102 Participants Needed

Counseling + Medicine for Depression/Anxiety in Cardiac Surgery Patients

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TC
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Michael S Avidan, MBBch profile photo
Eric Lenze, MD profile photo
Overseen ByEric Lenze, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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 cardiac surgery (compared with usual care), while examining implementation outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the combination of counseling and medicine safe for humans?

Behavioral activation (BA), a component of the treatment, is generally considered safe and has been used effectively for depression and related conditions in various populations, including those with chronic health issues.12345

How is Behavioral Activation Therapy different from other treatments for depression and anxiety in cardiac surgery patients?

Behavioral Activation Therapy is unique because it focuses on helping patients engage in activities that improve their mood, rather than primarily using medication or traditional talk therapy. This approach is particularly beneficial for cardiac surgery patients as it can be tailored to their physical recovery process, encouraging gradual re-engagement with life activities that can enhance both mental and physical health.678910

What data supports the effectiveness of this treatment for depression and anxiety in cardiac surgery patients?

Research shows that psychological interventions, like those in the study, can reduce depression and anxiety in cardiac surgery patients, especially when delivered by trained professionals and after surgery. Additionally, hypnotherapy has been found to significantly reduce anxiety and depression in similar patient groups.68101112

Who Is on the Research Team?

SH

Simon Haroutounian, PhD, MSc

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 60 years old or older.
I am scheduled for a major heart surgery.
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
Previous participation in this study or CPMH feasibility study 202101103.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Behavioral activation and medication optimization begin perioperatively

1 week
In-hospital visits

Postoperative Treatment

Behavioral activation and medication optimization continue for 3 months postoperatively

12 weeks
Weekly or biweekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Behavioral Activation
  • Medication Optimization
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Control (treatment as usual)Experimental Treatment1 Intervention
Group II: Behavioral activation and medication optimizationExperimental Treatment2 Interventions

Behavioral Activation is already approved in United States, China, European Union for the following indications:

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Approved in United States as Behavioral Activation Therapy for:
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Approved in China as Behavioral Activation Therapy for:
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Approved in European Union as Behavioral Activation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

Psychological interventions for cardiac surgery patients significantly reduce depression and anxiety, especially when delivered post-surgery by trained professionals and over longer durations, as shown in a systematic review of 24 studies involving 2718 participants.
Specific interventions were more effective for certain patient groups: depression was more effectively reduced in coronary artery bypass graft patients, while anxiety was more effectively reduced in patients with implantable cardioverter defibrillators.
Moderators of the effect of psychological interventions on depression and anxiety in cardiac surgery patients: A systematic review and meta-analysis.Protogerou, C., Fleeman, N., Dwan, K., et al.[2018]
An exercise and education-based rehabilitation program for 88 patients after coronary artery bypass graft (CABG) surgery led to significant reductions in anxiety and depression levels at 12 weeks and 6 months, but not at 12 months, indicating a need for ongoing support.
The study highlights the importance of directly addressing anxiety and depression in cardiac rehabilitation, suggesting that more psychologically-focused programs may be necessary for long-term mental health improvement.
The effects of physical exercise training and cardiac education on levels of anxiety and depression in the rehabilitation of coronary artery bypass graft patients.O'Rourke, A., Lewin, B., Whitecross, S., et al.[2019]
In a study of 135 CABG patients, preoperative anxiety was found to be significantly elevated in 39.3% of patients, but decreased to 28.9% six months post-surgery, indicating a need for ongoing psychological support after surgery.
Depression scores increased postoperatively, with 28.0% of patients showing elevated depression six months after CABG, suggesting that even after surgery, patients may require therapeutic interventions to address mental health issues.
Perioperative and long-term development of anxiety and depression in CABG patients.Korbmacher, B., Ulbrich, S., Dalyanoglu, H., et al.[2015]

Citations

Moderators of the effect of psychological interventions on depression and anxiety in cardiac surgery patients: A systematic review and meta-analysis. [2018]
The effects of physical exercise training and cardiac education on levels of anxiety and depression in the rehabilitation of coronary artery bypass graft patients. [2019]
Perioperative and long-term development of anxiety and depression in CABG patients. [2015]
Hypnotherapeutic ego strengthening with male South African coronary artery bypass patients. [2009]
Psychological depression and cardiac surgery: a comprehensive review. [2021]
Behavioral Activation Augmented With Mobile Technology for Depression and Anxiety in Chronic Moderate-Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial. [2022]
Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]
A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]
Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Does Amount and Type of Activity Matter in Behavioral Activation? A Preliminary Investigation of the Relationship between Pleasant, Functional, and Social Activities and Outcome. [2015]
Postoperative depression in patients after coronary artery bypass grafting (CABG) - a review of the literature. [2021]
Postoperative depression in patients after coronary artery bypass grafting (CABG) - a review of the literature. [2021]
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