RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-12
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06207318

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * admission to the Heart and Vascular Center at University of Iowa Hospitals and Clinics (UIHC) for urgent or elective CABG
  2. * access to a personal phone or device with video or audio capabilities
  3. * ability to provide informed consent
  4. * English fluency.
  1. * life-threatening comorbid (noncardiac) medical condition(s)
  2. * active suicidal ideation or intent
  3. * psychotropic medication use lasting less than four weeks
  4. * inability to provide informed consent and comply with study procedures
  5. * those undergoing repeat revascularization

Contacts and Locations

Study Contact

Sara J Diesel, MA
CONTACT
810-965-4425
sara-diesel@uiowa.edu
Mark Vander Weg, PhD
CONTACT
319-467-1377
mark-vanderweg@uiowa.edu

Principal Investigator

Sara J Diesel, MA
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: University of Iowa

  • Sara J Diesel, MA, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-02-12
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • ACT
  • CABG

Additional Relevant MeSH Terms

  • Coronary Artery Disease
  • Vascularization