Counseling + Medicine for Depression/Anxiety in Cardiac Surgery Patients

Overseen By Eric Lenze, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Severe cognitive impairment, Acutely suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

102 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 11 12}

Research Team

Simon Haroutounian, PhD, MSc

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Control (treatment as usual) Experimental Treatment 1 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 optimization Experimental Treatment 2 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.

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

Approved in United States as Behavioral Activation Therapy for:

• Depression
• Anxiety in older adults undergoing cardiac procedures

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Approved in European Union as Behavioral Activation Therapy for:

• Depression
• Anxiety

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative and long-term development of anxiety and depression in CABG patients. Korbmacher, B., Ulbrich, S., Dalyanoglu, H., et al.[2015]

In a study of 50 coronary artery bypass surgery patients, those who received hypnotherapeutic ego strengthening (HES) showed significant reductions in anxiety and depression both at discharge and 6 weeks later, compared to a control group.

The findings suggest that hypnotherapy could be a beneficial intervention for managing psychological distress in cardiac patients, although the results may not be applicable to all patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypnotherapeutic ego strengthening with male South African coronary artery bypass patients. de Klerk, JE., du Plessis, WF., Steyn, HS., et al.[2009]

Depression significantly increases the risk of major cardiovascular complications and neuropsychological issues after cardiac surgery, highlighting the need for awareness among healthcare providers.

The review suggests that understanding the mechanisms by which depression affects heart disease could improve patient outcomes, and it calls for more research on effective interventions for managing depression in cardiac surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological depression and cardiac surgery: a comprehensive review. Tully, PJ.[2021]

A randomized controlled trial is being set up to evaluate the effectiveness of behavioral activation treatments for depression and anxiety in 60 individuals with moderate to severe traumatic brain injury (TBI), at least 6 months post-injury.

The trial will compare an 8-session behavioral activation program, which includes both in-person and phone sessions, against a single session followed by 8 weeks of text message reminders, aiming to improve mood and activity levels in participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Activation Augmented With Mobile Technology for Depression and Anxiety in Chronic Moderate-Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial. Hart, T., Rabinowitz, A., Vaccaro, M., et al.[2022]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

Behavioral activation (BA) is an effective treatment for depression that focuses on increasing positive reinforcement in the environment to promote healthy behaviors and reduce avoidance.

BA can be integrated with other cognitive-behavioral strategies, making it versatile for various clinical populations and settings, highlighting its potential for broader application in treating emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. Farchione, TJ., Boswell, JF., Wilner, JG.[2019]

Behavioral activation (BA) was effective in reducing symptoms of depression in a preliminary study involving 20 older adults over 5 weeks, indicating its potential as a treatment for vulnerable populations.

Interestingly, the specific types or amounts of activities (functional, pleasurable, or social) did not significantly correlate with symptom improvement, suggesting that simply engaging in activities to counter avoidance may be key to the treatment's effectiveness.

NCBI (Pubmed)

pubmed.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. Hershenberg, R., Paulson, D., Gros, DF., et al.[2015]

Depression affects 30-40% of patients after coronary artery bypass grafting (CABG), particularly among women, and if left untreated, it can persist for many years, negatively impacting recovery and increasing the risk of complications.

Postoperative depression is linked to poorer treatment responses, higher rates of relapse, increased readmissions, and greater mortality, highlighting the importance of early detection and treatment, which may include SSRIs and cognitive behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative depression in patients after coronary artery bypass grafting (CABG) - a review of the literature. Stanicki, P., Szarpak, J., Wieteska, M., et al.[2021]

Depression affects 30-40% of patients after coronary artery bypass grafting (CABG), particularly among women, and if left untreated, it can persist for many years, negatively impacting recovery and increasing the risk of complications.

Postoperative depression is linked to poorer treatment responses, higher rates of relapse, increased readmissions, and greater mortality, highlighting the importance of early detection and treatment, which may include SSRIs and cognitive behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative depression in patients after coronary artery bypass grafting (CABG) - a review of the literature. Stanicki, P., Szarpak, J., Wieteska, M., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Moderators of the effect of psychological interventions on depression and anxiety in cardiac surgery patients: A systematic review and meta-analysis. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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]

3. Germany pubmed.ncbi.nlm.nih.gov

Perioperative and long-term development of anxiety and depression in CABG patients. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Hypnotherapeutic ego strengthening with male South African coronary artery bypass patients. [2009]

5. France pubmed.ncbi.nlm.nih.gov

Psychological depression and cardiac surgery: a comprehensive review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Behavioral Activation Augmented With Mobile Technology for Depression and Anxiety in Chronic Moderate-Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. [2019]

10. United States pubmed.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]

11. Poland pubmed.ncbi.nlm.nih.gov

Postoperative depression in patients after coronary artery bypass grafting (CABG) - a review of the literature. [2021]

12. Poland pubmed.ncbi.nlm.nih.gov

Postoperative depression in patients after coronary artery bypass grafting (CABG) - a review of the literature. [2021]