Actively Recruiting
Led by Maastricht University · Updated on 2023-11-30
230
Participants Needed
7
Research Sites
N/A
Total Duration
M
Maastricht University
Lead Sponsor
U
Utrecht University
Collaborating Sponsor
Eating disorders (EDs) are challenging psychiatric conditions with high mortality and often become chronic, lasting an average of six years. Comorbid personality issues like negative core beliefs and early maladaptive schemas (EMS) are strongly linked to the severity and persistence of EDs. While cognitive-behavioral therapy enhanced (CBT-E) is the standard first-line treatment focusing on symptoms, it does not address these underlying personality factors. This study aims to evaluate the clinical and cost-effectiveness of group schema therapy (GST) for ED patients with comorbid personality pathology who do not respond significantly to the initial phase of CBT-E, addressing a crucial gap in treatment options. Participants who have completed the first two phases of CBT-E but show limited improvement will be randomized to either continue CBT-E or start GST. GST begins with five individual sessions introducing the schema therapy model and organizing coping modes, followed by 26 weekly group sessions and up to eight optional individual sessions. A psycho-education webinar for relatives is also included. GST focuses on changing personal coping modes and early maladaptive schemas while supporting healthy adult mode development. CBT-E involves 20 to 40 weekly individual therapy sessions across four phases, targeting eating behavior patterns and relapse prevention. Throughout the study, participants will be assessed at multiple time points before, during, and after treatment, including up to 12 months post-treatment. Evaluations include questionnaires measuring eating disorder symptoms, schema-related beliefs, symptom inventories, quality of life, and treatment costs. These assessments aim to track changes in ED severity, personality pathology, and overall well-being. The study intends to provide evidence on whether GST offers better clinical outcomes and cost benefits compared to continued CBT-E, potentially influencing future standard care for chronic eating disorders.
CONDITIONS
Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 39 weeks
Participants receive outpatient behavioral treatment for eating disorders. Group Schema Therapy (GST) includes 5 individual pre-group sessions, followed by 26 weekly group sessions and up to 8 optional individual sessions. Cognitive Behavioral Therapy-Enhanced (CBT-E) involves 20 to 40 weekly individual sessions.
Weekly visits for 20 to 40 weeks depending on assigned treatment
Duration - Up to 12 months after end of treatment
Participants are monitored for treatment outcomes and changes in symptoms for up to 12 months after treatment ends.
Visits at 6 and 12 months after treatment completion
Total: 7 locations
1
GGz Breburg
Breda, Netherlands
Actively Recruiting
2
Accare
Groningen, Netherlands
Actively Recruiting
3
GGZ Friesland
Leeuwarden, Netherlands
Actively Recruiting
4
GGNet Amarum
Nijmegen, Netherlands
Actively Recruiting
5
GGz Breburg
Tilburg, Netherlands
Actively Recruiting
6
Co-eur
Utrecht, Netherlands
Actively Recruiting
7
GGNet Amarum
Warnsveld, Netherlands
Actively Recruiting
J
Jeffrey Roelofs, Dr.
S
Suzanne Mares, Dr.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Suzanne H W Mares, Jeffrey Roelofs, Janôt Zinzen...
https://pubmed.ncbi.nlm.nih.gov/38439092