Group Schema Therapy for Complex Eating Disorders
Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study
NA · Maastricht University · NCT05812950
This study is testing a new group therapy called Group Schema Therapy to see if it can help people with complex eating disorders like anorexia and bulimia feel better when other treatments haven't worked.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Maastricht University (other) |
| Locations | 7 sites (Breda and 6 other locations) |
| Trial ID | NCT05812950 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical and cost-effectiveness of Group Schema Therapy (GST) for individuals suffering from complex eating disorders, including anorexia nervosa and bulimia nervosa. It aims to address the limitations of traditional cognitive-behavioral therapy by focusing on underlying personality pathology and maladaptive schemas that contribute to the severity and chronicity of these disorders. Participants will receive GST in a group setting, which is designed to enhance treatment outcomes for those who have not responded adequately to existing therapies. The study will assess both the clinical efficacy and the economic implications of implementing GST compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged over 16 with a DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or other specified eating disorders.
Not a fit: Patients who may not benefit from this study include those with acute psychotic states, autism spectrum disorders, or those who do not meet the language and cognitive requirements.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with complex eating disorders, potentially leading to improved recovery rates.
How similar studies have performed: Preliminary results from other studies on Group Schema Therapy for treatment-resistant eating disorders have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Breda and 6 other locations
- GGz Breburg — Breda, Netherlands (RECRUITING)
- Accare — Groningen, Netherlands (RECRUITING)
- GGZ Friesland — Leeuwarden, Netherlands (RECRUITING)
- GGNet Amarum — Nijmegen, Netherlands (RECRUITING)
- GGz Breburg — Tilburg, Netherlands (RECRUITING)
- Co-eur — Utrecht, Netherlands (RECRUITING)
- GGNet Amarum — Warnsveld, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Jeffrey Roelofs — Maastricht University
- Study coordinator: Jeffrey Roelofs, Dr.
- Email: j . roelofs @ maastricht university . nl
- Phone: +31433881607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anorexia Nervosa, Atypical Anorexia Nervosa, Bulimia Nervosa, Atypical Bulimia Nervosa, CBT-E, Group Schema Therapy, Eating disorders, Effectiveness