This study protocol describes a randomized controlled trial designed to evaluate whether cognitive-behavioral rehabilitation decreases cardiac anxiety compared to standard cardiac rehabilitation.
RCT (n=410)
Open-label
1:1 ratio, blocks of different size
No
Does a cognitive-behavioral rehabilitation program reduce cardiac anxiety compared to standard cardiac rehabilitation in patients with cardiovascular disease and mild or moderate mental illness or stress?
This study protocol outlines a randomized controlled trial to evaluate whether adding cognitive-behavioral interventions to standard cardiac rehabilitation reduces cardiac anxiety in patients with cardiovascular disease and mild-to-moderate mental distress.
Abstract Background Depression, generalized and cardiac anxiety, and posttraumatic stress disorder negatively affect disease severity, participation, and mortality in patients with cardiovascular disease. Psychological treatments within cardiac rehabilitation may improve the outcomes of these patients. We therefore developed a cognitive-behavioral rehabilitation program for patients with cardiovascular disease and mild or moderate mental illness or stress or exhaustion. In Germany, similar programs are well established in musculoskeletal rehabilitation and cancer rehabilitation. However, no randomized controlled trials have evaluated if such programs achieve better outcomes in patients with cardiovascular disease compared with standard cardiac rehabilitation. Methods Our randomized controlled trial compares cognitive-behavioral cardiac rehabilitation with standard cardiac rehabilitation. The cognitive-behavioral program complements standard cardiac rehabilitation with additional psychological and exercise interventions. Both rehabilitation programs last for four weeks. We enroll 410 patients with cardiovascular disease and mild or moderate mental illness or stress or exhaustion aged 18 to 65 years. Half of the individuals are randomly assigned to cognitive-behavioral rehabilitation and the other half to standard cardiac rehabilitation. Our primary outcome is cardiac anxiety 12 months after the end of rehabilitation. Cardiac anxiety is assessed with the German 17-item version of the Cardiac Anxiety Questionnaire. Secondary outcomes cover outcomes assessed by clinical examinations and medical assessments and a range of patient-reported outcome measures. Discussion This randomized controlled trial is designed to determine the effectiveness of cognitive-behavioral rehabilitation at decreasing cardiac anxiety in patients with cardiovascular disease and mild or moderate mental illness or stress or exhaustion. Trial registration German Clinical Trials Register (DRKS00029295, June 21, 2022).
Bethge et al. (Mon,) conducted a rct in Cardiovascular disease with mild or moderate mental illness or stress or exhaustion (n=410). Cognitive-behavioral rehabilitation vs. Standard cardiac rehabilitation was evaluated on Cardiac anxiety 12 months after the end of rehabilitation. This study protocol describes a randomized controlled trial designed to evaluate whether cognitive-behavioral rehabilitation decreases cardiac anxiety compared to standard cardiac rehabilitation.