Counseling + Medicine for Depression/Anxiety in Cardiac Surgery Patients

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist older adults undergoing heart surgery who also experience depression or anxiety. It will test a new combination of counseling and carefully adjusted medication to determine if it is more effective than the usual care provided to these patients. Participants in the experimental group will receive Behavioral Activation (a type of behavioral counseling) and medication checks both in the hospital and for three months after surgery. Individuals aged 60 or older, scheduled for major heart surgery, and exhibiting noticeable symptoms of depression or anxiety may be well-suited for this study. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance care for future patients.

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 prior data suggests that this bundled intervention is safe for cardiac surgery patients?

Research has shown that behavioral activation is generally safe for people with depression. One study found that only 3.7% of participants in the behavioral activation group experienced more suicidal thoughts, compared to 7.4% in the usual care group, suggesting it is well-tolerated.

Medication optimization involves adjusting medicines to better treat depression and anxiety. People undergoing heart surgery may face medication issues due to other health problems and complex treatment plans. This approach aims to reduce these issues by using medicines more effectively.

Overall, both behavioral activation and medication optimization have demonstrated a good safety record based on past research. The goal is to improve mental health without causing major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of behavioral activation and medication optimization for treating depression and anxiety in cardiac surgery patients because it takes a comprehensive approach. Unlike the standard treatments, which often focus solely on medication, this approach integrates regular, personalized behavioral therapy sessions that start before surgery and continue postoperatively. Additionally, the treatment includes a careful review and adjustment of medications to reduce the use of brain-toxic drugs and ensure optimal dosing, enhancing both safety and effectiveness. This dual approach not only targets mental health more holistically but also aims to maintain improvements through close coordination with the patient's care team, offering a more tailored and potentially more effective strategy for this specific patient group.

What evidence suggests that this trial's treatments could be effective for depression and anxiety in cardiac surgery patients?

Research has shown that behavioral activation therapy, which participants in this trial may receive, can significantly reduce depression symptoms. Some studies have found nearly a 50% reduction after three and six months. This therapy also alleviates anxiety and can enhance overall mental health for individuals with heart conditions. Additionally, medication optimization, another treatment option in this trial, involves adjusting mental health medications to find the best combination and reduce harmful ones. This approach has improved mental health in surgical patients. Together, these methods aim to lift mood and reduce anxiety for those undergoing heart surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/circ.150.suppl_1.4137441

Abstract 4137441: Online Cognitive Behavioral Therapy ... Notable findings included significant reductions in depressive symptoms (Cohen's d = 0.70; p = 0.04), cardiac anxiety (Cohen's d = 1.53; p < ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8613762/

Effectiveness of cognitive behavioral therapy-based ... Our findings suggest that CBT-based interventions were effective in reducing depression, anxiety, stress symptoms, and body mass index levels.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4691441/

Cognitive behavioral therapy for depression improves pain ... A depression-focused CBT intervention yields benefits in other common postoperative problems, specifically improved perceived control and decreased pain.

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06457-w

The role of CBT in enhancing health outcomes in coronary ... The findings highlighted that CBT led to improvements in anxiety and depression symptoms, as well as reduced hospital stays, lowered ...

5. hcplive.com hcplive.com/view/behavioral-activation-therapy-treats-depression-patients-heart-failure

Behavioral Activation Therapy Treats Depression in ... Both participants in the behavioral activation therapy and medication experienced nearly a 50% reduction in depressive symptoms at months 3, 6, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021889/

Efficacy and safety of behavioural activation on depression ... Increased suicidal ideation affected 3.7% of the behavioural activation group and 7.4% of the enhanced usual care group. Unexpected physical health-related ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04877197

Behavioral Activation Delivered Via Home-based ... The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in improving ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05575128

Behavioral Activation and Medication Optimization In Older ... Behavioral activation (BA) will begin perioperatively and will span across 3 months postoperatively, with sessions approximately weekly or biweekly, depending ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3418911/

Depression, anxiety, and cardiac morbidity outcomes after ... Recent evidence suggests that both depression and anxiety increase the risk for mortality and morbidity after CABG surgery independent of medical factors.

10. withpower.com withpower.com/trial/phase-3-cardiovascular-diseases-2022-c99c7

Behavioral Activation Teletherapy for Cardiovascular ... Behavioral Activation Therapy has been shown to be effective in treating depression and anxiety, which are often linked to cardiovascular health. Studies have ...