|- candidate number||7777|
|- NTR Number||NTR2222|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-feb-2010|
|- Secondary IDs||NL27551.091.09 / 40-00703-98-8512 ; ABR nr. / ZonMW |
|- Public Title||Mindful Body Trial: Mindfulness training for medically unexplained symptoms.
|- Scientific Title||Effectiveness and cost-effectiveness of mindfulness training for patients with medically unexplained symptoms.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Somatoform disorder, Unexplained Physical Symptoms, Frequent attenders, Mindfulness training|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||9-dec-2009|
|- planned closingdate||1-dec-2011|
|- Target number of participants||100|
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.
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.
|- 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).
|- Timepoints||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.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Hiske Ravesteijn, van|
|- CONTACT for SCIENTIFIC QUERIES|| Peter Lucassen|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||19-feb-2010 - 5-mrt-2010|