Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease

University of Central Florida

Status: Completed

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Coronary Heart Disease

Treatments: Behavioral: CLIMB intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03629158

SBE-18-14085

Details and patient eligibility

About

The purpose of this study is to examine the effectiveness of a lifestyle intervention for patients living with stable coronary artery disease (CAD). One group will receive the the intervention, and the other will receive treatment as usual (TAU). The investigators hypothesize that, compared to the TAU group, participants receiving the intervention will 1) experience greater confidence in managing their cardiac disease, as indicated by perceived self-efficacy and illness perceptions; 2) experience greater psychological adjustment as indicated by depressive, anxious, and demoralization symptoms; 3) experience greater engagement in health behaviors including healthy eating and physical activity.

Full description

Participants will be randomly assigned to one of two research groups: the intervention group (IG) and the treatment as usual (TAU) group. The IG will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB"). CLIMB is a 3-session (2-week) intervention. One session includes health behavior feedback, and patient selection of relevant lifestyle modules based on values clarification. In the remaining two sessions, participants will complete two of five elective lifestyle modules: Healthy Eating, Physical Activity, Reducing Stress and Worry, Mood Management, and Smoking Cessation Education. Intervention components include information provision, goal setting, problem solving, and elements of cognitive behavioral therapy.

Participants in the IG will complete a Baseline assessment, three intervention sessions, a 30-day follow-up, and a 3-month follow-up. Baseline and Session 1 will take place on the same day. Sessions 1, 2, and 3 will be spaced approximately one week apart from one another (1 week in-between Sessions 1 and 2, and 1 week in-between Sessions 2 and 3). The 30-day follow-up will occur approximately 30-days after Session 3. The 3-month follow-up will occur approximately 3 months after Session 3. Assessment measures will be filled out at Baseline, at Post-treatment (end of Session 3), at 30-day follow-up, and at 3-month follow-up. The TAU group will fill out assessment measures at comparable time points, with the exception that there will be no 3-month follow-up. After completing their 30-day follow-up measures, TAU members may elect to receive the CLIMB intervention.

Enrollment: 33 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. CAD as indicated by history of at least one myocardial infarction, at least one coronary artery bypass graft surgery, at least one coronary stent, and/or at least one coronary vessel with stenosis greater than or equal to 70%.
2. Stable status as indicated by no myocardial infarctions, unstable angina, or other acute coronary syndromes within the past 3 months, no coronary revascularizations within the past 3 months, and no planned revascularizations.

Exclusion criteria

1. Age < 30 years or > 79 years
2. Cognitive impairment as indicated by diagnosis in medical chart
3. Psychotic symptoms as indicated by diagnosis in medical chart
4. Any documented non-skin malignancy, malignant melanoma, or advanced kidney disease (indicated by stage 4 or 5 or on dialysis)
5. Ejection fraction < 30%
6. Physician determination of inappropriateness for study, due to anticipated life expectancy of <1 year, presence of a survival limiting or uncontrolled illness, and/or hemodynamically important valvular disease.
7. Women who are pregnant or breast feeding
8. Non-English-speaking
9. Participation in another clinical trial concurrently or within 30 days before screening
10. Psychological safety concerns, including plans to harm oneself within the past two months and/or suicide attempt within the past year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

CLIMB intervention

Experimental group

Description:

The intervention group will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB") intervention. Participants will participate in a 3-session, one-on-one intervention that takes place over the course of two weeks.

Treatment:

Behavioral: CLIMB intervention

Treatment as usual (TAU)

No Intervention group

Description:

The TAU group will continue to receive their regular medical care.