No registrations found.
ID
Source
Brief title
Health condition
medically unexplained symptoms, somatoform disorders, undifferentiated somatoform disorder, functional syndrome, somatisation, randomized controlled trial, mindfulness training, frequent attenders.
onverklaarde lichamelijke klachten, ongedifferentieerde somatoforme stoornis, somatoforme stoornissen, somatisatie, gerandomiseerd gecontroleerd onderzoek, mindfulnesstraining, frequente huisartsbezoeker
Sponsors and support
Intervention
Outcome measures
Primary outcome
Perceived physical health, measured by the visual analogue scale of the EQ-5D and the SF-36 (physical component summary).
Secondary outcome
1. Psychological and physical symptoms (patient health questionnaire, PHQ);
2. Quality of life (SF-36 and EQ-5D);
3. Health anxiety (Whitely Index);
4. Mindfulness skills (Five facet mindfulness questionnaire, FFMQ);
5. Rumination (Rumminative response style, RRS);
6. Medical consumption (Cost Diary for medical consumption);
7. Work limitations (work limitation questionnaire, WLQ);
8. Relationship with GP (difficult doctor patient relationship-9, DDPRQ-9);
9. Sense of coherence (SoC-13).
Background summary
The Mindful Body Trial is a randomized controlled trial in which the effects of mindfulness training on patients with medically unexplained symptoms are measured. We are interested in the effects on the perceived physical health and the cost-effectiveness of mindfulness compared to patients who receive usual care. Patients are recruited in general practices in the Netherlands.
Study objective
Mindfulness training is effective for patients with medically unexplained symptoms. The perceived physical health improves. The training is cost effective in terms of improved quality of life versus the medical costs.
Study design
All primary and secondary measures are measured at baseline, 3 months after baseline and 12 months after baseline. The medical consumption and the participation in work are measured every month.
The relation with the GP is measured at baseline and after one year.
Intervention
Intervention:
Mindfulness training (mindfulness based cognitive therapy), consists of 8 weekly sessions of 2,5 hours duration in which patients take part in meditation, yoga and cognitive therapy exercises. Homework takes about 45 minutes per day. Patients share their experience with the group members and the trainer.
Control:
Care as usual during follow up, no participation in mindfulness training. After follow up ( 1 year) patients in the control condition are offered mindfulness training.
Hiske Ravesteijn, van
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3615313
h.vanravesteijn@psy.umcn.nl
Hiske Ravesteijn, van
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3615313
h.vanravesteijn@psy.umcn.nl
Inclusion criteria
1. Patients with medically unexplaind symptoms for at least 6 months;
2. Patients who frequently visit the general practitioner, belonging to top 10% of frequent attenders.
Exclusion criteria
1. Patients younger than 18 and older than 70 years;
2. Patients with insufficient understanding of the Dutch language;
3. Patient with a physical disease that fully accounts for the physical symptoms;
4. Patient with unexplained physical symptoms, but without effects on the quality of life;
5. Patients with psychosis or bipolar disorder in the medical history;
6. Patients with mental retardation;
7. Patients with severe psychical disease;
8. Patients who have already had mindfulness training.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2105 |
| NTR-old | NTR2222 |
| CCMO | NL27551.091.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON33324 |