Trial Outcomes & Findings for Perioperative Mental Health in Orthopedic Surgery (NCT NCT05697835)
NCT ID: NCT05697835
Last Updated: 2026-04-09
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
Baseline and 3 months post-operatively
Results posted on
2026-04-09
Participant Flow
1,113 orthopedic patients were assessed for eligibility, 501 did not meet inclusion criteria, 386 declined participation, and 110 were excluded for other reasons.
Participant milestones
| Measure |
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 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
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.
|
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.
Care as usual: Care as usual, with written resources provided
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
58
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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 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
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.
|
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.
Care as usual: Care as usual, with written resources provided
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Perioperative Mental Health in Orthopedic Surgery
Baseline characteristics by cohort
| Measure |
Behavioral Activation and Medication Optimization
n=50 Participants
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 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
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.
|
Control (Treatment as Usual)
n=54 Participants
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.
Care as usual: Care as usual, with written resources provided
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 6.4 • n=36 Participants
|
68.7 years
STANDARD_DEVIATION 5.4 • n=78 Participants
|
68.8 years
STANDARD_DEVIATION 5.9 • n=23 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=36 Participants
|
46 Participants
n=78 Participants
|
73 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=36 Participants
|
8 Participants
n=78 Participants
|
31 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=36 Participants
|
54 Participants
n=78 Participants
|
104 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=36 Participants
|
9 Participants
n=78 Participants
|
12 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=36 Participants
|
45 Participants
n=78 Participants
|
92 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=36 Participants
|
54 participants
n=78 Participants
|
104 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months post-operativelyChange 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)
Outcome measures
| Measure |
Behavioral Activation and Medication Optimization
n=50 Participants
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 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
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.
|
Control (Treatment as Usual)
n=54 Participants
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.
Care as usual: Care as usual, with written resources provided
|
|---|---|---|
|
PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale)
Baseline
|
16.84 Points
Standard Error 1.02
|
19.35 Points
Standard Error 1.10
|
|
PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale)
Month 1
|
11.26 Points
Standard Error 1.03
|
13.09 Points
Standard Error 1.10
|
|
PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale)
Month 3
|
9.08 Points
Standard Error 1.03
|
10.48 Points
Standard Error 1.12
|
Adverse Events
Behavioral Activation and Medication Optimization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (Treatment as Usual)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ryan Calfee, MD
Washinton University School of Medicine
Phone: 314-362-9369
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place