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

NCT06207318 | Recruiting

• 1 other identifier: 202311210
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

ACT; CABG

Outcome Measures

Primary Outcomes (7)

• Theoretical Framework of Acceptability (TFA) questionnaire

  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.

  8 weeks

• Participant Satisfaction measure

  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.

  8 weeks

• Participant Adherence measure

  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.

  8 weeks

• Participant Enrollment

  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.

  Baseline

• Intervention Delivery

  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.

  8 weeks

• Completion of Study Procedures

  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.

  8 weeks

• Retention

  The investigators will assess retention rate by tracking the proportion of enrolled participants who complete all intervention sessions and study procedures.

  8 weeks

Secondary Outcomes (7)

• Patient Health Questionnaire (PHQ-9)

  8 weeks

• Generalized Anxiety Disorder Questionnaire (GAD-7)

  Baseline and 8 weeks

• Mental Health Continuum-Short Form (MHC-SF)

  Baseline and 8 weeks

• MacNew Heart Disease Health Related Quality of Life (HRQoL)

  Baseline and 8 weeks

• Comprehensive Assessment of Acceptance Commitment Therapy Processes (CompACT)-15

  Baseline and 8 weeks

Study Arms (2)

ACT Intervention group

EXPERIMENTAL

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.

Behavioral: Acceptance and commitment therapy

Control treatment as usual (TAU) group

NO 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.

Interventions

Acceptance and commitment therapy 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.

ACT Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Neovascularization, Pathologic

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sara J Diesel, MA

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara J Diesel, MA

CONTACT

810-965-4425; sara-diesel@uiowa.edu

Mark Vander Weg, PhD

CONTACT

319-467-1377; mark-vanderweg@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Surgeons, nurses, and other hospital staff involved in patient care will remain blind to psychological treatment condition to avoid potential biases. Laboratory staff processing blood samples for measuring inflammatory biomarkers will be blinded to treatment condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention study model will be a two-group, randomized controlled trial. The randomization scheme will follow a 4:1 ratio, with the majority of participants being randomized to the intervention group.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 16, 2024
• Study Start: February 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)