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Cognitive-behavioral rehabilitation in patients with cardiovascular diseases: a randomized controlled trial

Cognitive-behavioral rehabilitation in patients with cardiovascular diseases: a randomized controlled trial - CBR-CARDIO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029295
Enrollment
410
Registered
2022-06-21
Start date
2022-06-28
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Group 1: Four-week cognitive-behavioral cardiac rehabilitation program
The program complements conventional cardiac rehabilitation with additional psychological interventions and exercise therapy and follows the framework of cognitive-behavioral rehabilitation which was
https://doi.org/10.1055/a-1749-6379). Group 2: Four-week cardiac rehabilitation program in accordance with the guideline for the rehabilitation of cardiovascular disease (Deutsche Rentenversicherung,

Sponsors

Universität zu Lübeck Institut für Sozialmedizin und Epidemiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime 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

MeasureTime 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

Public ContactMatthias Bethge

Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie

matthias.bethge@uksh.de+49 451 50051280

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026