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

NCT03629158 | Completed

• 1 other identifier: SBE-18-14085
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Ischemic Heart Disease; Coronary Heart Disease

Keywords

Behavioral Medicine; Clinical Trial; Cardiology; Health Behavior; Healthy Lifestyle; Self Efficacy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Participant-reported symptoms of demoralization

  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.

  2-weeks/post-treatment, 30-day follow-up

• Physical activity patterns

  2-weeks/post-treatment, 30-day follow-up

• Number of cigarettes smoked per week over the past two weeks

  2-weeks/post-treatment, 30-day follow-up

• Confidence in resisting over-eating and unhealthy foods (i.e., Diet self-efficacy)

  2-weeks/post-treatment, 30-day follow-up

Other Outcomes (5)

• Satisfaction with CLIMB intervention

  2-weeks/post-treatment (only for those who received the intervention)

• Program development questionnaire

  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?

  2-weeks/post-treatment (only for those who received the intervention)

Study Arms (2)

CLIMB intervention

EXPERIMENTAL

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

Treatment as usual (TAU)

NO INTERVENTION

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

Interventions

CLIMB intervention BEHAVIORAL

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.

CLIMB intervention

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

UCF Health

Orlando, Florida, 32817, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Health Behavior

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Officials

• Chelsea H. Wiener, MS

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 14, 2018
• Study Start: September 11, 2018
• Primary Completion: June 27, 2019
• Study Completion: July 9, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)