Coronary Artery DiseaseACT for CABGNCT06207318
Acceptance and Commitment Therapy for Patients Undergoing Coronary Artery Bypass Graft Surgery
A study testing Acceptance and commitment therapy in people with Coronary Artery Disease and Vascularization, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Vascularization
- What is being tested?
- Acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Sara J Diesel, M.A., 3194673026, sara-diesel@uiowa.edu
About this study
Official title: Acceptance and Commitment Therapy for the Perioperative Period of Coronary Artery Bypass Graft Surgery: a Randomized Controlled Feasibility 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.
- Conditions
- Coronary Artery Disease, Vascularization
- Being tested
- Acceptance and commitment therapy
- Keywords
- ACT, CABG
- Medical subject headings
- Coronary Artery Disease, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Retention
The investigators will assess retention rate by tracking the proportion of enrolled participants who complete all intervention sessions and study procedures.
Measured: 8 weeks
Secondary outcomes (7)
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a self-administered focused measure of depression based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria that is utilized for screening, diagnostic, and treatment monitoring purposes. The measure's nine items range from zero (not at all) to three (nearly every day). PHQ-9 scores greater than or equal to five, 10, 15, and 20 out of 27 represent mild, moderate, moderately severe, and severe depression, respectively.
Measured: 8 weeks
Generalized Anxiety Disorder Questionnaire (GAD-7)
The Generalized Anxiety Disorder (GAD)-7 survey. The GAD-7 is a self-rated measure designed to screen, measure, and assess the severity of GAD. The seven items range from zero (not at all) to three (nearly every day). Scores greater than or equal to five, 10, and 15 out of 21 represent mild, moderate, and severe anxiety, respectively.
Measured: Baseline and 8 weeks
Mental Health Continuum-Short Form (MHC-SF)
The Mental Health Continuum-Short Form (MHC-SF) is a 14-item scale that is comprised of three subscales: emotional well-being (three items), psychological well-being (six items), and social well-being (five items). Each item measures a distinct dimension of these subscales. The frequency in the past month of each aspect of well-being is rated on a six-point Likert scale (never, once or twice a month, about once a week, two to three times a week, almost every day, every day).
Measured: Baseline and 8 weeks
MacNew Heart Disease Health Related Quality of Life (HRQoL)
The MacNew Heart Disease HRQoL is a self-administered disease-specific questionnaire designed to measure HRQoL in patients with cardiac disease. The measure consists of 27 items that are categorized within three domains: emotional functioning (14 items), physical limitation (13 items), and social functioning (13 items), with 12 items falling into more than one domain. Five items inquire about symptoms such as angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The time frame for the MacNew is the previous two weeks. The measure provides both individual scores for each domain as well as a global HRQoL score. Scores range from one (poor HRQoL) to seven (high HRQoL) in each of the three domains.
Measured: Baseline and 8 weeks
Comprehensive Assessment of Acceptance Commitment Therapy Processes (CompACT)-15
The CompACT-15 assesses psychological inflexibility, experiential avoidance, and maladaptive coping that was adapted to fit the three-factor model of psychological flexibility more adequately and efficiently. This fifteen-item measure utilizes a seven-point Likert scale, ranging from one (strongly disagree) to seven (strongly agree). Scores range from 15 to 105, with higher scores indicating greater psychological flexibility. Three domains are captured within the measure including openness to experience, behavioral awareness, and valued action.
Measured: Baseline and 8 weeks
interleukin 6 (IL-6)
Concentrations of IL-6 will be quantified as indicators of inflammatory processes using a commercially available enzyme-linked immunoassay (ELISA).
Measured: Baseline and 8 weeks
high sensitivity c-reactive protein (hs-CRP)
Concentrations of hs-CRP will be quantified as indicators of inflammatory processes using a commercially available enzyme-linked immunoassay (ELISA).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start12 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara J. Diesel, University of Iowa
- Investigators
- Sara J Diesel, MA, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207318
- Sponsor's protocol ID
- 202311210
- Acronym
- ACT for CABG
- Status last verified
- Aug 2025
- First submitted
- 13 Dec 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for the Perioperative Period of Coronary Artery Bypass Graft Surgery: a Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT06207318
- Acronym / sponsor ID
- ACT for CABG / 202311210
- Conditions
- Coronary Artery Disease, Vascularization
- Keywords
- ACT, CABG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACT Intervention group | Experimental | Behavioral: Acceptance and commitment therapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapyThe 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. | Behavioural | ACT Intervention group |
Primary outcome
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.
7 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: 8 weeks
Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: Baseline and 8 weeks
Mental Health Continuum-Short Form (MHC-SF)
Time frame: Baseline and 8 weeks
MacNew Heart Disease Health Related Quality of Life (HRQoL)
Time frame: Baseline and 8 weeks
Comprehensive Assessment of Acceptance Commitment Therapy Processes (CompACT)-15
Time frame: Baseline and 8 weeks
interleukin 6 (IL-6)
Time frame: Baseline and 8 weeks
high sensitivity c-reactive protein (hs-CRP)
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara J Diesel, MA principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy in people with Coronary Artery Disease and Vascularization, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara J Diesel, MA (810-965-4425, sara-diesel@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theoretical Framework of Acceptability (TFA) questionnaire (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.