An interventional study of Scales and questionnaires in Anorexia Nervosa, sponsored by Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie · Not applicable, Interventional, and Other
Anorexia nervosa is a severe psychiatric disorder associated with substantial morbidity, persistent impairment in psychosocial functioning and quality of life, as well as a high risk of relapse. Although remission is now a major goal of treatment, its definition remains heterogeneous in the literature. The criteria proposed by Bardone-Cone and colleagues are currently the most widely used reference for defining clinical remission in anorexia nervosa. They are mainly based on weight, behavioural, and psychopathological criteria.
However, these criteria do not take into account important dimensions of recovery, such as psychosocial functioning, quality of life, anxiety or depressive symptoms, sexual health, or individuals' subjective perception of their health status.
This study therefore aims to explore the characteristics of patients considered to be in remission according to the criteria proposed by Bardone-Cone et al. and to describe any discrepancies between this remission status and different clinical, functional, and subjective dimensions of recovery.
The investigators hypothesise that patients meeting the remission criteria proposed by Bardone-Cone et al. may nevertheless experience persistent difficulties across different dimensions of recovery, such as quality of life, psychosocial functioning, residual symptoms, anxiety or depressive symptoms, sexual health, or their subjective perception of their progress. Thus, these remission criteria may not necessarily reflect all clinically relevant dimensions of recovery.
This study proposes a multidimensional approach to remission in anorexia nervosa by examining the Bardone-Cone criteria in relation to the different recognised dimensions of recovery: specific residual symptoms, quality of life, psychosocial functioning, functional impairment, anxiety and depressive symptoms, sexual health, and subjective perception of remission.
Unlike studies aiming to propose a new definition of remission, this study seeks to assess the extent to which the criteria currently used can identify patients experiencing satisfactory recovery across these different dimensions. The results may contribute to a better characterisation of the potential limitations of the criteria currently used and inform future research on the assessment of remission in eating disorders.
Anorexia nervosa is a severe eating disorder (ED) that may have a lasting impact on quality of life and psychosocial functioning. Its course, which is often prolonged, may be characterised by periods of improvement, relapses, or the persistence of clinical impairments.
The course of anorexia nervosa remains heterogeneous: some patients experience sustained remission, whereas others experience repeated relapses or a chronic course. This diversity of trajectories has been documented by long-term follow-up studies and by studies investigating relapse and the longitudinal validity of recovery criteria. This explains why the definition of remission represents a major issue for both clinical practice and research.
Methods for assessing recovery remain variable across studies, particularly with regard to the consideration of functional and subjective dimensions. Studies rely on different combinations of criteria, which limits their comparability, makes it difficult to interpret remission and relapse rates reported in the literature, and complicates the identification of a common approach to recovery.
In this context, the multidimensional operationalisation proposed by Bardone-Cone et al., initially validated in 2010 and subsequently evaluated longitudinally in 2019, represents an important step towards standardising the assessment of recovery. Work published in 2025 further supports its relevance by comparing several operational definitions of remission .
This study therefore aims to explore the characteristics of patients considered to be in remission according to the criteria proposed by Bardone-Cone et al. and to describe any discrepancies between this remission status and different clinical, functional, and subjective dimensions of recovery. It does not aim to propose a new definition of remission, but rather to contribute to a better understanding of the dimensions associated with recovery in anorexia nervosa.
The results will help to better characterise the profiles of patients in remission and generate hypotheses for future studies aiming to further investigate the assessment of recovery in anorexia nervosa.
1.1. Current state of knowledge
1.1.1. The disease
According to the DSM-5, anorexia nervosa is an eating disorder characterised by persistent restriction of energy intake leading to a significantly low body weight relative to age, sex, and physical health. It is accompanied by an intense fear of gaining weight or becoming fat, which persists despite significantly low body weight, as well as by a disturbance in the way in which one's body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight.
The lifetime prevalence of anorexia nervosa is estimated at between 0.8 and 3.6% in women and around 0.1% in men, according to DSM-5 data. The disorder most commonly begins during adolescence or young adulthood. In the general population, the mean duration of anorexia nervosa is between 1.7 and 3 years, although the course may be shorter or chronic in a substantial proportion of patients.
Anorexia nervosa is associated with one of the highest mortality rates among psychiatric disorders, notably due to severe physical complications but also because of an increased risk of suicide. It is associated with substantial excess mortality compared with the general population of the same age, estimated to be approximately 5.2 times that observed in this population .
Furthermore, anorexia nervosa is frequently associated with psychiatric comorbidities. A nationally representative study showed that 87.3% of adults with anorexia nervosa met the criteria for at least one other psychiatric disorder, compared with 57.6% of individuals without an eating disorder.
Despite advances in the understanding and management of anorexia nervosa, its course remains heterogeneous. The meta-analysis by Steinhausen reported approximately 47% recovery, 33% improvement, and 20% chronic course at the end of follow-up.
In this context, the concept of remission plays a central role in the assessment of clinical trajectories. However, the absence of a consensual definition complicates the comparison of studies and contributes to the variability in relapse rates reported after treatment.
1.1.2. Standard and investigational treatments/strategies/procedures
The management of anorexia nervosa is based on a comprehensive and multidisciplinary approach involving psychiatric, nutritional, and psychotherapeutic care, taking into account the severity of the disorder, its duration, and associated psychiatric and non-psychiatric comorbidities.
Standard therapeutic strategies primarily aim to restore body weight and prevent physical complications, while simultaneously addressing the psychopathological dimensions of the disorder. Nutritional management plays a central role and aims to progressively normalise food intake and reduce restrictive and controlling behaviours. The initial objective of psychotherapeutic management is to promote engagement in care and the therapeutic alliance. In adults, randomised controlled trials have shown that several individual approaches may be effective, with none clearly emerging as superior, while treatment suitability and the quality of the therapeutic relationship remain key factors. Techniques used include cognitive behavioural therapy, interpersonal therapy, and psychodynamic approaches.
To date, no pharmacological treatment has demonstrated specific efficacy on the symptoms of anorexia nervosa. Pharmacological treatments are mainly used to manage psychiatric comorbidities, such as anxiety or depressive disorders.
Several studies have highlighted the impact of the choice of remission criteria on the assessment of clinical trajectories and treatment outcomes in anorexia nervosa. These findings emphasise the heterogeneous nature of the concept of remission and the major influence of the criteria used on the interpretation of clinical and research data.
In order to improve the standardisation of remission in eating disorders, Bardone-Cone et al. proposed a multidimensional operational definition of recovery in 2010. This definition combines three components: weight restoration, the absence of pathological eating behaviours, and normalisation of eating disorder psychopathology. Its concurrent and predictive validity was subsequently investigated longitudinally in 2019, and its relevance was reassessed in 2025 through a comparison of several operational definitions of remission.
This operationalisation currently represents one of the most structured and most frequently used definitions in research on recovery from eating disorders. It facilitates the harmonisation of criteria and the comparability of studies. However, it does not constitute a consensual or comprehensive definition of recovery.
Several limitations can indeed be identified. First, these criteria do not directly assess certain symptoms that may persist after weight and behavioural normalisation, such as anxiety or certain cognitive difficulties. Second, they do not explicitly incorporate the functional, social, or relational impact of the illness, nor psychiatric comorbidities. Third, they do not take into account the patient's subjective perception of recovery, although this plays an important role in contemporary conceptualisations of recovery.
Subjective experience has also been less extensively explored in studies of remission from eating disorders than clinical criteria defined by healthcare professionals. Nevertheless, contemporary models of recovery emphasise the value of incorporating the individual's subjective experience into the assessment of their progress.
