Acceptance and Commitment Therapy for Coronary Artery Disease

(ACT for CABG Trial)

Overseen By Mark Vander Weg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must not be taking: Psychotropic medications

Disqualifiers: Life-threatening conditions, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Acceptance and Commitment Therapy (ACT) can improve well-being before and after coronary artery bypass grafting (CABG), a surgery for heart disease. ACT is a talk therapy that helps individuals accept difficult thoughts and feelings, commit to personal values, and make positive changes. The trial will compare two groups: one receiving brief ACT sessions via telehealth and the other receiving usual care. Participants must be scheduled for CABG surgery at the University of Iowa and have access to a phone or device with video capabilities. As an unphased trial, this study provides a unique opportunity to explore innovative therapy options that could enhance recovery and well-being.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants using psychotropic medications must have been on them for at least four weeks, suggesting that some medications may be continued.

What prior data suggests that Acceptance and Commitment Therapy is safe for heart disease patients?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally safe for patients. Studies have found that while ACT doesn't significantly alter short-term biological risk factors in heart disease patients, it causes no major side effects. This therapy helps improve mental health issues like anxiety and depression, which are important for heart disease patients. Although ACT appears promising, further research is needed to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for coronary artery disease because it offers a unique psychological approach to managing the condition. Unlike standard treatments that focus on medication, surgery, or lifestyle changes, ACT emphasizes psychological flexibility through mindfulness and value-based living. This therapy helps patients be present and open up emotionally, leading them to focus on what truly matters to them, which can enhance their recovery and overall well-being. By addressing mental health alongside physical health, ACT aims to improve post-surgical outcomes and patient satisfaction, offering a holistic approach that complements traditional medical interventions.

What evidence suggests that Acceptance and Commitment Therapy is effective for coronary artery disease?

Research has shown that Acceptance and Commitment Therapy (ACT) might help people become more flexible in their thinking, manage their emotions better, and take care of themselves. In this trial, participants in the ACT Intervention group will receive a two-session intervention focusing on personal values and behaviors that align with participant goals. For those with coronary artery disease, ACT has the potential to improve emotional and mental well-being. One study found that ACT did not produce different results in heart disease patients compared to regular care, indicating mixed outcomes in this area. However, ACT's ability to adapt and focus on what matters to each person could still be helpful, especially for managing anxiety and depression. More research is needed to confirm its effectiveness for heart health. ^{2 4 6 7 8}

Who Is on the Research Team?

Sara J Diesel, MA

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for patients with heart disease who are admitted to the UIHC for urgent or elective CABG surgery. Participants must have a phone or device capable of video or audio, be able to consent, and speak English fluently.

Inclusion Criteria

Access to a personal phone or device with video or audio capabilities

Ability to provide informed consent

I am admitted to UIHC for urgent or planned heart bypass surgery.

Exclusion Criteria

Active suicidal ideation or intent

I have been using psychotropic medication for less than 4 weeks.

I am able to understand and agree to the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Appointment

Participants attend a 1.5-hour preoperative appointment with the case-assigned cardiothoracic surgeon and a nurse practitioner.

1 day

1 visit (in-person)

Treatment

Participants in the ACT Intervention group receive a two-session telehealth ACT intervention, each session lasting 60-90 minutes.

1 week

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of anxiety, depression, and inflammation markers.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy

Trial Overview The study tests Acceptance and Commitment Therapy (ACT) delivered via telehealth in two sessions around the time of CABG surgery. It compares ACT's effects on anxiety, depression, well-being, and inflammation against usual treatment without ACT.

How Is the Trial Designed?

Group I: ACT Intervention group Experimental Treatment 1 Intervention

Participants in the ACT Intervention condition will receive a two-session intervention, with each session lasting 60-90 minutes. Intervention content will center around personal values and behaviors that align with participant goals and utilize the 'triflex' model of ACT, which indicates three core processes of psychological flexibility: be present, open up, and do what matters. Sessions will be facilitated by the PI, an advanced graduate student in the Clinical Science Ph.D. program at the University of Iowa trained in ACT psychotherapy and supervised by a licensed and highly experienced psychologist. Patients will receive a patient workbook and audio recordings of mindfulness exercises that mirror those completed during the session. The intervention will also focus on patients' health-related goals and objectives surrounding their surgery, and expectations for positive post-surgical functioning.

