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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR3382 |
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Date of registration:
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05/04/2012 |
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Primary sponsor: |
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Public title:
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Psychomotor therapy and aggression regulation in eating disorders.
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Scientific title:
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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. -
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Date of first enrolment:
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23/11/2009 |
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Target sample size:
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72 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3382 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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C.
Boerhout |
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Address:
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Einthovenlaan 39
9728 LV
Groningen
The Netherlands |
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Telephone:
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+31 (0)6 13761706 |
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Email:
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boerhoutjol@home.nl |
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Affiliation:
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Name:
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J.T.
Busschbach, van |
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Address:
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University Medical Center Groningen (UMCG), Rob Giel Research Center,
P.O. Box 30001, Hanzeplein 1
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3612069 |
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Email:
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j.t.van.busschbach@med.umcg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Impulsivity, Eating disorders, Anorexia, Bulimia, Anger problems
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Intervention(s)
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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).
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Primary Outcome(s)
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1. Coping with aggression: Changes in the degree of internalisation and externalisation of aggression (SECS);
2. Appraisal of the module (satisfaction scale).
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Secondary Outcome(s)
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1. Eating behavior and attitudes (EDE-Q);
2. General functioning (OQ-45).
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Source(s) of Monetary Support
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Lentis
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