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Interns InSight Study: The effect of mindfulnesstraining on the wellbeing and functioning of medical interns.

- candidate number9088
- NTR NumberNTR2745
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2011
- Secondary IDs2010/388 CMO Arnhem-Nijmegen
- Public TitleInterns InSight Study: The effect of mindfulnesstraining on the wellbeing and functioning of medical interns.
- Scientific TitlePsychopathology, mental health and professionalism in medical interns during their internships and the effect of a mindfulness based stress reduction training hereon.
- hypothesisBased on current literature we hypothesize that mindfulness based stress reduction training reduces psychological distress and improves 'positive mental health' in medical interns. Possibly MBSR can prevent psychological distress in the future.
- Healt Condition(s) or Problem(s) studiedPsychological distress, Positive mental health, Medical students
- Inclusion criteriaMedical interns (male and female) of 18 years and older starting their clinical practice in the Radboud University Nijmegen.
- Exclusion criteria1. Students younger than 18 years old;
2. Students with insufficient understanding of the Dutch language;
3. Students who have prior experience with a mindfulness based stress reduction training;
4. Students who do not agree in being contacted by the coordinating researcher if there is concern about the amount of psychological distress of the student.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-feb-2011
- planned closingdate1-jan-2014
- Target number of participants150
- InterventionsIntervention:
Mindfulness training (mindfulness based stress reduction), consists of 8 weekly sessions of 2,5 hours in which students take part in meditation, yoga and cognitive therapy exercises. Homework takes about 30 minutes per day. Students share their experience with the group members and the trainer. The training is adapted to discuss topics which are relevant in medical training.

The control group follows the curriculum as usual (normal internships).
- Primary outcomeThe primary outcome measure is the score of the interns on the Brief Symptom Inventory which measures the amount of psychological distress experienced by the students. This validated questionnaire is a shortened version of the Symptom Checklist (SCL-90). It exists of 53 items divided over 9 symptom dimensions like depression, anxiety and somatization. From the total score a General Severity Index is calculated, which is a commonly used and validated outcome measure in studies.
- Secondary outcome1. Burnout, measured by the Utrechtse Burnout Schaal (UBOS-C), the Dutch translation of the widely used Maslach Burnout Inventory;
2. Suicidality measured by the questions of the suicidality dimension of the MINI;
3. Irrational beliefs measured by the Irrational Beliefs Inventory;
4. Mindfulness measured by the Five Facet Mindfulness Questionnaire (FFMQ);
5. Mental health measured by the Positive mental health continuum - short form;
6. Life satisfaction measured by the life satisfaction questionnaire;
7. Empathy measured by the Jefferson Scale of physician empathy;
8. Professionalism will also be assessed by examining study results and outcome of clinical performance in simulation patients during the central clinical education.
- TimepointsQuestionnaires will be filled in at baseline and after 8 weeks (after intervention). Follow-up measures will be at 7, 12, 15 and 20 months.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center St. Radboud
- PublicationsN/A
- Brief summaryThe Interns InSight Study is a randomized controlled trial in which the effects of mindfulness training on psychological distress, wellbeing and professionalism of medical interns during their internships are measured. Medical students starting their internships in the Radboud University Nijmegen are asked to participate.
- Main changes (audit trail)
- RECORD9-feb-2011 - 15-jun-2015

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