Randomized controlled trial of mindfulness training as complementary therapy in adults with structural heart disease

Randomized controlled trial of mindfulness training as complementary therapy in adults with structural heart disease - Mindfulness training as complementary therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38306

Enrollment

330

Registered

2012-05-11

Start date

2012-06-18

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

structural heart disease

Interventions

Intervention: The intervention is a mindfulness training and consists of a structured standardized online program, which has been used extensively in the normal population (http://www.psychologiema

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults 18 to 65 years old known to have structural heart disease (congenital heart disease and cardiomyopathy)

Exclusion criteria

Exclusion criteria: planned operation or percutaneous intervention inability or unwillingness to give informed consent inability to understand Dutch, inability to read or write Dutch no internet acess or no email or no cell phone

Design outcomes

Primary

Measure	Time frame
Primary outcome: * exercise tolerance	—

Secondary

Measure	Time frame
Key secondary outcome: * quality-of-life (SF36), using the mental- and physical composite outcome scales Other secondary outcomes: * heart rate (a marker of cardiac fitness) * NTproBNP (a biomarker for heart failure) * composite endpoint (all-cause mortality, heart failure, arrythmia, cardiac surgery, percutaneous cardiac intervention, electrical cardioversion) * psychological well-being (anxiety and depression) * Social support (Blumenthal PSSS12) * preference values (societal EuroQol EQ-5D-5L values, and the patients values though the VAS rating scale) * health care costs * related non-health care costs (Tic-P)	—

Measure

Time frame

Key secondary outcome: * quality-of-life (SF36), using the mental- and physical composite outcome scales Other secondary outcomes: * heart rate (a marker of cardiac fitness) * NTproBNP (a biomarker for heart failure) * composite endpoint (all-cause mortality, heart failure, arrythmia, cardiac surgery, percutaneous cardiac intervention, electrical cardioversion) * psychological well-being (anxiety and depression) * Social support (Blumenthal PSSS12) * preference values (societal EuroQol EQ-5D-5L values, and the patients values though the VAS rating scale) * health care costs * related non-health care costs (Tic-P)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)