|- candidate number||8237|
|- NTR Number||NTR2415|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jul-2010|
|- Secondary IDs||P10-31 METC|
|- Public Title||Effectiveness of the online intervention Etendebaas.nl.|
|- Scientific Title||Randomised Controlled Trial on the effectiveness of the online intervention Etendebaas.nl for female patients with bulimia nervosa, binge eating disorder and eating disorder not otherwise specified.|
|- hypothesis||The online intervention Etendebaas.nl will effectively reduce disordered eating behaviour among female patients with BN, BED and EDNOS. |
|- Healt Condition(s) or Problem(s) studied||Eating disorders|
|- Inclusion criteria||1. Female;|
2. Minimum age of 18;
3. Diagnosis bulimia nervosa (BN), binge eating disorder (BED) or eating disorder not otherwise specified (EDNOS);
4. Access and ability to use the Internet;
5. Reading and writing the Dutch language;
6. Given informed consent.
|- Exclusion criteria||1. Body weight less than 85% of ideal weight; |
2. Receiving any other treatment for eating disorders during the past six months;
3. Current significant suicidal ideation;
5. Planned absence of 4 weeks or longer during treatment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||28-mrt-2011|
|- planned closingdate||1-dec-2014|
|- Target number of participants||252|
|- Interventions||In this randomised controlled trial patients will be randomised between the online intervention Etendebaas.nl (intervention group) or the waiting list control group.
Patients in the intervention group can immediately start with the online intervention. Etendebaas.nl is a structured treatment program consisting of two parts in which the patient and therapist communicate asynchronous, via the internet only. The patient and therapist are in separate locations and the interaction between them occurs with a delay between responses. The duration of the intervention varies between patients, but on average takes approximately 15 weeks. The aim of the intervention is to motivate patients to change their eating behaviour and body image, and to provide support for this change. The ultimate goal of treatment is a reduction in disordered eating behaviour. The program uses psycho-education and cognitive-therapeutic techniques. The method underlying the intervention is based on principles from the Cognitive Behaviour Therapy (CBT) and motivational interviewing. Part 1 of the intervention consists of at least seven contacts with four assignments; focusing on the analysis of the patients eating behaviour. A personal advice is given at the end of part 1. Part 2 consists of at least fourteen contacts with six assignments.
The waiting list control group receives an informational and supportive email once every two weeks during the waiting period. Patients cannot reply to these messages. These email messages include information about the website and forum of Etendebaas.nl, psycho-education, motivational messages and information related to eating disorders, such as the physical and mental symptoms.
|- Primary outcome||Reduction in disordered eating behaviour (Eating Disorder Examination Questionnaire EDE-Q; Fairburn & Beglin, 1994; Dutch translation: van Furth, 2000).|
|- Secondary outcome||1. Body dissatisfaction: Body Attitude Test (BAT; Dutch translation ‘Lichaamsattitude vragenlijst’- LAV);|
2. Physical health: MAP-HSS;
3. Mental Health: Depression Anxiety and Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995);
4. Self-esteem: Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965);
5. Quality of life: EuroQol-5D (EQ-5D; Lamers, Stalmeier, McDonnell, Krabbe, & Busschbach, 2005);
6. Social contacts: four dimensions of the MATE part 7 ‘Activities & Participation, Care & Support’ (Schippers, Broekman, & Buchholz, 2007): (1) interpersonal interactions and relationships, (2) important areas of life, (3) social life and (4) support and social surroundings;
7. Motivation for treatment: TCU Motivation for Treatment (MfT; De Weert-Van Oene, Schippers, De Jong, & Schrijvers, 2002);
8. Helping Alliance: Helping Alliance Questionnaire (HAQ; De Weert-Van Oene, De Jong, Jörg, & Schrijvers, 1999; Luborsky et al., 1996).
|- Timepoints||T0: Baseline;|
T1: Post-treatment (15 weeks);
T2: Follow-up 1 (3 months);
T3: Follow-up 2 (6 months);
T4: Follow-up 3 (one year).
|- Trial web site||www.etendebaas.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. E.D. Huurne, ter|
|- CONTACT for SCIENTIFIC QUERIES||MSc. E.D. Huurne, ter|
|- Sponsor/Initiator ||Tactus Verslavingszorg|
(Source(s) of Monetary or Material Support)
|- Brief summary||We aim to evaluate the effectiveness of Etendebaas.nl, an online intervention for female patients with bulimia nervosa, binge eating disorder and eating disorder not otherwise specified. We will conduct a randomised controlled trial with two groups: intervention group and waiting list control group. Patients in the intervention group can immediately start with the online intervention and patients in the control group have to wait 15 weeks before they can start the intervention.|
|- Main changes (audit trail)|
|- RECORD||14-jul-2010 - 9-mei-2012|