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

Coronary Artery Disease Clinical Trial

— ACT for CABG  

Official title:

Acceptance and Commitment Therapy for the Perioperative Period of Coronary Artery Bypass Graft Surgery: a Randomized Controlled Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207318
• Other study ID #: 202311210
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Sara J Diesel, MA
• Phone: 810-965-4425
• Email: sara-diesel[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Neovascularization, Pathologic
• Vascularization

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	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).	Baseline and 8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	interleukin 6 (IL-6)	Concentrations of IL-6 will be quantified as indicators of inflammatory processes using a commercially available enzyme-linked immunoassay (ELISA).	Baseline and 8 weeks
Secondary	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).	Baseline and 8 weeks