The objective of this research is to examine the (cost-)effectiveness of mindfulness training in patients with persistent medically unexplained symptoms in primary care.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
onverklaarde lichamelijke klachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcome measure is the perceived physical health status in the past
week. This is measured by the EQ-5D, a validated questionnaire for measurement
of the quality of physical health and quality of life.
Secondary outcome
Secondary outcome measures are: psychological symptoms (Patient Health
Questionnaire, PHQ-15 ad PHQ-9), quality of life (SF-36), physical health as
measured by the SF-36 Physical Component Summary (PCS), health anxiety (Illness
Attitude Scale), mindfulness skills (Five Facet Mindfulness Questionnaire,
FFMQ), rumminative response style (RRS), medical consumption (Cost Diary for
medical consumption) and coping (Orientation to life questionnaire).
Background summary
Medically unexplainded complaints are very common. Especially the patients with
persistent medically unexplained symptoms have high levels of functional
impairment and a relatively low quality of life. For the general practitioner
these patients take a lot of time and energy. Cognitive behavioral therapy is
one of the most effective therapies within the field of medically unexplained
symptoms. Mindfulness based approaches are a new development within the field
of cognitive behavioral therapy. Mindfulness training is a group
skills-training in which patients learn to become more aware of their thoughts,
feelings and bodily sensations and to relate to them in a nonjudgmental way.
Mindfulness training has been developed as a stress reduction training.
Research has shown that after two months of training the participants are able
to relax more easily, demonstrate a decrease of psychological and physical
symptoms and can better cope with chronic pain. Therefore, we expect
mindfulness training to be effective in patients with medically unexplained
symptoms.
Study objective
The objective of this research is to examine the (cost-)effectiveness of
mindfulness training in patients with persistent medically unexplained symptoms
in primary care.
Study design
A randomized controlled clinical trial with patients with medically unexplainde
symotoms in primary care. Patients who accept to take part in the study will be
randomized to intervention (mindfulness training) or control condition (usual
care). Patients will be followed up for one year. Patients in the control group
condition will be offered mindfulness training one year after the start of the
trial. This research is a collaboration between the department of general
practice and the department of psychiatry at the UMCN St Radboud Nijmegen.
Intervention
The intervention, mindfulness training, consists of 8 weekly sessions of 2,5
hours duration in which patients take part in meditation, yoga and cognitive
therapy exercises. The aim is to pay attention to the present moment and accept
bodily sensations, emotions and thoughts rather than to try to get rid of them.
Participants share their experiences with the group members and the trainer.
Study burden and risks
Patients randomised to the mindfulness training will be invited in the 8-week
course and will be expected to practive at home on a daily basis.
PO box 9101
6500HB Nijmegen
NL
PO box 9101
6500HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients with medically unexplaind symptoms for at least 6 months
Patients who frequently visit the general practitioner, belonging to top 10% of frequent attenders
Patienst have visited the general practitioner at least once in the past 3 months
Exclusion criteria
Patients younger than 18 and older than 70 years
Patients with insufficient understanding of the Dutch language
Patients with severe psychiatric problems (major depression, psychosis)
Patients with mental retardation
Patients with severe psychical disease
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL27551.091.09 |
| OMON | NL-OMON26867 |