Cardiovascular disease (I05 to I71, as well as I95 or I97, ICD-10) and mild or moderate mental illness or stress or exhaustion I05-I09 I10-I15 I20-I25 I26-I28 I30-I52 I60-I69 I70 I71 I95 I97
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: We include patients aged 18 to 65 years patients who receive a rehabilitation at our study center due to a cardiovascular disease (ICD-10 I05 to I71 as well as I95 and I97) assigned by the Federal German Pension Insurance or the German Pension Insurance North, and for whom mild or moderate mental illness or stress or exhaustion are recorded in the application documents for medical rehabilitation. For patients assigned by the Federal German Pension Insurance, mental illness or stress or exhaustion is determined by the socio-medical service of the Federal German Pension Insurance. For patients assigned by the German Pension Insurance North, this is determined by a cardiologist of the study center. The determination of mild or moderate mental illness or stress or exhaustion will be done in advance of the program using the documents for claiming the rehabilitation, only.
Exclusion criteria
Exclusion criteria: Patients with severe mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, mania, severe unipolar depression), severe heart failure (at least NYHA stage III), and significant limitations with the German language are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac anxiety; How? Continuously, 0 to 4 points, total score of the German 17-item version of the Cardiac Anxiety Questionnaire (Hoyer et al., 2008); When? Start and end of the rehabilitation, 3-month follow-up, 12-month follow-up. Our primary outcome is cardiac anxiety twelve months after the end of rehabilitation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fear; How? Continuously, 0 to 4 points, subscale of the German 17-item version of the Cardiac Anxiety Questionnaire (Hoyer et al., 2008); When? Start and end of the rehabilitation, 3-month follow-up, 12-month follow-up Avoidance; How? Continuously, 0 to 4 points, subscale of the German 17-item version of the Cardiac Anxiety Questionnaire (Hoyer et al., 2008); When? Start and end of the rehabilitation, 3-month follow-up, 12-month follow-up Attention; How? Continuously, 0 to 4 points, subscale of the German 17-item version of the Cardiac Anxiety Questionnaire (Hoyer et al., 2008); When? Start and end of the rehabilitation, 3-month follow-up, 12-month follow-up Change score of cardiac anxiety; How? Continuously, -4 to 4 points, total score of the German 17-item version of the Cardiac Anxiety Questionnaire (Hoyer et al., 2008); When? End of the rehabilitation, 3-month follow-up, 12-month follow-up Decrease in cardiac anxiety by 0.2 points; How? Yes/no, total score of the German 17-item version of the Cardiac Anxiety Questionnaire (Hoyer et al., 2008); When? End of the rehabilitation, 3-month follow-up, 12-month follow-up Depression; How? Continuously, 0 to 27 points, PHQ-D (Kroenke et al., 2010); When? Start and end of the rehabilitation, 3-month follow-up, 12-month follow-up Generalized anxiety; How? Continuously, 0 to 21 points, PHQ-D (Kroenke et al., 2010); When? Start and end of the rehabilitation, 3-month follow-up, 12-month follow-up Somatization; How? Continuously, 0 to 30 points, PHQ-D (Kroenke et al., 2010); When? Start and end of the rehabilitation, 3-month follow-up, 12-month follow-up Functional capacity; How? Continuously, 0 to 10 points, IRES-24 (Wirtz et al., 2005); When? Start and end of the rehabilitation, 3-month follow-up, 12-month follow-up Blood pressure; How? Continuously, systolic/diastolic in mmHg; When? Start and end of the rehabilitation Endurance; How? Continuously, ergometer performance in watts/kg; When? Start and end of rehabi | — |
Countries
Germany
Contacts
Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie