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Acupuncture in the treatment of Schizophrenia, Depression and Sleep.


- candidate number10496
- NTR NumberNTR3132
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-nov-2011
- Secondary IDs2008331 Ethikkommission der Aerztekammer Nordrhein
- Public TitleAcupuncture in the treatment of Schizophrenia, Depression and Sleep.
- Scientific TitleAcupuncture in the treatment of Schizophrenia, Depression and Sleep.
- ACRONYM
- hypothesisEffects of acupuncture (add on) treatment are investigated.
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Depression, Sleep disorders
- Inclusion criteriaICD-10 diagnosis of schizophrenia for one group, or depression for the other group.
The diagnosis is made by the treating psychiatrist, who, upon concluding that the patient would be suitable for the project, then informs the patient about it.
- Exclusion criteriaAddiction, other neurological conditions.
The psychiatrists that inform the patients about the study, also have access to any other diagnosis that the patients might have. Upon entering the study, the exclusion criteria are checked once again in the electronic patient information system of the clinic.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate31-dec-2012
- Target number of participants200
- InterventionsDuring 12 weeks the patients will receive acupuncture, once a week during one hour. The treatment will take place in a room with comfortable chairs. Two acupuncturists will perform treatment, patients will be treated groupwise thereby allowing them to be in (eye) contact with their therapist at all times. Patients are not left alone with the needles inserted.
- Primary outcomeThe testbattery consists of the following: PSQI, Epworth, RST, BDI, PANSS, Sleep Diary, SF-36, MUPS, number recall (WAIS III), letter number recall (WAIS III), mwt-b.
Tests are filled in or taken in presence of a psychology apprentice. Statistical analysis are performed by an external expert who only receives the numbers. Patient data is kept anonymous at all times. Testing will take place pre and post treatment or waitlistcondition.
- Secondary outcomeFollowup test three months after post testing.
- Timepoints1. Pre and post treatment;
2. Pre and post waitlist condition;
3. Followup three months later.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Peggy Bosch
- CONTACT for SCIENTIFIC QUERIES Peggy Bosch
- Sponsor/Initiator LVR Klinik Bedburg Hau, Donders Institute for Brain, Cognition, and Behaviour, Centre for Cognition, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
LVR Klinik Bedburg Hau, Donders Institute for Brain, Cognition, and Behaviour, Centre for Cognition, Radboud University Nijmegen
- PublicationsFirst results (pre treatment) are in progress.
- Brief summaryIn this study, the effect of acupuncture on patients with schizophrenia or depression is being studied. Mostly effects on sleep, concentration, memory and affect are studied. This project is conducted in a clinic in Germany and is actually part of a cooperation with the Radboud University Nijmegen. Since it is one of the first studies in this field, the current study is seen as a large pilot that might form the basis for broader future research.
- Main changes (audit trail)
- RECORD2-nov-2011 - 21-nov-2011


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