Group II: Control treatment as usual (TAU) group Active Control 1 Intervention

The control condition will consist of treatment as usual. This includes a 1.5-hour preoperative appointment with the case-assigned cardiothoracic surgeon and a nurse practitioner. Patients are provided with workbooks that include orientation to the hospital and lifestyle factors information, which includes diet, physical activity, and stress management recommendations.

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Published Research Related to This Trial

Cognitive Behaviour Therapy (CBT) is an effective psychological intervention for cardiovascular disease, focusing on preventing disease occurrence and addressing psychological impacts.

CBT can help modify behavioral risk factors like smoking and diet, as well as target psychological processes that contribute to heart disease, showing promise for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy for cardiovascular diseases. Johnston, DW.[2019]

Acceptance and Commitment Therapy (ACT) showed significant improvements in global mental health, depression, cognitive fusion, and values in complex clients treated by both psychologists and non-psychologists in a National Health Service setting.

The positive effects of ACT were partially maintained at a 3-month follow-up, indicating its potential long-term benefits, and outcomes were similar regardless of the therapist's professional background.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of Acceptance and Commitment Therapy Delivered by Psychologists and Non-Psychologists in an NHS Community Adult Mental Health Service: a Preliminary Analysis. Richardson, T., Bell, L., Bolderston, H., et al.[2018]

The ATT-CHD study is a randomized controlled trial designed to evaluate the effectiveness of Attention Training Technique (ATT) for reducing anxiety and depression symptoms in coronary heart disease patients, involving 64 participants split between ATT and a wait-list control group.

This study will be the first of its kind to assess group-based ATT in CHD patients, measuring not only psychological outcomes but also potential biological markers like C-Reactive Protein (CRP), which may provide insights into the relationship between psychological distress and physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention training technique delivered in groups as treatment for anxiety and depression in patients with coronary heart disease: study protocol for a waiting-list randomized controlled trial. Dammen, T., Tunheim, K., Munkhaugen, J., et al.[2023]

Occupational therapy is crucial for patients with coronary artery disease, aiding their recovery and adaptation by addressing cardiac function and risk factors through both group and individual sessions.

Early intervention focuses on managing stress and teaching energy conservation techniques, which helps patients integrate lifestyle modifications into their daily activities for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation. Bird, K., Phelps, S.[2013]

In a pilot study of 98 young and middle-aged patients undergoing PCI for myocardial infarction, those who received Acceptance and Commitment Therapy (ACT) showed significantly improved psychological resilience and self-management abilities compared to a control group receiving routine nursing.

Three months after the intervention, the ACT group had higher scores in both psychological resilience and self-management, indicating that ACT can effectively enhance these important skills in patients recovering from heart procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of acceptance and commitment therapy on self-management skills and psychological resilience of young and middle-aged patients underwent percutaneous transluminal coronary intervention for primary myocardial infarction: a pilot study. Cao, J., Sun, P., Zhang, L., et al.[2022]

A 1-day Acceptance and Commitment Therapy (ACT) workshop significantly reduced anxiety levels in 72 adults with moderate to high anxiety, as measured by the Beck Anxiety Inventory.

However, the workshop did not lead to improvements in vascular function or inflammatory markers, and was associated with an increase in carotid artery stiffness, suggesting that anxiety reduction did not translate into cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-day acceptance and commitment therapy (ACT) workshop improves anxiety but not vascular function or inflammation in adults with moderate to high anxiety levels in a randomized controlled trial. Fiedorowicz, JG., Dindo, L., Ajibewa, T., et al.[2023]

Group therapy for cardiac patients has been shown to reduce morbidity and improve quality of life, with some evidence suggesting it may also lower mortality rates compared to patients who do not receive psychosocial interventions.

The article reviews various clinical techniques and theoretical approaches developed to support cardiac patients in adjusting to heart-healthy living, highlighting the importance of integrating psychological care in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group psychotherapy for patients with coronary heart disease. Allan, R., Scheidt, S.[2019]

In a pilot study involving young adult females, those who participated in Acceptance and Commitment Therapy (ACT) showed a significant increase in physical activity compared to those who received an Education intervention.

