An interventional study of GST and CBT-E in Anorexia Nervosa, Atypical Anorexia Nervosa (Other Specified Eating Disorder) and Bulimia Nervosa, sponsored by Maastricht University. Recruiting at 7 sites in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Maastricht University · Not applicable, Interventional, and Treatment
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.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 230 is above the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →Maastricht University is the lead sponsor of 97 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GST 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.
Behavioral: GST
This 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).
Behavioral: CBT-E
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)
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.
Time frame: 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
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.
Time frame: Baseline (Before start CBT-E)
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.
Time frame: 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
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.
Time frame: 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
The BSI will be used to assess general psychological and physical symptoms
Time frame: 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
Quality of life will be assessed using the EDQoL
Time frame: 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
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.
Time frame: Baseline (Before start CBT-E)
Session Rating Scale (SRS)
Therapeutic alliance will be evaluated in each session using the patient-rated SRS, which is a short (four items) measure.
Time frame: up to 39 weeks
Quality of life and achievement personalized treatment goals
A qualitative interview (to be developed)
Time frame: End of treatment (up to 39 weeks after randomization)
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).
Time frame: 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 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).
Time frame: 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
Plan to share: No
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Started Jul 2023 (actual). Primary completion is estimated for Dec 2026, 41 months after the start.
Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 41 months is close to that.
Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.
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