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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Heart Disease; Ischemic Heart Disease
• Intervention / Treatment: Behavioral: CLIMB intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32817
      • UCF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLIMB intervention; 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.	Behavioral: CLIMB intervention; 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. Sessions range from 1-2 hours in length, including questionnaire completion. Participants will be given information and taught relevant skills to increase engagement in lifestyle behaviors relevant to cardiac health.
No Intervention: Treatment as usual (TAU); The TAU group will continue to receive their regular medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy for managing coronary artery disease	Participants will complete the Self-Efficacy for Managing Chronic Disease Scale-6 (SEMCD-6) to assess self-efficacy in managing coronary artery disease. Scale scores range from 1 (minimum) to 10 (maximum), with higher scores indicating greater self-efficacy in managing chronic disease (i.e., a better outcome).	2-weeks/post-treatment
Self-efficacy for managing coronary artery disease	Participants will complete the Self-Efficacy for Managing Chronic Disease Scale-6 (SEMCD-6) to assess self-efficacy in managing coronary artery disease. Scale scores range from 6 (minimum) to 60 (maximum), with higher scores indicating greater self-efficacy in managing chronic disease (i.e., a better outcome).	30-day follow-up
Illness perceptions	Participants will complete the Brief Illness Perception Questionnaire (B-IPQ) as a measure of how threatening they perceive their coronary artery disease to be. Scale scores range from 0 (minimum) to 80 (maximum), with higher scores indicating more threatening illness perceptions (i.e., a worse outcome).	2-weeks/post-treatment
Illness perceptions	Participants will complete the Brief Illness Perception Questionnaire (B-IPQ) as a measure of how threatening they perceive their coronary artery disease to be. Scale scores range from 0 (minimum) to 80 (maximum), with higher scores indicating more threatening illness perceptions (i.e., a worse outcome).	30-day follow-up
Participant-reported depressive symptoms	The Patient Health Questionnaire-9 (PHQ-9) will be administered to assess depressive symptoms. Scale scores range from 0 (minimum) to 27 (maximum) with higher scores indicating elevated depressive symptoms (i.e., a worse outcome).	2-weeks/post-treatment
Participant-reported depressive symptoms	The Patient Health Questionnaire-9 (PHQ-9) will be administered to assess depressive symptoms. Scale scores range from 0 (minimum) to 27 (maximum) with higher scores indicating elevated depressive symptoms (i.e., a worse outcome).	30-day follow-up
Participant-reported anxiety symptoms	The Generalized Anxiety Disorder-7 (GAD-7) will be administered to assess anxious symptoms. Scale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating elevated levels of anxiety symptoms (i.e., a worse outcome).	2-weeks/post-treatment
Participant-reported anxiety symptoms	The Generalized Anxiety Disorder-7 (GAD-7) will be administered to assess anxious symptoms. Scale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating elevated levels of anxiety symptoms (i.e., a worse outcome).	30-day follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-reported symptoms of demoralization	Symptoms of demoralization will be measured using the Demoralization Scale-II (DS-II). Scale scores range from 0 (minimum) to 32 (maximum), with higher scores indicating more demoralization (i.e., a worse outcome).	2-weeks/post-treatment, 30-day follow-up
Dietary patterns as measured using the brief dietary assessment and intervention tool: the Starting the Conversation (STC) questionnaire.	Participants will report dietary patterns using the Starting the Conversation (STC) questionnaire. Scale scores range from 0 (minimum) to 16 (maximum) with lower scores indicating healthier dietary patterns (i.e., a better outcome).	2-weeks/post-treatment, 30-day follow-up
Physical activity patterns	The Global Physical Activity Questionnaire (GPAQ) will be administered to participants as a measure of physical activity behavior.	2-weeks/post-treatment, 30-day follow-up
Number of cigarettes smoked per week over the past two weeks	Participants who smoked a cigarette in the past month will complete a smoking questionnaire that assesses the number of cigarettes smoked per week over the past two weeks, motivation and readiness to quit smoking, in addition to interest in receiving smoking cessation referrals.	2-weeks/post-treatment, 30-day follow-up
Confidence in resisting over-eating and unhealthy foods (i.e., Diet self-efficacy)	Participant diet self-efficacy will be assessed with the scenario-based measure The Diet Self Efficacy Scale (DIET-SE). Scale scores range from 0 (minimum) to 44 (maximum), with higher scores indicating greater self-efficacy/confidence in dieting situations (i.e., a better outcome).	2-weeks/post-treatment, 30-day follow-up
Confidence in exercising consistently (i.e., Exercise self-efficacy)	Participant self-efficacy for exercise will be measured using the Exercise Confidence Survey (ECS). Scores range from 12 (minimum) to 60 (maximum), with higher scores indicating greater self-efficacy for exercise (i.e., a better outcome).	2-weeks/post-treatment, 30-day follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with CLIMB intervention	Participants will complete a satisfaction survey regarding their participation in the CLIMB intervention.	2-weeks/post-treatment (only for those who received the intervention)
Program development questionnaire	Participants will complete a program development questionnaire regarding their participation in the CLIMB intervention to inform further development of the intervention.	2-weeks/post-treatment (only for those who received the intervention)
CLIMB Intervention Acceptability: Would participants recommend this intervention to other patients with coronary artery disease?	Acceptability of the intervention will be assessed with the Yes/No question: "Would you recommend this intervention to other patients with coronary artery disease?" At least 80% need to respond "Yes" for the treatment to be considered acceptable.	2-weeks/post-treatment (only for those who received the intervention)
Percentage of referred and eligible patients agreeing to participate (Feasibility Assessment)	The program will only be considered feasible if at least 60% of referred and eligible patients agree to participate.	Through study completion: anticipated 1 year
Percentage of participants completing CLIMB intervention through 30-day follow-up (Feasibility Assessment)	The study will only be considered feasible if at least 75% of the consented IG participants complete the study intervention and outcome measurements through the 30-day follow-up.	Through study completion: anticipated 1 year

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Chelsea H. Wiener, MS, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Actual): June 27, 2019
• Study Completion (Actual): July 9, 2019

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Clinical Trial; Self Efficacy; Health Behavior; Cardiology; Healthy Lifestyle; Behavioral Medicine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: SBE-18-14085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No