|- candidate number||22828|
|- NTR Number||NTR5451|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-sep-2015|
|- Secondary IDs||NL51113.042.15 METc UMCG|
|- Public Title||Online intervention for improving body satisfaction|
|- Scientific Title||Does body satisfaction improve in adolescents with an eating disorder due to an online training based on evaluative conditioning?|
|- hypothesis||The aim of this study is to investigate the effectiveness of a brief computer intervention to improve body satisfaction and self-esteem in a clinical population of adolescents with an eating disorder. We will examine whether the intervention is effective (a) in adolescents with an eating disorder and (b) as online intervention.|
|- Healt Condition(s) or Problem(s) studied||Eating disorders, Self concept|
|- Inclusion criteria||> Patients who are dissatisfied with their body and who would like to receive treatment for this|
> Patients who were diagnosed at the start of their treatment at usual with Anorexia Nervosa, Boulimia Nervosa or eatings disorder not otherwise specified
> Patients of 12 years or older can participate
> Only patients with a normal weight or slight overweight can participate (BMI adjusted to growth curve, "adjusted BMI" of 85 to 140, which is similar to a BMI of 18.5 to 30 in adults, Van Winckel & Van Mil, 2001). In case of anorexia nervosa this means that patients first should have gained weight.
|- Exclusion criteria||> Non-Dutch speaking patients|
> Patients who are no longer dissatisfied with their bodies
> Patients with obesity (adjusted BMI > 140)
> Patients with underweight (adjusted BMI < 85)
> Patients who do not want to be randomized
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2015|
|- planned closingdate||1-mrt-2017|
|- Target number of participants||51|
|- Interventions||This innovative computertraining is based on conditioning principles and learns participants to associate their body with positive, accepting social feedback.|
|- Primary outcome||The primary outcome measures of the study are body satisfaction measured with the:|
• Body Image States Scale (BISS)
• Subscales weight and shape concerns of the Eating Disorder Examination Questionnaire (EDE-Q)
• Automatic body evaluation measured with the Implicit Association Test (IAT)
And general self-esteem measured with the Rosenberg Self-Esteem Scale (RSES).
|- Secondary outcome||In addition, we study the effects of the intervention on general treatment success:|
• Severity of eating disorder symptoms measured with the total scores and subscales restraint and eating concerns of the EDE-Q.
• Positive aspects of body image measured with the short version of the Body Appreciation Scale (BAS).
• Social aspects of body image measured with the Perceptions of Social Approval for Appearance (PSAA).
• Tendency to social comparison measured with the Physical Appearance Comparison Scale (PACS).
• Ideal body image is measured with the Contour Drawing Rating Scale (CDRS).
|- Timepoints||Pre, post, 3 weeks FU, 11 weeks FU. For the control group there is an extra assessment after halve of the training.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. K. Glashouwer|
|- CONTACT for SCIENTIFIC QUERIES||Dr. K. Glashouwer|
|- Sponsor/Initiator ||Accare, Child-and adolescent psychiatry Centre for Eating disorders |
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||2-sep-2015 - 22-nov-2015|