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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629158
• Other study ID #: SBE-18-14085
• Status: Completed
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: July 9, 2019

Study information

• Verified date: July 2019
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 9, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	UCF Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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