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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease, Ischemic Heart Disease, Coronary Heart Disease

Intervention / Treatment
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* Behavioral: CLIMB intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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%. 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: Age < 30 years or > 79 years Cognitive impairment as indicated by diagnosis in medical chart Psychotic symptoms as indicated by diagnosis in medical chart Any documented non-skin malignancy, malignant melanoma, or advanced kidney disease (indicated by stage 4 or 5 or on dialysis) Ejection fraction < 30% 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. Women who are pregnant or breast feeding Non-English-speaking Participation in another clinical trial concurrently or within 30 days before screening Psychological safety concerns, including plans to harm oneself within the past two months and/or suicide attempt within the past year

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLIMB intervention<br>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<br>* 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.<br>|
| No Intervention: Treatment as usual (TAU)<br>The TAU group will continue to receive their regular medical care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Medicine, Clinical Trial, Cardiology, Health Behavior, Healthy Lifestyle, Self Efficacy