It therefore appears essential to us to incorporate patients' perspectives into the consideration of remission, in order to better understand how they perceive their progress and recovery. Taking subjective experience into account may help to better mobilise patients' motivational factors, strengthen the therapeutic alliance, and promote adherence to the proposed treatments.
In this context, it appears relevant to examine the extent to which remission status defined according to the criteria proposed by Bardone-Cone et al., currently considered a reference definition, at least in a research context, is associated with the different dimensions of recovery, particularly clinical, functional, and subjective dimensions.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 40 is below the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
These instruments include self-report questionnaires completed by the patient and investigator-administered questionnaires.
Other: Scales and questionnaires
These instruments include self-report questionnaires completed by the patient and investigator-administered questionnaires.
Percentage of participants in clinical remission (Bardone-Cone criteria) with at least one clinically significant impairment on GAD-7, PHQ-9, WSAS, FAST or FSFIl
Number of participants in clinical remission (Bardone-Cone criteria) exceeding the threshold on at least one of 5 scales, divided by the number of participants in remission. Thresholds: GAD-7 total score ≥10 (range 0-21); PHQ-9 total score ≥10 (range 0-27); WSAS total score \>20 (range 0-40); FAST total score \>11 (range 0-72); FSFI total score ≤26.55 (range 2-36). Higher GAD-7, PHQ-9, WSAS and FAST scores and lower FSFI scores indicate worse outcomes.
Time frame: At the inclusion visit (single assessment)
Mean score on the Generalized Anxiety Disorder-7 (GAD-7) scale (range 0-21) among patients in clinical remission from anorexia nervosa
GAD-7 total score (sum of 7 items scored 0-3; higher scores indicate more severe anxiety symptoms), summarized as mean and standard deviation (or median and interquartile range if non-normally distributed).
Time frame: At the inclusion visit (single assessment)
Mean total score on the Eating Disorder Inventory-2 (EDI-2) among patients in clinical remission from anorexia nervosa
EDI-2 score (91 items rated on a 6-point scale, depending on the scoring method used; higher scores indicate more severe eating disorder symptoms), summarized as mean and standard deviation (or median and interquartile range if non-normally distributed).
Time frame: At the inclusion visit (single assessment)
Mean score on the Eating Disorders Quality of Life (EDQOL) questionnaire among patients in clinical remission from anorexia nervosa
EDQOL overall score (25 items rated on a 5-point scale, range 0-4; higher scores indicate greater impairment of quality of life), summarized as mean and standard deviation (or median and interquartile range if non-normally distributed).
Time frame: At the inclusion visit (single assessment)
Mean score on the Patient Health Questionnaire-9 (PHQ-9) (range 0-27) among patients in clinical remission from anorexia nervosa
PHQ-9 total score (sum of 9 items scored 0-3; higher scores indicate more severe depressive symptoms), summarized as mean and standard deviation (or median and interquartile range if non-normally distributed).
Time frame: At the inclusion visit (single assessment)
Mean score on the Work and Social Adjustment Scale (WSAS) (range 0-40) among patients in clinical remission from anorexia nervosa
WSAS total score (sum of 5 items scored 0-8; higher scores indicate greater functional impairment in daily life), summarized as mean and standard deviation (or median and interquartile range if non-normally distributed).
Time frame: At the inclusion visit (single assessment)
Mean score on the Functioning Assessment Short Test (FAST) (range 0-72) among patients in clinical remission from anorexia nervosa
FAST total score (sum of 24 items scored 0-3; higher scores indicate greater psychosocial functioning impairment), summarized as mean and standard deviation (or median and interquartile range if non-normally distributed).
Time frame: At the inclusion visit (single assessment)
Mean score on the Female Sexual Function Index (FSFI) (range 2-36) among patients in clinical remission from anorexia nervosa
FSFI total score (19 items; higher scores indicate better sexual function), summarized as mean and standard deviation (or median and interquartile range if non-normally distributed).
Time frame: At the inclusion visit (single assessment)
Percentage of participants with clinically significant depressive symptoms, defined as Patient Health Questionnaire-9 (PHQ-9) total score ≥10
Number of participants in clinical remission with a PHQ-9 total score ≥10 (range 0-27; higher scores indicate more severe depressive symptoms), divided by the total number of participants in remission
Time frame: At the inclusion visit (single assessment)
Percentage of participants with clinically significant anxiety symptoms, defined as Generalized Anxiety Disorder-7 (GAD-7) total score ≥10
Number of participants in clinical remission with a GAD-7 total score ≥10 (range 0-21; higher scores indicate more severe anxiety symptoms), divided by the total number of participants in remission.
Time frame: At the inclusion visit (single assessment)
Percentage of participants with clinically significant daily functional impairment, defined as Work and Social Adjustment Scale (WSAS) total score >20
Number of participants in clinical remission with a WSAS total score \>20 (range 0-40; higher scores indicate greater functional impairment), divided by the total number of participants in remission.
Time frame: At the inclusion visit (single assessment)
Percentage of participants with clinically significant psychosocial functioning impairment, defined as Functioning Assessment Short Test (FAST) total score >11
Number of participants in clinical remission with a FAST total score \>11 (range 0-72; higher scores indicate greater psychosocial functioning impairment), divided by the total number of participants in remission.
Time frame: At the inclusion visit (single assessment)
Percentage of participants with clinically significant sexual dysfunction, defined as Female Sexual Function Index (FSFI) total score ≤26.55
Number of participants in clinical remission with an FSFI total score ≤26.55 (range 2-36; lower scores indicate worse sexual function), divided by the number of participants in remission
Time frame: At the inclusion visit (single assessment)
Number and percentage of participants per response category on the closed items of the REMAN questionnaire assessing self-perceived remission from anorexia nervosa
Responses to the closed items of the exploratory, non-validated ad hoc REMission in ANorexia nervosa (REMAN) questionnaire, covering: (1) self-perception of being in remission, (2) personal definition and representation of remission, (3) dimensions associated with the feeling of remission (symptomatic, functional, psychological, relational, identity-related), (4) temporality of the remission process, (5) element perceived as contributing most to the feeling of remission. Items are mostly Likert scales and are treated as ordinal variables. For each item, results are reported as number and percentage of participants per response category, with median and interquartile range for Likert items. No total score is computed. Free-text comments are not formally analysed.
Time frame: At the inclusion visit (single assessment)
Spearman correlation coefficient between the REMAN item on self-perceived remission (Likert scale) and the PHQ-9 total score (range 0-27)
Spearman rank correlation coefficients (rho, range -1 to +1) between each Likert item of the exploratory, non-validated REMAN questionnaire (ordinal variables, no total score) and the total scores on: EDI-2 (eating disorder symptoms), EDQOL (quality of life), FAST (psychosocial functioning, range 0-72), GAD-7 (anxiety, range 0-21), PHQ-9 (depression, range 0-27), WSAS (daily functioning, range 0-40) and FSFI (sexual function, range 2-36). Coefficients are reported with their 95% confidence intervals.
Time frame: At the inclusion visit (single assessment)
Median score on the EDI-2, EDQOL, FAST, GAD-7, PHQ-9, WSAS and FSFI scales in participants who consider themselves in remission versus those who do not (REMAN questionnaire)
Median and interquartile range (points on each scale) of the EDI-2, EDQOL, FAST (range 0-72), GAD-7 (range 0-21), PHQ-9 (range 0-27), WSAS (range 0-40) and FSFI (range 2-36) total scores, calculated separately in participants answering yes and no to the REMAN item on self-perceived remission, and compared between the two groups using the Mann-Whitney test.
Time frame: At the inclusion visit (single assessment)
No study locations are listed for this record.
Plan to share: No
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Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
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 12 months is below that.
Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie