In the Happy Hart study we investigate whether adding this mindfulness program to the standard treatment of people with cardiovascular diseases leads to a better quality of life, better mental health and a healthier lifestyle compared to the…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life measured with SF-12 questionnaire over the twelf month study
period.
Secondary outcome
- 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)
Background summary
A cardiovascular disease can hinder patients in their daily life. About 1 in 5
people with cardiovascular disease suffer from stress and feelings of sadness
and anxiety. This has a major impact on quality of life and can worsen the
outcomes of regular treatment. Furthermore, many cardiovascular patients are
urged to adopt a healthier lifestyle, since cardiovascular diseases are often
the result of an unhealthy lifestyle. Mindfulness seems to be a promising way
to get started with stress reduction and lifestyle change.
Mindfulness programs such as the 8-week mindfulness-based stress reduction
program (MBSR) have been used successfully for years in people with stress,
pain, psychological complaints (such as depression) and various chronic
diseases. In this study, mindfulness training is also aimed at developing and
maintaining a healthy lifestyle.
Study objective
In the Happy Hart study we investigate whether adding this mindfulness program
to the standard treatment of people with cardiovascular diseases leads to a
better quality of life, better mental health and a healthier lifestyle compared
to the standard treatment alone. If this program proves to be beneficial, the
study may help make it available as standard of care for this patient
population.
Study design
2-group, single-blind, randomized, pragmatic study consisting of an
intervention interval of 8 weeks and a follow-up period of 10 months.
Patients are randomly assigned to the 8-week mindfulness program as an adjunct
to usual treatment (intervention group n = 120) or to usual care (control group
n = 120). Patients in the intervention group can attend the mindfulness
training live online or in person, depending on their preference and the corona
measures in place.
Intervention
8-week mindfulness program
Study burden and risks
Participation in this study is not associated with any risks or side effects.
It does take time to participate in the 8-week (online/live) meetings (8x2.5
hours), to practice at home (30 min per day for 8 weeks), and to complete the
questionnaires (3x30 min).
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66291.100.18 |