Clinical trial NCT03629158: Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
Official title: Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Coronary Heart Disease
Keywords: Behavioral Medicine
Clinical Trial
Cardiology
Health Behavior
Healthy Lifestyle
Self Efficacy
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 33
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-efficacy for managing coronary artery disease
timeFrame: 2-weeks/post-treatment
measure: Self-efficacy for managing coronary artery disease
timeFrame: 30-day follow-up
measure: Illness perceptions
timeFrame: 2-weeks/post-treatment
measure: Illness perceptions
timeFrame: 30-day follow-up
measure: Participant-reported depressive symptoms
timeFrame: 2-weeks/post-treatment
measure: Participant-reported depressive symptoms
timeFrame: 30-day follow-up
measure: Participant-reported anxiety symptoms
timeFrame: 2-weeks/post-treatment
measure: Participant-reported anxiety symptoms
timeFrame: 30-day follow-up
Secondary outcomes:
measure: Participant-reported symptoms of demoralization
timeFrame: 2-weeks/post-treatment, 30-day follow-up
measure: Dietary patterns as measured using the brief dietary assessment and intervention tool: the Starting the Conversation (STC) questionnaire.
timeFrame: 2-weeks/post-treatment, 30-day follow-up
measure: Physical activity patterns
timeFrame: 2-weeks/post-treatment, 30-day follow-up
measure: Number of cigarettes smoked per week over the past two weeks
timeFrame: 2-weeks/post-treatment, 30-day follow-up
measure: Confidence in resisting over-eating and unhealthy foods (i.e., Diet self-efficacy)
timeFrame: 2-weeks/post-treatment, 30-day follow-up
measure: Confidence in exercising consistently (i.e., Exercise self-efficacy)
timeFrame: 2-weeks/post-treatment, 30-day follow-up
Other outcomes:
measure: Satisfaction with CLIMB intervention
timeFrame: 2-weeks/post-treatment (only for those who received the intervention)
measure: Program development questionnaire
timeFrame: 2-weeks/post-treatment (only for those who received the intervention)
measure: CLIMB Intervention Acceptability: Would participants recommend this intervention to other patients with coronary artery disease?
timeFrame: 2-weeks/post-treatment (only for those who received the intervention)
measure: Percentage of referred and eligible patients agreeing to participate (Feasibility Assessment)
timeFrame: Through study completion: anticipated 1 year
measure: Percentage of participants completing CLIMB intervention through 30-day follow-up (Feasibility Assessment)
timeFrame: Through study completion: anticipated 1 year
Locations:
city: Orlando
country: United States
facility: UCF Health
state: Florida
Study officials:
affiliation: University of Central Florida
name: Chelsea H. Wiener, MS
role: PRINCIPAL_INVESTIGATOR
References: