I20-I25 F32 F41 F43 F54
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Currently or recently (12 or score on Perceived Stress Scale [PSS-4] >5) at =2.5 months after iinitial prescreening 3. Insufficient cardiac risk factor control (based on ESC guideline criteria) at =2.5 months after initial prescreening
Exclusion criteria
Exclusion criteria: 1. Acute coronary syndrome or cardiac surgery between prescreening and enrolment 2. Comorbidities with estimated survival <1 year 3. severe mental illness (e.g., acute psychoses, addiction other than tobacco) 4. severe cognitive impairment like dementia or impaired ability to communicate 5. participation in another treatment trial likely to affect the relevant endpoints or interfering with the trial procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment defined as =50% increase in HRQoL (HeartQoL score) from baseline to month 12 (i.e. (score12 months-score baseline)/(42-score baseline)=50%, where 42 is the maximum score). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to month 12 in: (1) continuous HeartQoL score (2) Composite medical risk factor score (systolic blood pressure + LDL cholesterol + HbA1c + smoking status + physical activity); (3) psychosocial status (distress etc.); (4) single elements of composite endpoint; medication adherence, physical exercise, dietary pattern, smoking status, angina symptoms; (5) treatment satisfaction; (6) number of adverse cardiovascular events; (7) HRQoL and variables listed under (1)-(5) until end of follow-up | — |
Countries
Germany
Contacts
Universitätsmedizin Göttingen, Klinik für Psychosomatische Medizin und Psychotherapie