1. To evaluate the feasibility of a mindfulness-based intervention in patients with chronic heart failure.2. To have a preliminary test of the effectiveness of the mindfulness-based intervention in patients with chronic heart failure regarding…
ID
Source
Brief title
Condition
- Heart failures
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcomes will be measured before and after the intervention by means of
validated questionnaires. These measure the extent of psychological distress
(including symptoms of anxiety and depression), positive and negative affect,
fatigue, and quality of life. In addition, an evaluation form will be used to
determine the practical feasibility of the study in this group.
Secondary outcome
Not applicable.
Background summary
Patients with chronic heart failure often report psychological distress
(including symptoms of anxiety and depression) and a poor quality of life. In
addition, these symptoms are associated with a poor prognosis in these patients.
An effective method to reduce these complaints would be welcome. A new method
to reduce distress and to enhance quality of life is based on training in open,
nonjudgmental and mindful attention to whatever happens in each successive
moment (mindfulness). In various patient groups, positive results have been
obtained: reduced symptoms of distress and elevated quality of life. However,
in patients with chronic heart failure this intervention has not been applied
yet.
Study objective
1. To evaluate the feasibility of a mindfulness-based intervention in patients
with chronic heart failure.
2. To have a preliminary test of the effectiveness of the mindfulness-based
intervention in patients with chronic heart failure regarding stress reduction
and enhancement of quality of life.
Study design
A pilot intevention study in patients with chronic heart failure, who report
substantial complaints of distress. They will be divided into two groups: an
intervention and a control group that will be matched regarding important
characteristics. Measurements will be done along a pre-post-test design.
Intervention
The intervention consists of weekly group sessions of two hours and thirty
minutes during which participants will practice in mindfulness: mindful
breathing, mindful slow movement, mindful sitting, etc. In addition, a half-day
of practice is included in the sixth week and participants are requested to
practice at home as well.
Study burden and risks
The intervention is a mild psychological training aiming at stress reduction
and enhancement of quality of life and therefore does not hold any risk for the
patients. The participants are expected to invest a substantial amount of time
(24 hours of meetings plus homework). It is expected that this investment will
pay off in stress reduction and enhancement of well-being.
Postbus 90153
5000 LE Tilburg
Nederland
Postbus 90153
5000 LE Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
- Systolic heart failure
- LVEF < 40%
- stable regarding medication during last month
- functional NYHA-class I-III
- sufficient understanding of Dutch
- self-reported psychological stress
Exclusion criteria
- age > 80 years
- hospitalisation or medical invasive interventions within a month before inclusion
- cognitive impairment
- treatment for a psychological disorder
Design
Recruitment
Medical products/devices used
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 | NL11971.008.06 |