Clinical trial NCT05812950: Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study
Official title: Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Atypical Anorexia Nervosa (Other Specified Eating Disorder)
Bulimia Nervosa
Atypical Bulimia Nervosa (Other Specified Eating Disorder)
Keywords: CBT-E
Group Schema Therapy
Eating disorders
Effectiveness
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Utrecht University
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: GGNet Amarum
name: GGZ Breburg
name: Accare
name: Co-eur
name: GGZ Friesland
name: University of Groningen
First posted: 2023-04-14
Enrollment: 230
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants start with CBT-E phase 1 and 2. If not improved enough with regard to eating disorder symptoms (following EDE-Q pre- and post measure comparison) in the first phase, they will be included in the RCT. When included they will be randomly assigned to either the CBT-E continuation condition or the GST condition.
Primary purpose: TREATMENT

Brief summary: Amongst psychiatric illnesses, eating disorders (EDs) are notoriously difficult to treat and have a high mortality rate. The average duration of an ED is 6 years and for a majority of ED patients, the disorder will become chronic. Comorbid personality pathology such as negative core beliefs and early maladaptive schemas (EMS) are strongly related to ED severity and chronicity. Enhanced cognitive-behavioural therapy for eating disorders (CBT-E) is used as the first line transdiagnostic treatment for EDs. However, CBT-E is mainly symptom-focused and does not tap into these underlying core beliefs and EMS.

Given the limited treatment effects of existing ED treatments, and the importance of comorbid personality pathology, there is an urgent need to examine more effective treatments for EDs. Group-schematherapy (GST) overcomes the limitations of CBT-E and preliminary results for treatment-resistant EDs are promising. However, robust evidence regarding the clinical and cost-effectiveness of GST for patients that do not benefit from CBT-E is not yet available. The central aim of this project is to investigate the clinical and cost-effectiveness of GST for EDs in patients with comorbid personality pathology, who do not show a clinically significant response in the first phase of CBT-E. This is relevant and important as studies examining the effectiveness of GST for EDs are scarce. This project is a joint research initiative of three academic centers (Dutch Universities), four large nation-wide mental health organizations, and two foundations for client empowerment and participation. Eligible patients will be randomized to either GST or continuation of their CBT-E treatment after failing to show a significant treatment response in the first phase of CBT-E. Based on encouraging findings from previous studies and our own pilot data, a statistically and clinically significant better outcome in terms of ED symptoms, negative core beliefs, EMS, schema modes, and quality of life is expected in the GST group compared to the CBT-E group. GST is also expected to be more cost-effective compared to CBT-E as GST may in the long run prevent chronicity in terms of long treatment trajectories and delayed recovery. Finally, with the proviso of good results for GST, we will disseminate and implement GST in the standard of care for EDs. This project thereby has great potential to improve clinical and cost-effectiveness of treatment for chronic EDs.


Eligibility criteria: 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).

Exclusion Criteria:

* 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;
* 5) showing an early response after phase 1 of CBT-E.

Primary outcomes:
measure: Change in Eating Disorder Examination Questionnaire (EDE-Q) score
timeFrame: Baseline (Before start CBT-E), 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
Secondary outcomes:
measure: Childhood Trauma Questionnaire-Short Form (CTQ-SF)
timeFrame: Baseline (Before start CBT-E)
measure: Change in Young Schema Questionnaire Short Form version 3 3 (YSQ-S3) score
timeFrame: Baseline (Before start CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
measure: Change in Schema Mode Inventory for Eating Disorders (SMI-ED) score
timeFrame: 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
measure: Change in Brief Symptom Inventory (BSI) score
timeFrame: 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
measure: Change in Eating Disorder Quality of Life (EDQoL) score
timeFrame: 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
measure: Clinical Perfectionism Questionnaire (CPQ)
timeFrame: Baseline (Before start CBT-E)
measure: Session Rating Scale (SRS)
timeFrame: up to 39 weeks
measure: Quality of life and achievement personalized treatment goals
timeFrame: End of treatment (up to 39 weeks after randomization)
measure: Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)
timeFrame: 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
measure: Change in Quality-adjusted life years score
timeFrame: 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: GGz Breburg
city: Groningen
country: Netherlands
facility: Accare
city: Leeuwarden
country: Netherlands
facility: GGZ Friesland
city: Nijmegen
country: Netherlands
facility: GGNet Amarum
city: Tilburg
country: Netherlands
facility: GGz Breburg
city: Utrecht
country: Netherlands
facility: Co-eur
city: Warnsveld
country: Netherlands
facility: GGNet Amarum
Study officials:
affiliation: Maastricht University
name: Jeffrey Roelofs
role: PRINCIPAL_INVESTIGATOR
References: