washington University School of Medicine

Study Contact

Theresa Cordner, BS
314-273-7921
cordnert@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.