Acceptance and Commitment Therapy for Patients Undergoing Coronary Artery Bypass Graft Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceptance and commitment therapy.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Vascularization. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acceptance and Commitment Therapy for the Perioperative Period of Coronary Artery Bypass Graft Surgery: a Randomized Controlled Feasibility Trial
Overview
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]
- Participant Satisfaction measure [Time frame: 8 weeks]
- Participant Adherence measure [Time frame: 8 weeks]
- Participant Enrollment [Time frame: Baseline]
- Intervention Delivery [Time frame: 8 weeks]
- Completion of Study Procedures [Time frame: 8 weeks]
- Retention [Time frame: 8 weeks]
Secondary outcome measures (7)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Iowa Hospitals and Clinics — Iowa City
Identifiers
NCT: NCT06207318 · 202311210