Clinical and cost-effectiveness of group schema therapy for complex eating disorders: the GST-EAT study

Not yet recruiting

• Conditions: eetstoornissen (anorexia nervosa, boulimia nervosa en overige eetstoornissen); Eating disorder; Eating problem

• Registration Number: NL-OMON51433
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 230

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are eating disorder pathology and incremental<br /><br>cost-effectiveness ration (ICER) after treament. Eating disorder pathology is<br /><br>measured with the Eating Disorder Examination Questionnaire (EDE-Q [13]). This<br /><br>self-report measure is the most commonly used routine outcome measure in ED<br /><br>facilities in the Netherlands to measure the severity of the ED. ICER is<br /><br>assessed by taking into account the annual costs of both treatment and the<br /><br>follow-up effects for both treatments. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are differences between the CGT-E and GST conditions<br /><br>on quality of life, core cognitions, psychological well-being, clinical<br /><br>perfectionism, and the therapeutic relation. </p><br>