Psychological treatment of Eating Disorders:
A multi-centered randomized controlled trial on the
(cost-)effectiveness of Enhanced Cognitive Behavior Therapy (CBT-E)
Titel for patients: Effectiveness study on the therapy of eating disorders

Currently, cognitive behavior therapy (CBT) is the treatment of first choice
according to the Dutch Multidisciplinary Guideline
Eating Disorders (2006). Effectiveness studies of CBT are scarce, especially in
the Netherlands. International research focused
on relatively small categories of EDs (BN or BED). Thus the evidence for this
treatment needs to be expanded.
Fairburn developed a relatively short (20 sessions in 20 weeks) transdiagnostic
version of CBT, CBT-E(nhanced), designed
to be suitable for the full range of ED diagnoses. It is based upon the
transdiagnostic theory of the maintenance of EDs in
which it is held that most of the mechanisms involved in the persistence of EDs
are common to all three EDs rather than being
peculiar to any one diagnostic group. According to Fairburn, EDs have more
similarities than differences, especially the core
psychopathology (over-evaluation of shape and weight) and expression in
attitudes and behavior. CBT-E, the enhanced
version of CBT, uses new strategies and procedures to address mechanisms that
are central to the maintenance of EDs (e.g.,
procedures directed at over-evaluation of shape and weight).

The objective of this project is to assess whether CBT-E is more optimal in
terms of (cost-)effectiveness than TAU in the
treatment of outpatients with an ED. The results of this study will provide
evidence whether or not CBT-E should be delivered to
patients with a broad range of ED diagnoses.
We expect that CBT-E will be preferred over TAU in terms of:
* Direct clinical effectiveness:
o higher percentage of recovery from ED (SCID-I)
* Indirect clinical effectiveness:
o improvement in eating disorder psychopathology
o improved health related quality of life
o improvement in related problem areas (self-esteem, depression)
* Direct costs:
o lower number of mental health care contacts and consequently treatment costs
o lower utilization of other health care and consequently costs
o less direct costs outside the health care e.g. travel and waiting time,
out-of-pocket expenditures
* Indirect costs:
o less absence from work
o less reduced efficiency
o less burden to the caregiver
*Mediating effects:
o Self-esteem, perfectionism and interpersonal problems can be determined as
mediators for the effect of the treatment

Multi-centre RCT. The study will be performed at three specialized Eating
disorder treatment centers: PsyQ The Hague (Parnassia Psychiatric Institute),
PsyQ Groningen (Lentis), Rintveld (Altrecht). 140 Patients meeting in/exclusion
criteria are randomly allocated to TAU or CBT-E. Allocation of the patient is
done by a central independent research assistant after screening and checking
the in/exclusion criteria and signing of the informed consent. Repeated
assessments are carried out pre treatment (T0), after session 9 CBT-E/5 weeks
after start of treatment TAU (T1), post treatment CBT-E/20 weeks after start of
treatment TAU (T2), at 20 weeks follow up CBT-E/40 weeks after start of
treatment TAU (T3) and at 60 weeks follow up CBT-E/80 weeks after start
treatment TAU (T4). Before start of treatment, at T2 and T4 the structural
interview (SCID-I) is carried out to obtain the eating disorder diagnosis. To
assess treatment integrity and competence, a random sample of audio taped
sessions will be assessed by independent raters.

CBT-E versus TAU. TAU is the usual treatment given at the site. Depending on
the site*s treatment policy, this may vary from low intensity care to high
intensity care. The type of treatment provided is registered.

No risks are associated with participation. The burden of the research will be
5 assessments of 60 minutes during 80 weeks and three structured interviews for
the eating disorder diagnosis (duration 15 minutes). These assessments consist
of 10 questionnaires, which the participants can fill in at home at a computer,
the interviews will be done by telephone. No benefits are associated with
participation, only enhancement of the scientific knowledge.