Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study
2 other identifiers
interventional
230
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2023
CompletedFirst Posted
Study publicly available on registry
April 14, 2023
CompletedStudy Start
First participant enrolled
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 30, 2023
November 1, 2023
3.4 years
March 4, 2023
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Eating Disorder Examination Questionnaire (EDE-Q) score
Eating pathology will be measured with the Eating Disorder Examination Questionnaire (EDE-Q). Fairburn \& Beglin, 2008). 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.
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 (10)
Childhood Trauma Questionnaire-Short Form (CTQ-SF)
Baseline (Before start CBT-E)
Change in Young Schema Questionnaire Short Form version 3 3 (YSQ-S3) score
Baseline (Before start CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
Change in Schema Mode Inventory for Eating Disorders (SMI-ED) score
4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
Change in Brief Symptom Inventory (BSI) score
4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
Change in Eating Disorder Quality of Life (EDQoL) score
4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
- +5 more secondary outcomes
Study Arms (2)
Group Schema Therapy for eating disorders (GST)
EXPERIMENTALGST starts with 5 individual sessions for introducing the ST model, placing the ED symptoms and behaviors in the context of coping modes, and organizing these in a mode map conceptualization. Thereafter there are 26 weekly group sessions of ST for EDs, supplemented with 8 optional individual ST sessions, and a psycho-education webinar for relatives. The sessions focus on recognizing and changing personal coping modes and underlying early maladaptive schemas, and developing and strengthening the healthy adult mode. GST combines interpersonal, experiential, cognitive and behavioral elements in a unified ST approach (Farrell et al., 2014). 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. Note that the participants in this condition have followed phase 1 and 2 of CBT-E before starting the GST, as following these phases is required to be included in the RCT.
Cognitive Behavioral Therapy-Enhanced (CBT-E) (TAU)
ACTIVE COMPARATORThis 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 shape, weight, and eating, dietary restraint or restriction, being underweight, and event- or mood-triggered changes in eating behaviour), are targeted, and a relapse plan is created. Phase four focuses on evaluating the progress so far and maintaining the changes that have been obtained (Fairburn et al., 2009).
Interventions
Outpatient eating disorder treatment (5 individual pre-group sessions followed by 26 weekly group sessions + 8 optional individual sessions)
Outpatient eating disorder treatment (20-40 weekly individual sessions)
Eligibility Criteria
You may qualify if:
- \) age \> 16 years;
- \) 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).
You may not qualify if:
- \) not being able to speak and read the Dutch language;
- \) being in an acute psychotic mental health state at the start of the study;
- \) being diagnosed with an autism spectrum disorder;
- \) having an IQ below 80, as determined with a validated instrument;
- \) showing an early response after phase 1 of CBT-E.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht Universitylead
- Utrecht Universitycollaborator
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- GGNet Amarumcollaborator
- GGZ Breburgcollaborator
- Accarecollaborator
- Co-eurcollaborator
- GGZ Frieslandcollaborator
- University of Groningencollaborator
Study Sites (7)
GGz Breburg
Breda, Netherlands
Accare
Groningen, Netherlands
GGZ Friesland
Leeuwarden, Netherlands
GGNet Amarum
Nijmegen, Netherlands
GGz Breburg
Tilburg, Netherlands
Co-eur
Utrecht, Netherlands
GGNet Amarum
Warnsveld, Netherlands
Related Publications (1)
Mares SHW, Roelofs J, Zinzen J, Beatse M, Elgersma HJ, Drost RMWA, Evers SMAA, Elburg AAV. Clinical effectiveness, cost-effectiveness and process evaluation of group schema therapy for eating disorders: study protocol for a multicenter randomized controlled trial. BMC Psychol. 2024 Mar 4;12(1):123. doi: 10.1186/s40359-024-01624-w.
PMID: 38439092DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Roelofs
Maastricht University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Once data collection is complete, the data will be blinded by one of the principal investigators. This allows for blinded analysis by the outcome assessor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator J. Roelofs, PhD
Study Record Dates
First Submitted
March 4, 2023
First Posted
April 14, 2023
Study Start
July 24, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share