NCT06207318 · University of Iowa
Acceptance and Commitment Therapy for Patients Undergoing Coronary Artery Bypass Graft Surgery
(ACT for CABG)
What this study is about
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.
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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.
Interventions
BEHAVIORAL
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.
Primary outcome measures
Theoretical Framework of Acceptability (TFA) questionnaire
Time frame: 8 weeks
The TFA is comprised of seven constructs: affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, and opportunity costs, and also includes an overall acceptability rating. The TFA can be used to generate a single acceptability score and/or to assess the unique domains of acceptability included in the model. Scale scores range from minimum values of 7, and maximum values of 35, with higher scores indicating higher acceptability.
Participant Satisfaction measure
Time frame: 8 weeks
Participants will answer five questions on a 5-point Likert-type scale (1 = not at all, 5 = extremely). Scale scores range from minimum values of 5, and maximum values of 25, with higher scores indicating higher satisfaction.
Participant Adherence measure
Time frame: 8 weeks
The extent to which participants adhere to the intervention will be assessed via a self-rated measure in which completion of between-session mindfulness and reflection exercises will be reported. Participants will answer four yes/no items. Scale scores range from minimum values of 0, and maximum values of 4, with higher scores indicating higher adherence.
Participant Enrollment
Time frame: Baseline
The number and percentage of patients undergoing CABG who are eligible for the study will be tracked as well as the number of participants enrolled in the study. These values will be used to determine the enrollment rate. Additionally, the investigators will track basic patient characteristics such that representativeness of the enrolled sample may be compared to all eligible patients who were approached.
Intervention Delivery
Time frame: 8 weeks
Treatment fidelity will be assessed via coder-rated evaluation of interventionist adherence to the manualized treatment protocol. The coder will be a licensed therapist with specific expertise in ACT therapeutic principles and psychotherapy. A randomly selected 20% of sessions will be assessed for treatment fidelity and intervention adherence.
Completion of Study Procedures
Time frame: 8 weeks
Completion of all psychological, acceptance, satisfaction, and adherence measures will also be assessed. This will include completion of the entire measure as well as per-item completion which will be recorded for each participant in order to quantify missing data. Attendance will be recorded by the interventionist at each session.
Retention
Time frame: 8 weeks
The investigators will assess retention rate by tracking the proportion of enrolled participants who complete all intervention sessions and study procedures.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Iowa City, Iowa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 8, 2025 · Source of record for eligibility and locations