Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
Condition: Coronary Artery Disease; Ischemic Heart Disease; Coronary Heart Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases
Study type: Interventional

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.
    

Intervention name(s): CLIMB intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral Medicine; Clinical Trial; Cardiology; Health Behavior; Healthy Lifestyle; Self Efficacy