The (cost-) effectiveness of an internet intervention for eating disorders.|
|- candidate number||13400|
|- NTR Number||NTR3646|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-okt-2012|
|- Secondary IDs||40085 ABR|
|- Public Title||The (cost-) effectiveness of an internet intervention for eating disorders.|
|- Scientific Title||An internet-based intervention for the prevention and (early) intervention of eating disorders:
A randomized controlled trial investigating the (cost-) effectiveness of computer-tailored feedback with or without supplemented frequent or infrequent e-mail, chat, or Skype support from a coach.|
|- hypothesis||1. The intervention is effective in reducing eating disorder symptoms;|
2. There is an incremental effect of intensive/frequent support from a coach in terms of reducing ED symptoms.
|- Healt Condition(s) or Problem(s) studied||Eating disorders|
|- Inclusion criteria||1. Aged 16 years or older;|
2. At least having some (mild) forms of eating disorder symptoms, or at least having some risk for the development of an eating disorder;
3. Access to a computer, iPhone, Ipad, Smartphone or laptop with an internet connection.
|- Exclusion criteria||None.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2012|
|- planned closingdate||1-apr-2015|
|- Target number of participants||344|
|- Interventions||Condition 1: Basic Featback.|
Participants receive access to the website of Featback (www.Featback.nl), where comprehensive information on eating disorders can be found (e.g. psycho education). Furthermore, participants can access a monitoring and feedback system. At a weekly basis, participants receive an e-mail reminding them to complete the monitoring questionnaire, which consists of eight items assessing cognitive and behavioral correlates of the following four dimensions: 1) body dissatisfaction, 2) over concern with body weight and shape, 3) unbalanced nutrition and dieting, and 4) binge eating and compensatory behaviors. After completion of the monitoring assessment, feedback messages are automatically generated according to a pre-defined algorithm. The feedback messages are individually tailored. That is, they are based on the functionality of reported eating disorder related attitudes and behaviors (functional versus dysfunctional), as well as patterns of change (improved, deteriorated or unchanged).
Condition 2: Basic Featback + Infrequent support.
Participants in this condition will receive the basic Featback intervention as described above, supplemented with the possibility of infrequent, weekly e-mail, chat or Skype support from a coach.
Condition 3: Basic Featback + Frequent support.
Participants in this condition will receive the basic Featback intervention as described above, supplemented with the possibility of frequent, three-weekly e-mail, chat or Skype support from a coach.
Condition 4: Waiting List Control (WLC).
|- Primary outcome||Eating disorder related behaviors and attitudes, measured with online surveys.|
|- Secondary outcome||1. Eating disorder-related quality of life;|
2. Self-stigma of seeking help;
3. Self-esteem, mastery and support;
4. Symptoms of depression and anxiety;
5. Repetitive negative thinking;
6. Motivation to change;
7. User satisfaction;
9. Help-seeking attitudes and behaviors;
10. Medical and societal costs.
|- Timepoints||T0: Baseline;|
T1: Post-intervention (8 weeks after T0);
T2: 3-month follow-up (3 months after T1);
T3 (not for participants in the waiting list control condition): 6-month follow-up (6 months after T1).
|- Trial web site||Www.featback.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. E.F. Furth, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. E.F. Furth, van|
|- Sponsor/Initiator ||Rivierduinen, Center for Eating Disorders Ursula|
(Source(s) of Monetary or Material Support)
|Center for Eating Disorders Ursula (Rivierduinen) |
|- Brief summary||New technologies may be able to bridge the gap between the need and actual treatment received, providing opportunities to reach individuals who would otherwise be hard to reach. ‘Featback’ is an internet-based program that has been developed for the prevention and (early) intervention of eating disorders. It exists of several components (psycho education, a fully automated monitoring and feedback system, support from a psychologist), which can be matched according to participants’ needs and preferences.
The primary objective of this study is to examine the relative effectiveness of (the different components of) Featback.
The secondary objective is to examine predictors, moderators and mediators of intervention responses.
The third objective is to report on practical experiences with Featback, such as the user satisfaction and the (intensity of) use of the different components.
The fourth objective is to examine the cost-effectiveness of Featback.
Individuals aged 16 years or older , with mild to severe eating disorder symptoms will be randomized to one of the four intervention conditions. In condition one, participants will receive the basic version of Featback, which consists of psycho education and the fully automated monitoring and feedback system. In condition two, participants will receive the basic version of Featback supplemented with the possibility of infrequent (once a week) e-mail, chat, or Skype support from a coach. In condition three, participants will receive the basic version of Featback supplemented with the possibility of frequent (three-weekly) e-mail, chat, or Skype support from a coach.
Participants in condition one, two or three will be assessed prior to the intervention (T0), post-intervention (T1), and at 3- (T2) and 6-month follow-up (T3). The fourth condition is a waiting list control (WLC), in which participants will be assessed prior to their waiting period (T0), as well as after three (T1) and after five months (T2) of waiting. Hereafter, they will be offered the intervention of condition two.
Main study parameters:
Primary outcome measures are eating disorder related behaviors and attitudes. Secondary outcome measures are eating disorder related quality of life, self-stigma of seeking help, self-esteem, mastery and support, symptoms of depression and anxiety, repetitive negative thinking, motivation to change, user satisfaction, compliance, and help-seeking attitudes and behaviors.
|- Main changes (audit trail)|
|- RECORD||2-okt-2012 - 21-feb-2013|
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