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

Trial Summary

What is the purpose of this trial?

Heart disease is the leading cause of death globally, accounting for 16% of the world's total deaths. The number of cases is expected to increase as our population ages. Heart disease also results in large economic burden. It costs the United States about $219 billion per year. Some patients have symptoms that aren't helped by drugs or other medical treatments. These patients will need a surgery that is called cardiac artery bypass graft (CABG) surgery. CABG helps to improve chest pain which is one of the most common complaints of heart disease, and has life-prolonging potential. A limitation of CABG is that it results in increased inflammation. These patients also report high levels of anxiety and depression. Depression and anxiety in the several days surrounding surgery are related to several important things. These include worse health outcomes, worse quality of life, increased risk of death, and increased health care cost. Acceptance and Commitment Therapy (ACT) is a kind of therapy. ACT is adaptable, easy to access, and effective in brief formats. ACT has been gaining evidence for its use in many patient samples. Few studies have used ACT with heart disease patients. No known studies currently exist that have used ACT within the few days surrounding CABG surgery. To address this need, the investigators will conduct a two-arm feasibility randomized control trial (RCT). Patients will be randomized to one of two groups. The first group will complete a brief, 2-session telehealth ACT intervention. The second group will be a control group. The control will consist of treatment as usual. The investigators will evaluate the feasibility of this brief ACT intervention delivered in the peri-operative period. The investigators will also examine preliminary efficacy of the ACT intervention. The investigators will examine anxiety, depression, psychological inflexibility, well-being, and cardiovascular health-related quality of life. The investigators will also examine the intervention's impact on inflammation by measuring two inflammatory markers. The results from this study will also lay the groundwork for larger or multiple site RCT studies.

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 data supports the effectiveness of the treatment Acceptance and Commitment Therapy for Coronary Artery Disease?

Research shows that Acceptance and Commitment Therapy (ACT) can improve mental health and quality of life in patients with heart conditions like myocardial infarction (heart attack). It also helps reduce anxiety, which is linked to heart disease, suggesting it could be beneficial for coronary artery disease. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for humans?

Acceptance and Commitment Therapy (ACT) has been used safely in various studies for conditions like anxiety, depression, and promoting physical activity, with no significant safety concerns reported. ^{1 2 4 6 7}

How is Acceptance and Commitment Therapy (ACT) different from other treatments for coronary artery disease?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping patients accept their thoughts and feelings rather than trying to change them, which is different from Cognitive Behavior Therapy (CBT) that aims to modify thought patterns. ACT encourages patients to commit to actions that align with their values, potentially improving psychological well-being and quality of life for those with coronary artery disease. ^{8 9 10 11 12}

Research Team

Sara J Diesel, MA

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. United States 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. [2023]

3. Iran 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. [2020]

4. Canada 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. [2022]

5. United States 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. [2018]

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

A pilot study of acceptance and commitment therapy for promotion of physical activity. [2022]

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

Effectiveness of group acceptance and commitment therapy in treating depression for acute stroke patients. [2023]

8. Switzerland 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Group psychotherapy for patients with coronary heart disease. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy for cardiovascular diseases. [2019]

11. Switzerland 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. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation. [2013]