The ACT intervention, which included mindfulness and values clarification techniques, suggests that this therapeutic approach can effectively promote short-term behavior change related to physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of acceptance and commitment therapy for promotion of physical activity. Butryn, ML., Forman, E., Hoffman, K., et al.[2022]

A randomized controlled trial involving 140 acute stroke patients demonstrated that group-based acceptance and commitment therapy (ACT) significantly reduced depression levels compared to a control group, with effects lasting up to 3 months after the intervention.

In addition to reducing depression, ACT also improved health-related quality of life, sleep quality, psychological flexibility, cognitive fusion, and confidence in the patients, highlighting its comprehensive benefits for mental health post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of group acceptance and commitment therapy in treating depression for acute stroke patients. Liu, YE., Lv, J., Sun, FZ., et al.[2023]

A controlled clinical trial involving 60 patients with myocardial infarction showed that Acceptance and Commitment Therapy (ACT) significantly improved both physical and mental health quality of life scores after 8 weekly sessions (p < 0.001).

The results suggest that ACT can be an effective complementary therapy for enhancing the quality of life in patients recovering from myocardial infarction, potentially reducing their psychological distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Acceptance and Commitment Therapy on Quality of Life in a Patient with Myocardial Infarction: A Randomized Control Trial. Ahmadi Ghahnaviyeh, L., Bagherian, B., Feizi, A., et al.[2020]

Internet-based Acceptance and Commitment Therapy (iACT) shows small effects in reducing depressive symptoms, anxiety, stress, psychological distress, and improving quality of life, based on a systematic review of 39 randomized controlled trials.

While iACT was effective compared to passive control groups, it did not show significant advantages over active control groups, indicating the need for further high-quality studies to compare its efficacy with other established therapies like cognitive behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Internet-Based Acceptance and Commitment Therapy for Depressive Symptoms, Anxiety, Stress, Psychological Distress, and Quality of Life: Systematic Review and Meta-analysis. Han, A., Kim, TH.[2022]

Cognitive behavior therapy (CBT) significantly reduces depression in patients with coronary heart disease (CHD), with a standardized mean difference of -0.37 based on a review of 14 randomized controlled trials.

Short-term follow-ups showed even greater efficacy, with a standardized mean difference of -0.46, indicating that both face-to-face and remote CBT approaches are effective in improving mental health outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Cognitive Behavior Therapy in Reducing Depression among Patients with Coronary Heart Disease: An Updated Systematic Review and Meta-Analysis of RCTs. Nuraeni, A., Suryani, S., Trisyani, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12346411/

Effectiveness of Acceptance and Commitment Therapy ... Results: The reviewed studies suggest that ACT may promote psychological flexibility, emotion regulation, and self-care behaviors in patients ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38866567/

Effects of a brief intervention based on Acceptance and ... This was a two-arm randomised controlled trial comparing a brief, manualised, ACT-based intervention with usual care (UC).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212144723000522

Effectiveness of Acceptance and Commitment Therapy on ... Acceptance and commitment therapy appears to be effective in improving outcomes. •. More randomized controlled trials are needed for cardiovascular diseases.

4. ijbmc.org ijbmc.org/index.php/ijbmc/article/view/704

Comparing the Effectiveness of Acceptance and ... This study aimed to compare the effectiveness of Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Cognitive Therapy (MBCT) on the life expectancy ...

5. 2minutemedicine.com 2minutemedicine.com/acceptance-and-commitment-therapy-not-associated-with-different-outcomes-in-patients-with-coronary-artery-disease/

Acceptance and commitment therapy not associated with ... Acceptance and commitment therapy not associated with different outcomes in patients with coronary artery disease | 2 Minute Medicine.

6. mdpi.com mdpi.com/2227-9032/13/15/1831

Effectiveness of Acceptance and Commitment Therapy ... Conclusions: While preliminary findings indicate that ACT shows promise in addressing psychological aspects of CVDs, the current evidence remains insufficient ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/14/6/e084070

Effects of a brief intervention based on Acceptance and ... The primary purpose of this study was to evaluate the efficacy of adding a brief ACT-based intervention to improve cardiac risk factors and psychological well- ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40805864/

Effectiveness of Acceptance and Commitment Therapy ... Conclusions: While preliminary findings indicate that ACT shows promise in addressing psychological aspects of CVDs, the current evidence ...