NCT05812950 Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study
| NCT ID | NCT05812950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2023-07-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2023-07-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Jeffrey Roelofs
PRINCIPAL INVESTIGATOR
Maastricht University
Frequently Asked Questions
Who can join the NCT05812950 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05812950 currently recruiting?
Yes, NCT05812950 is actively recruiting participants. Contact the research team at j . roelofs @ maastricht university . nl for enrollment information.
Where is the NCT05812950 trial being conducted?
This trial is being conducted at Breda, Netherlands, Groningen, Netherlands, Leeuwarden, Netherlands, Nijmegen, Netherlands and 3 additional locations.
Who is sponsoring the NCT05812950 clinical trial?
NCT05812950 is sponsored by Maastricht University. The principal investigator is Jeffrey Roelofs at Maastricht University. The trial plans to enroll 230 participants.