Clinical trial NCT06207318: Acceptance and Commitment Therapy for Patients Undergoing Coronary Artery Bypass Graft Surgery
Official title: Acceptance and Commitment Therapy for the Perioperative Period of Coronary Artery Bypass Graft Surgery: a Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Vascularization
Keywords: ACT
CABG
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Theoretical Framework of Acceptability (TFA) questionnaire
timeFrame: 8 weeks
measure: Participant Satisfaction measure
timeFrame: 8 weeks
measure: Participant Adherence measure
timeFrame: 8 weeks
measure: Participant Enrollment
timeFrame: Baseline
measure: Intervention Delivery
timeFrame: 8 weeks
measure: Completion of Study Procedures
timeFrame: 8 weeks
measure: Retention
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 8 weeks
measure: Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Baseline and 8 weeks
measure: Mental Health Continuum-Short Form (MHC-SF)
timeFrame: Baseline and 8 weeks
measure: MacNew Heart Disease Health Related Quality of Life (HRQoL)
timeFrame: Baseline and 8 weeks
measure: Comprehensive Assessment of Acceptance Commitment Therapy Processes (CompACT)-15
timeFrame: Baseline and 8 weeks
measure: interleukin 6 (IL-6)
timeFrame: Baseline and 8 weeks
measure: high sensitivity c-reactive protein (hs-CRP)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Sara J Diesel, MA
role: PRINCIPAL_INVESTIGATOR
References: