Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study

Anorexia Nervosa Clinical Trial

Official title:

Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812950
• Other study ID #: NL80491.068.22
• Secondary ID: 60-63600-98-1131
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Maastricht University
• Contact: Jeffrey Roelofs, Dr.
• Phone: +31433881607
• Email: j . roelofs [@] maastricht university . nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

Behavioral:
• GST
Outpatient eating disorder treatment (5 individual pre-group sessions followed by 26 weekly group sessions + 8 optional individual sessions)
• CBT-E
Outpatient eating disorder treatment (20-40 weekly individual sessions)

Locations

Country	Name	City	State
Netherlands	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

Sponsors (9)

Lead Sponsor	Collaborator
Maastricht University	Accare, Co-eur, GGNet Amarum, GGZ Breburg, GGZ Friesland, University of Groningen, Utrecht University, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Childhood Trauma Questionnaire-Short Form (CTQ-SF)	This questionnaire consists of 28 questions measuring physical abuse, emotional abuse, sexual abuse, physical neglect and emotional neglect during childhood.	Baseline (Before start CBT-E)
Secondary	Change in Young Schema Questionnaire Short Form version 3 3 (YSQ-S3) score	The YSQ-S3 will be used to measure 18 early maladaptive schemas and is a valid instrument for the assessment of early maladaptive schemas in clinical and research settings.	Baseline (Before start CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
Secondary	Change in Schema Mode Inventory for Eating Disorders (SMI-ED) score	The SMI-ED will be used to assess schema modes that are relevant in patients with an eating disorder. It measures 5 maladaptive child modes, 2 maladaptive internalized/introject modes, 7 maladaptive coping modes, and 2 healthy factors.	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	Change in Brief Symptom Inventory (BSI) score	The BSI will be used to assess general psychological and physical symptoms	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	Change in Eating Disorder Quality of Life (EDQoL) score	Quality of life will be assessed using the EDQoL	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	Clinical Perfectionism Questionnaire (CPQ)	The CPQ will be used to assess clinical perfectionism. This questionnaire consists of 12 items that measure the level of self-evaluation based on striving towards extremely high personal standards despite adverse consequences.	Baseline (Before start CBT-E)
Secondary	Session Rating Scale (SRS)	Therapeutic alliance will be evaluated in each session using the patient-rated SRS, which is a short (four items) measure.	up to 39 weeks
Secondary	Quality of life and achievement personalized treatment goals	A qualitative interview (to be developed)	End of treatment (up to 39 weeks after randomization)
Secondary	Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)	Patient-reported productivity losses and multiple dimensions of healthcare resource consumption will be measured, using the validated TIC-P questionnaire. This questionnaire has been tested extensively for patients with a psychiatric disorder, using a recall period of three months. Using various unit prices in healthcare, both productivity losses and healthcare resource consumption will be valued monetarily in order to estimate the actual costs for the CBT-E arm and the GST arm within a closed time frame (Bouwmans et al., 2013).	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	Change in Quality-adjusted life years score	Five dimensions of quality of life will be measured, using the EQ-5D-5L questionnaire: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Participants will be asked to rank the extent to which they feel satisfied about these five dimensions on a 5-point Likert scale. Then they will be asked to rank their current health state, using a 0-100 VAS analog scale. Final utility scores from both the CBT-E arm and the GST arm on all dimensions of this questionnaire will be converted into a single health utility measure: Quality-adjusted life years or QALYs (Feng et al., 2021).	4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment