|- candidate number||12204|
|- NTR Number||NTR3382|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-apr-2012|
|- Secondary IDs|| |
|- Public Title||Psychomotor therapy and aggression regulation in eating disorders.|
|- Scientific Title||Randomized controled study on the effect of a psychomotor therapy protocol for aggressionregulation, regarding externalization and internalization in patients with eating disorders, within an outpatient and daycare setting.|
|- hypothesis||The module aggression regulation is expected to have a positive effect on the regulation of aggression and, via this, also on eating behavior and general functioning. |
|- Healt Condition(s) or Problem(s) studied||Impulsivity, Eating disorders, Anorexia, Bulimia, Anger problems|
|- Inclusion criteria||Diagnosis according to DSM-IV criteria:|
1. Anorexia Nervosa;
2. Bulimia Nervosa;
3. Eating Disorder Not Otherwise Specified (NOS).
|- Exclusion criteria||1. Mental retardation (IQ lower than 70);|
2. Acute psychosis or crisis.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-nov-2009|
|- planned closingdate||1-jan-2014|
|- Target number of participants||72|
|- Interventions||For the daycenter:|
'Treatment-as-usual’ (TAU) lasts 6-9 months and is multidisciplinary in nature. Patients follow a 4-day program. The module aggression regulation is a regular part of this program, but is only offered to 2 patients at a time (TAU + module: condition A). The other patients follow the regular program (only TAU: condition B). The module consists of 6 weekly sessions of 1 hour.
If time allows, patients in the control condition may follow the module later on, after a waiting period.
For the outpatient clinic:
Regularly patients with eating disorders will be offered a diet-group but this group only starts after 6-7 weeks. The module will be offered during this waitingperiod. One group will follow the module and afterward the dietgroup (Module+ TAU; group A), one group will enter the dietgroup after the regular waitingperiod (waitingperiod + TAU; group B).
|- Primary outcome||1. Coping with aggression: Changes in the degree of internalisation and externalisation of aggression (SECS);|
2. Appraisal of the module (satisfaction scale).
|- Secondary outcome||1. Eating behavior and attitudes (EDE-Q);|
2. General functioning (OQ-45).
|- Timepoints||For the daycenter: |
At start TAU, after 2 months (randomization and start intervention), after 4 months (end of the intervention), after 6-9 months (end TAU).
For the outpatient setting:
At start inervention after intake, after 2 months (end of intervention), after 3-5 months (end dietgroup).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| C. Boerhout|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.T. Busschbach, van|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Publications||Boerhout, C., Van Busschbach, J. T., Wiersma, D., & Hoek, H. W. (2011). Do we need to treat aggression? (In reply letter). The British Journal of Psychiatry, 198, 408a. doi:10.1192/bjp.198.5.408a|
|- Brief summary||The purpose of this study is to support the need to address anger and aggression in evidence-based treatment of eating disorders and to introduce psychomotor therapy as a body oriented therapy for aggression regulation. The ultimate goal is to accelerate the overall process of (multidisciplinary) treatment by triggering a functional self-expression.|
|- Main changes (audit trail)|
|- RECORD||5-apr-2012 - 15-apr-2012|