Acceptance and Commitment Therapy for Coronary Artery Disease
(ACT for CABG Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Iowa
Must not be taking: Psychotropic medications
Disqualifiers: Life-threatening conditions, Suicidal ideation, others
No Placebo Group
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.
12345Is 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.
12467How 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.
89101112Eligibility 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.
+1 more
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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: ACT Intervention groupExperimental Treatment1 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) groupActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Iowa Hospitals and ClinicsIowa City, IA
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Who Is Running the Clinical Trial?
University of IowaLead Sponsor
References
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]Acceptance and commitment therapy (ACT) is an intervention focusing on altering how patients relate to their thoughts. This study aimed to investigate the effects of ACT on self-management ability and psychological resilience of young and middle-aged patients undergoing percutaneous transluminal coronary intervention (PCI) for primary myocardial infarction (MI).
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]Acceptance and Commitment Therapy (ACT) is a behavioral intervention demonstrating sustained improvements in anxiety in individuals with chronic anxiety and psychological distress. Because anxiety disorders are associated with the development of cardiovascular disease (CVD), we hypothesized that a novel 1-day ACT workshop would both lower anxiety and improve vascular function in persons with moderate/high anxiety.
The Effectiveness of Acceptance and Commitment Therapy on Quality of Life in a Patient with Myocardial Infarction: A Randomized Control Trial. [2020]Objective: Acceptance and commitment therapy (ACT) interventions increase psychological flexibility and improve mental health and quality of life in patients with myocardial infarction. Study design: A controlled clinical trial study was conducted to evaluate the efficacy of an ACT intervention in improving the quality of life in patients with MI in Isfahan, Iran. Method : The present controlled clinical trial with a pre and post-test design was conducted on a statistical population consisting of patients with MI admitted to hospitals in Isfahan (n = 60) who were selected through sequential sampling based on the study inclusion criteria and were randomly divided into an intervention and a control group (n1 = n2 = 30). The case group received 8 weekly 90-minute sessions of ACT and the control group received no interventions. The pretest-posttest design was administered in both groups using a demographic questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) designed to assess the health status of patients with heart failure in terms of quality of life. The data obtained were analyzed in SPSS-20 using descriptive statistics and the ANCOVA. Results: In this study, 2 general areas of quality of life, including physical and mental health, were examined in the patients. There was a significant increase in the quality of life and subscales of mental and physical health in the experimental group (p < 0.001). Conclusion: Considering the effectiveness of ACT in improving quality of life in these patients, this method of intervention can be used as a complementary therapy in health care centers to reduce the side-effects experienced by these patients.
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]Acceptance and commitment therapy (ACT) is an empirically supported transdiagnostic approach that involves mindfulness processes and behavior change processes for valued living.
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]Previous studies have demonstrated that acceptance and commitment therapy (ACT) is effective for depression and may be useful for complex transdiagnostic clients.
A pilot study of acceptance and commitment therapy for promotion of physical activity. [2022]Acceptance and commitment therapy (ACT) appears to have some promise as a method of promoting physical activity.
Effectiveness of group acceptance and commitment therapy in treating depression for acute stroke patients. [2023]To date, the effectiveness of acceptance and commitment therapy (ACT) for acute stroke patients has not been well recognized. The study aimed to discover the effectiveness of group-based ACT in treating depression for acute stroke patients.
Efficacy of Cognitive Behavior Therapy in Reducing Depression among Patients with Coronary Heart Disease: An Updated Systematic Review and Meta-Analysis of RCTs. [2023]The aim of this review is to identify the efficacy of cognitive behavior therapy (CBT) and the characteristics of CBT therapy that effectively improve depression among patients with coronary heart disease (CHD).
Group psychotherapy for patients with coronary heart disease. [2019]Group therapy with cardiac patients is a relatively new specialty. The field is supported by a substantial epidemiological and experimental literature demonstrating links between heart and mind. There are several clinical trials that have demonstrated less morbidity, improved quality of life, and, to some extent, lower mortality for patients who have received psychosocial intervention, generally group therapy, compared to control patients. Different theoretical orientations and a small number of clinical techniques have been developed to help cardiac patients make an adjustment to heart-healthy living. This article provides a brief review of the literature in cardiac psychology, suggestions for developing a psychotherapy practice specialty with cardiac patients, techniques for treating these patients, and conclusions by a psychologist-cardiologist team that has been active in this area for more than a decade.
Cognitive behaviour therapy for cardiovascular diseases. [2019]Cognitive behaviour therapy (CBT) is the main empirically evaluated from of psychological therapy. When applied to cardiovascular disease it can be directed at preventing the occurrence or recurrence of disease or at altering the psychological consequences of disease. Prevention can be achieved through the modification of behavioural risk factors (e.g. smoking, diet) or by attempting to directly modify the psychological processes involved in atherogenesis and thrombogenesis. Successful applications of CBT in cardiovascular disease are described, some the remaining problems indicated and new directions for research pointed out.
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]Clinically significant symptoms of depression and anxiety in coronary heart disease (CHD) patients are common and associated with adverse outcomes. Psychological treatments have shown limited effectiveness and more effective treatments have been requested. Attention training technique (ATT), a component of metacognitive therapy, can potentially be effective as a stand-alone treatment for anxiety and depression. In an open study, ATT delivered face-to-face in a group format was feasible and potentially effective for improving depression and anxiety symptoms in CHD patients. The next progressive step is to test the effectiveness of ATT in a randomized controlled trial. This paper describes the methodology of this trial.
Cardiac rehabilitation. [2013]Occupational therapy plays a significant role in helping patients with coronary artery disease move to restored health and function and in facilitating their change from states of crisis to adaptation. Treatment begun early and carried out both in group and individual sessions, addresses cardiac function and risk factors in all phases of daily activities with emphasis on managing stress. Activities of daily living groups particularly emphasize energy conservation techniques in both vocational and avocational pursuits. Staff also teach and encourage appropriate lifestyle modifications.