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Behavioral Activation + Medication for Depression & Anxiety in Aging Adults with Orthopedic Procedures (CPMH Trial)
N/A
Recruiting
Led By Ryan Calfee, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults ≥ 60 years
Scheduled primary hip or primary knee arthroplasty procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-operatively
Awards & highlights
CPMH Trial Summary
This trial will test a combined treatment of talk therapy & meds to reduce depression & anxiety in elderly orthopedic patients, compared to usual care.
Who is the study for?
This trial is for adults aged 60 or older who are about to have hip or knee replacement surgery and are experiencing noticeable symptoms of depression or anxiety. They must be able to communicate in English. Those with severe cognitive issues, a history of similar study participation, or acute suicidal thoughts cannot join.Check my eligibility
What is being tested?
The study is examining the impact of combining behavioral activation (a therapy focusing on increasing engagement in valued activities) with medication adjustments versus usual care on reducing depression and anxiety in aging adults during orthopedic surgery recovery.See study design
What are the potential side effects?
Potential side effects may include discomfort from engaging in new activities, changes in mood due to behavioral activation techniques, and reactions related to any changes made to medications as part of the optimization process.
CPMH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I am scheduled for a first-time hip or knee replacement surgery.
CPMH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PHQ-ADS
CPMH Trial Design
2Treatment groups
Experimental Treatment
Group I: Control (treatment as usual)Experimental Treatment1 Intervention
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.
Group II: Behavioral activation and medication optimizationExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral activation
2012
N/A
~100
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,869 Total Patients Enrolled
68 Trials studying Depression
23,279 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,777 Previous Clinical Trials
2,674,272 Total Patients Enrolled
665 Trials studying Depression
251,318 Patients Enrolled for Depression
Ryan Calfee, MDPrincipal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
455 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60 years old or older.I am scheduled for a first-time hip or knee replacement surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Control (treatment as usual)
- Group 2: Behavioral activation and medication optimization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for enrolment at this time?
"As indicated by the information posted on clinicaltrials.gov, this trial is no longer recruiting at this time as it was last updated January 14th 2023. Despite that fact, there are still 1366 other medical studies actively searching for volunteers."
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