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Counseling + Medicine for Depression/Anxiety in Cardiac Surgery Patients
N/A
Recruiting
Led By Simon Haroutounian, PharmD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-operatively
Awards & highlights
Study Summary
This trial will study how well combining counseling and medicine helps reduce depression/anxiety for elderly heart surgery patients vs. usual care.
Who is the study for?
This trial is for adults aged 60 or older who are about to have major heart surgery and are showing signs of depression or anxiety. They must be able to communicate in English and not have severe cognitive issues, acute suicidal thoughts, or previous participation in similar studies.Check my eligibility
What is being tested?
The study is looking at how well a combined approach of behavioral activation (a therapy focusing on increasing engagement in valued activities) and medication optimization works compared to usual care for reducing depression and anxiety symptoms in aging adults having cardiac surgery.See study design
What are the potential side effects?
Since the interventions include psychological therapy and adjustments to medications rather than new drugs, side effects may vary widely but could include discomfort from discussing personal issues during therapy sessions or changes in mood due to medication alterations.
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
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
1,935 Previous Clinical Trials
2,299,773 Total Patients Enrolled
12 Trials studying Anxiety
1,672 Patients Enrolled for Anxiety
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,175 Total Patients Enrolled
82 Trials studying Anxiety
39,000 Patients Enrolled for Anxiety
Simon Haroutounian, PharmDPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60 years old or older.I am scheduled for a major heart 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.
Anxiety Patient Testimony for trial: Trial Name: NCT05575128 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are enrolled in this experiment?
"Affirmative. Clinicaltrials.gov data verifies that this research initiative, which was first posted on November 5th 2022, is actively recruiting from 1 location and requires 100 participants in total."
Answered by AI
Is enrollment for this research trial open at the moment?
"Affirmative. The clinicaltrials.gov site indicates that recruitment for this study is still underway; it was first posted on November 5th 2022 and most recently updated on the 22nd of the same month. 100 participants need to be enrolled, at one location."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Colorado
Kentucky
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
3+
What site did they apply to?
Washington University in St. Louis
Why did patients apply to this trial?
I have alot depressoon. Serios problems de deprecion. The last 3 years my depression has gotten worse.
PatientReceived 1 prior treatment
I have been on Prozac and Valium, Xanax and nothing helps. I’ve tried three or more different medications and they didn’t work for me.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Do you cover travel expenses? How long are the visits and how often? Can they be virtual?
PatientReceived no prior treatments
I would have to travel and stay in st. Louis with a friend, so how long would this study take?
PatientReceived 2+ prior treatments
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