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Behavioural Intervention

Acceptance and Commitment Therapy for Coronary Artery Disease (ACT for CABG Trial)

N/A

Recruiting

Led By Sara J Diesel, MA

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admission to the Heart and Vascular Center at University of Iowa Hospitals and Clinics (UIHC) for urgent or elective CABG

Be older than 18 years old

Must not have

Inability to provide informed consent and comply with study procedures

Those undergoing repeat revascularization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the use of a brief therapy called Acceptance and Commitment Therapy (ACT) for patients undergoing cardiac artery bypass graft (CABG) surgery. Patients with heart disease who

Who is the study for?

This trial is for patients with heart disease who are admitted to the UIHC for urgent or elective CABG surgery. Participants must have a phone or device capable of video or audio, be able to consent, and speak English fluently.

What is being tested?

The study tests Acceptance and Commitment Therapy (ACT) delivered via telehealth in two sessions around the time of CABG surgery. It compares ACT's effects on anxiety, depression, well-being, and inflammation against usual treatment without ACT.

What are the potential side effects?

Since ACT is a type of psychological therapy involving talking and behavior strategies rather than medication, it typically does not have physical side effects. However, discussing emotions can sometimes cause temporary discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am admitted to UIHC for urgent or planned heart bypass surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and agree to the study's requirements.

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I am having another procedure to improve blood flow.

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I have a severe illness other than heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion of Study Procedures

Intervention Delivery

Participant Adherence measure

+4 more

Secondary study objectives

Comprehensive Assessment of Acceptance Commitment Therapy Processes (CompACT)-15

Generalized Anxiety Disorder Questionnaire (GAD-7)

MacNew Heart Disease Health Related Quality of Life (HRQoL)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ACT Intervention groupExperimental Treatment1 Intervention

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.

Group II: Control treatment as usual (TAU) groupActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and commitment therapy

2019

N/A

~60

0 / 4Eligibility criteria met