Acceptance and Commitment Therapy for Patients Undergoing Coronary Artery Bypass Graft Surgery

NCT ID: NCT06207318

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Coronary Artery Disease; Vascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ACT Intervention group

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 Type: EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type: BEHAVIORAL

The intervention will be based on Acceptance and Commitment Therapy (ACT). ACT is an empirically-based therapeutic approach that focuses on psychological flexibility, acceptance, and the reduction of experiential avoidance. It encourages individuals to change their relating to thoughts and experiences and act in accordance with their values.

Control treatment as usual (TAU) group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acceptance and commitment therapy

The intervention will be based on Acceptance and Commitment Therapy (ACT). ACT is an empirically-based therapeutic approach that focuses on psychological flexibility, acceptance, and the reduction of experiential avoidance. It encourages individuals to change their relating to thoughts and experiences and act in accordance with their values.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• admission to the Heart and Vascular Center at University of Iowa Hospitals and Clinics (UIHC) for urgent or elective CABG
• access to a personal phone or device with video or audio capabilities
• ability to provide informed consent
• English fluency.

Exclusion Criteria

• life-threatening comorbid (noncardiac) medical condition(s)
• active suicidal ideation or intent
• psychotropic medication use lasting less than four weeks
• inability to provide informed consent and comply with study procedures
• those undergoing repeat revascularization

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Sara J. Diesel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara J Diesel, MA

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara J Diesel, MA

Role: CONTACT

sara-diesel@uiowa.edu

810-965-4425

Mark Vander Weg, PhD

Role: CONTACT

mark-vanderweg@uiowa.edu

319-467-1377

Facility Contacts

Sara J Diesel, M.A.

Role: primary

sara-diesel@uiowa.edu

3194673026

Other Identifiers

202311210

Identifier Type: -

Identifier Source: org_study_id