Objective of this study is to determine (1) whether mindfulness training has an additional clinical and psychological effect to standard care, and (2) whether offering mindfulness training is a cost-effective intervention, in adult patients with…
ID
Source
Brief title
Condition
- Myocardial disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:
* exercise tolerance
Secondary outcome
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)
Background summary
There is increasing evidence suggesting that mindfulness training (also know as
mindfulness-based stress reduction or mindfulness meditation) has a beneficial
effect in patients with cardiovascular disease. Objective of this study is to
determine whether mindfulness training has beneficial clinical and
psychological effects, and whether offering the training is effective and
cost-effective, in adult paitents with structural heart disease.
Evidence is accumulating that mindfulness training and related therapies can be
used as effective and safe adjuncts to medical treatment for a number of common
clinical conditions including depression, insomnia, anxiety, post-traumatic
stress, irritable bowel syndrome, nausea, pain, diabetes, hypertension and
cardiovascular disease.
Some studies suggest that mindfulness training may have a beneficial clinical
effect in patients with cardiovascular disease or those at increased
cardiovascular risk.
In addition, psychological problems and symproms of depression and anxiety
appear to be amenable to mindfulness meditation.
Study objective
Objective of this study is to determine
(1) whether mindfulness training has an additional clinical and psychological
effect to standard care, and
(2) whether offering mindfulness training is a cost-effective intervention, in
adult patients with structural heart disease (congenital heart disease and
cardiomyopathy)
Study design
Randomized controlled trial
Intervention
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.psychologiemagazine.nl/web/Trainingen/Online-training-mindfulness.ht
m). Every 3 days the patient receives an email message with a link to a website
where they are offered text explanations, video clips, sound tracks with
mindfulness exercises, assignments that need to be filled out, and practice
suggestions for the coming few days. The program is further supported by emails
and intermittent text messages on the patient*s cell phone. The duration of the
training will be 100 days. Various materials are offered for continuing
practice thereafter. The low cost of the online programme (¤ 30,-) gives the
program the potential of being a cost effective intervention. Adherence to the
intervention will be monitored by including additional questions and by
recording login time.
In addition, all patients will receive usual care.
Study burden and risks
Nature and extent of the burden and risks associated with participation:
Patients in the
active intervention arm will be offered online mindfulness training for the
duration of 100 days.
At 5 points in time over the course of 2 years all patients will undergo
exercise tolerance
testing, ECG, and NTproBNP measurement and they will be asked to fill out
questionnaires
concerning quality-of-life, preference values, psychological well-being,
medical resource use,
and non-health care costs
's-Gravendijkwal 230
3065 CE Rotterdam
NL
's-Gravendijkwal 230
3065 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Adults 18 to 65 years old known to have structural heart disease (congenital heart disease and cardiomyopathy)
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
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 | NL36710.078.11 |