Skip to content

Effectiveness of mindfulness-based stress reduction for improving quality of life in patients with cardiovascular disease: a randomised controlled trial

Effectiveness of mindfulness-based stress reduction for improving quality of life in patients with cardiovascular disease: a randomised controlled trial - Mind Our Heart Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55428
Enrollment
240
Registered
2018-11-26
Start date
2021-10-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

atherosclerotic vascular disease Cardiovascular disease

Interventions

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a. Adult (18 years and older); b. Established atherosclerotic cardiovascular disease (i.e. coronary artery disease, ischemic heart failure, peripheral artery disease).

Exclusion criteria

Exclusion criteria: a. Current acute cardiovascular event (myocardial infarction, major stroke, acute limb ischemia in prior 2 weeks) b. Critical limb ischemia c. Terminal illness d. History of psychosis e. Current severe psychiatric disorder f. Current psychotherapy g. Non-Dutch speaking h. Cognitive impairment i. Behavioural problems that distort group meetings j. Active mindfulness/meditation or yoga practice within the past year k. Current participation in another clinical trial that possibly interferes with the study intervention or primary outcome

Design outcomes

Primary

MeasureTime frame
Quality of life measured with SF-12 questionnaire over the twelf month study period.

Secondary

MeasureTime frame
- Stress (PSS-10) - Depression (PHQ-9) - Anxiety (GAD-7) - Wellbeing (WHO-5) - Self-efficacy (GSES) - Fysical activity (EVS) - Nutrition (MEDAS) - Smoking (ja/nee) - Alcohol use (AUDIT-C) - Sleep (SQS) - Fatigue (VVV) - Body Mass Index (lichaamsgewicht- en lengte) - Medication adherence (SMAQ) - Cost-effectiveness (EQ-5D-5L)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)