Anorexia NervosaNCT05812950
Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study
A study testing GST and CBT-E in people with Anorexia Nervosa and Atypical Anorexia Nervosa (Other Specified Eating Disorder), run by Maastricht University at 7 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anorexia Nervosa, Atypical Anorexia Nervosa (Other Specified Eating Disorder), Bulimia Nervosa
- What is being tested?
- GST and CBT-E
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 7 sitesNetherlands
- Study dates
- 24 Jul 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Recruiting
GGz Breburg
Breda
Diede van Limpt, 088-0161600, d.vanlimpt@ggzbreburg.nl
- Recruiting
Accare
Groningen
Hermien Elgersma, h.j.elgersma@accare.nl
- Recruiting
GGZ Friesland
Leeuwarden
Jacqueline Oostenbrink, Jacqueline.Oostenbrink@ggzfriesland.nl
- Recruiting
GGNet Amarum
Nijmegen
suzanne Mares, dr., +31625743442, s.mares@ggnet.nl
- Recruiting
GGz Breburg
Tilburg
Diede van Limpt, 088-0161600, d.vanlimpt@ggzbreburg.nl
- Recruiting
Co-eur
Utrecht
Esther Jansen, Esther.Jansen@co-eur.com
- Recruiting
GGNet Amarum
Warnsveld
Suzanne Mares, dr., +31625743442, s.mares@ggnet.nl
About this study
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.
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa (Other Specified Eating Disorder), Bulimia Nervosa, Atypical Bulimia Nervosa (Other Specified Eating Disorder)
- Being tested
- GST, CBT-E
- Keywords
- CBT-E, Group Schema Therapy, Eating disorders, Effectiveness
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSTBehavioural
Outpatient eating disorder treatment (5 individual pre-group sessions followed by 26 weekly group sessions + 8 optional individual sessions)
CBT-EBehavioural
Outpatient eating disorder treatment (20-40 weekly individual sessions)
| Study group | Role | What they receive |
|---|---|---|
| Group Schema Therapy for eating disorders (GST) | Experimental | 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. Receives: Behavioral: GST |
| Cognitive Behavioral Therapy-Enhanced (CBT-E) (TAU) | Active comparator | 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). Receives: Behavioral: CBT-E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: up to 39 weeks
Quality of life and achievement personalized treatment goals
A qualitative interview (to be developed)
Measured: 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).
Measured: 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).
Measured: 4 weeks (8 sessions CBT-E), end of treatment (up to 39 weeks after randomization), and 6 and 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start24 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants start with CBT-E phase 1 and 2. If not improved enough with regard to eating disorder symptoms (following EDE-Q pre- and post measure comparison) in the first phase, they will be included in the RCT. When included they will be randomly assigned to either the CBT-E continuation condition or the GST condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University, ZonMw: The Netherlands Organisation for Health Research and Development, GGNet Amarum, GGZ Breburg, Accare, Co-eur, GGZ Friesland, University of Groningen
- Responsible party
- Principal investigator, Jeffrey Roelofs, Maastricht University
- Investigators
- Jeffrey Roelofs, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812950
- Sponsor's protocol ID
- NL80491.068.22
- Other IDs
- 60-63600-98-1131
- Status last verified
- Nov 2023
- First submitted
- 4 Mar 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mares SHW, Roelofs J, Zinzen J, Beatse M, Elgersma HJ, Drost RMWA, Evers SMAA, Elburg AAV. Clinical effectiveness, cost-effectiveness and process evaluation of group schema therapy for eating disorders: study protocol for a multicenter randomized controlled trial. BMC Psychol. 2024 Mar 4;12(1):123. doi: 10.1186/s40359-024-01624-w.
PubMed 38439092
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study
- ClinicalTrials.gov ID
- NCT05812950
- Acronym / sponsor ID
- NL80491.068.22
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa (Other Specified Eating Disorder), Bulimia Nervosa, Atypical Bulimia Nervosa (Other Specified Eating Disorder)
- Keywords
- CBT-E, Group Schema Therapy, Eating disorders, Effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Utrecht University, ZonMw: The Netherlands Organisation for Health Research and Development, GGNet Amarum, GGZ Breburg, Accare, Co-eur, GGZ Friesland, University of Groningen
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants start with CBT-E phase 1 and 2. If not improved enough with regard to eating disorder symptoms (following EDE-Q pre- and post measure comparison) in the first phase, they will be included in the RCT. When included they will be randomly assigned to either the CBT-E continuation condition or the GST condition.
| Arm | Type | Receives |
|---|---|---|
| Group Schema Therapy for eating disorders (GST) | Experimental | Behavioral: GSTGST 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. |
| Cognitive Behavioral Therapy-Enhanced (CBT-E) (TAU) | Active comparator | Behavioral: CBT-EThis 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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSTOutpatient eating disorder treatment (5 individual pre-group sessions followed by 26 weekly group sessions + 8 optional individual sessions) | Behavioural | Group Schema Therapy for eating disorders (GST) |
| CBT-EOutpatient eating disorder treatment (20-40 weekly individual sessions) | Behavioural | Cognitive Behavioral Therapy-Enhanced (CBT-E) (TAU) |
Primary outcome
Change in Eating Disorder Examination Questionnaire (EDE-Q) score
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
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.
10 secondary outcomes
Childhood Trauma Questionnaire-Short Form (CTQ-SF)
Time frame: Baseline (Before start CBT-E)
Change in Young Schema Questionnaire Short Form version 3 3 (YSQ-S3) score
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
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
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
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)
Time frame: Baseline (Before start CBT-E)
Session Rating Scale (SRS)
Time frame: up to 39 weeks
Quality of life and achievement personalized treatment goals
Time frame: End of treatment (up to 39 weeks after randomization)
Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 38439092Mares SHW, Roelofs J, Zinzen J, Beatse M, Elgersma HJ, Drost RMWA, Evers SMAA, Elburg AAV. Clinical effectiveness, cost-effectiveness and process evaluation of group schema therapy for eating disorders: study protocol for a multicenter randomized controlled trial. BMC Psychol. 2024 Mar 4;12(1):123. doi: 10.1186/s40359-024-01624-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Roelofs principal investigator
Maastricht University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GST and CBT-E in people with Anorexia Nervosa and Atypical Anorexia Nervosa (Other Specified Eating Disorder), run by Maastricht University at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Roelofs, Dr. (+31433881607, j . roelofs @ maastricht university . nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eating Disorder Examination Questionnaire (EDE-Q) score (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05812950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.