Eating disorder
Conditions
Interventions
Investigational treatment - GST
This treatment consists of 26 weekly group sessions of ST for EDs, supplemented 
with 8 individual ST sessions, and a psycho-education webinar for parents, 
family members, and/or partners. The individual sessions can be used for 
imagery rescripting of adverse childhood experiences. The first 5 sessions of 
the GST focus on explaining the ST model, placing the ED symptoms and 
behaviours in the context of coping modes, and organizing these in a mode map 
conceptualization. The following sessions focus on recognising and changing 
personal coping modes and underlying early maladaptive schema*s, and developing 
and strengthening the healthy adult mode. GST combines interpersonal, 
experiential, cognitive and behavioural elements in a unified ST approach. 
Although not at the core of GST, addressing the physiological aspects of the ED 
(weight care and (restrictive) eating) is necessary and therefore also 
incorporated in the protocol.
Active control intervention - CBT-E
This transdiagnostic ED treatment (current standard of care/treatment of 
choice) consists of 20-40 individual therapy sessions, based on the 
transdiagnostic CBT model of EDs. CBT-E consists of four phases. In phase one, 
the patient creates a personal case formulation, and the focus is on 
psycho-education on maintaining factors and at starting well with monitoring 
eating behaviours and establishing a regular eating pattern. In phase two, the 
first phase is evaluated and a treatment plan is made. In phase three, the main 
mechanisms that are thought to maintain the patient*s ED (over-evaluation of 
Sponsors
Universiteit Maastricht
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients who are in CBT-E treatment at one of the participating ED centers will be eligible for inclusion in the RCT if they fulfil the following inclusion criteria: 1) age > 16 years; 2) A DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or other specified ED (atypical anorexia nervosa or bulimia nervosa with a low frequency or limited duration); 3) failure to show an early response after phase 1 of CBT-E. Early response to CBT-E is measured with the Eating Disorder Examination Questionnaire (see outcome measures). The reliable change index will be used to assess whether a patient shows and early response to CBT-E.
Exclusion criteria
Exclusion criteria: Exclusion criteria are 1) not being able to speak and read the Dutch language; 2) being in an acute psychotic mental health state at the start of the study 3) being diagnosed with an autism spectrum disorder 4) having an IQ below 80, as determined with a validated instrument, and 5) showing an early response after phase 1 of CBT-E.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are eating disorder pathology and incremental cost-effectiveness ration (ICER) after treament. Eating disorder pathology is measured with the Eating Disorder Examination Questionnaire (EDE-Q). This self-report measure is the most commonly used routine outcome measure in ED facilities in the Netherlands to measure the severity of the ED. ICER is assessed by taking into account the annual costs of both treatment and the follow-up effects for both treatments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are differences between the CBT-E and GST conditions on quality of life, core cognitions, psychological well-being, clinical perfectionism, and the therapeutic relationship. Participants (who give consent to be invited to follow-up reserach) will be invited to take part in a qualitative interview discussing their experiences with therapy and their quality of life post-therapy. | — |
Countries
Netherlands
Contacts
Public ContactJ. Roelofs
Universiteit Maastricht
Outcome results
None listed