Perioperative Mental Health in Orthopedic Surgery
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT05697835
- Status
- Completed
Conditions
- Anxiety
- Depression
- Older Adults
- Orthopedic Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral activation — BEHAVIORALThe 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 — OTHERMedication 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 — OTHERCare as usual, with written resources provided
Study Details
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.
Key Dates
- Start date
- Feb 27, 2023
- Status verified
- Mar 2026
- Primary completion
- Mar 19, 2025
- Completion
- Mar 19, 2025
Study Design
- Enrollment
- 116 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Behavioral activation and medication optimizationBehavioral 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.
- 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.
Primary Outcome Measure
PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) [ Time Frame: Baseline and 3 months post-operatively ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | - |
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