A Study of Remission Criteria in Anorexia Nervosa: A Multidimensional Exploratory Observational Study of Recovery Among Patients in Remission According to the Bardone-Cone Criteria
NCT07924358, Not applicable, Not yet recruiting, Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of Remission Criteria in Anorexia Nervosa: A Multidimensional Exploratory Observational Study of Recovery Among Patients in Remission According to the Bardone-Cone Criteria | ClinicalTrials.gov |
| NCT number | NCT07924358 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie | ClinicalTrials.gov |
| Conditions | Anorexia Nervosa | ClinicalTrials.gov |
| Interventions | Scales and questionnaires | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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 | At the inclusion visit (single assessment) | 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. | ClinicalTrials.gov |
| Secondary | Mean score on the Generalized Anxiety Disorder-7 (GAD-7) scale (range 0-21) among patients in clinical remission from anorexia nervosa | At the inclusion visit (single assessment) | 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). | ClinicalTrials.gov |
| Secondary | Mean total score on the Eating Disorder Inventory-2 (EDI-2) among patients in clinical remission from anorexia nervosa | At the inclusion visit (single assessment) | 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). | ClinicalTrials.gov |
| Secondary | Mean score on the Eating Disorders Quality of Life (EDQOL) questionnaire among patients in clinical remission from anorexia nervosa | At the inclusion visit (single assessment) | 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). | ClinicalTrials.gov |
| Secondary | Mean score on the Patient Health Questionnaire-9 (PHQ-9) (range 0-27) among patients in clinical remission from anorexia nervosa | At the inclusion visit (single assessment) | 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). | ClinicalTrials.gov |
| Secondary | Mean score on the Work and Social Adjustment Scale (WSAS) (range 0-40) among patients in clinical remission from anorexia nervosa | At the inclusion visit (single assessment) | 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). | ClinicalTrials.gov |
| Secondary | Mean score on the Functioning Assessment Short Test (FAST) (range 0-72) among patients in clinical remission from anorexia nervosa | At the inclusion visit (single assessment) | 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). | ClinicalTrials.gov |
| Secondary | Mean score on the Female Sexual Function Index (FSFI) (range 2-36) among patients in clinical remission from anorexia nervosa | At the inclusion visit (single assessment) | 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). | ClinicalTrials.gov |
| Secondary | Percentage of participants with clinically significant depressive symptoms, defined as Patient Health Questionnaire-9 (PHQ-9) total score ≥10 | At the inclusion visit (single assessment) | 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 | ClinicalTrials.gov |
| Secondary | Percentage of participants with clinically significant anxiety symptoms, defined as Generalized Anxiety Disorder-7 (GAD-7) total score ≥10 | At the inclusion visit (single assessment) | 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. | ClinicalTrials.gov |
| Secondary | Percentage of participants with clinically significant daily functional impairment, defined as Work and Social Adjustment Scale (WSAS) total score >20 | At the inclusion visit (single assessment) | 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. | ClinicalTrials.gov |
| Secondary | Percentage of participants with clinically significant psychosocial functioning impairment, defined as Functioning Assessment Short Test (FAST) total score >11 | At the inclusion visit (single assessment) | 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. | ClinicalTrials.gov |
| Secondary | Percentage of participants with clinically significant sexual dysfunction, defined as Female Sexual Function Index (FSFI) total score ≤26.55 | At the inclusion visit (single assessment) | 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 | ClinicalTrials.gov |
| Secondary | Number and percentage of participants per response category on the closed items of the REMAN questionnaire assessing self-perceived remission from anorexia nervosa | At the inclusion visit (single assessment) | 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. | ClinicalTrials.gov |
| Secondary | Spearman correlation coefficient between the REMAN item on self-perceived remission (Likert scale) and the PHQ-9 total score (range 0-27) | At the inclusion visit (single assessment) | 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. | ClinicalTrials.gov |
| Secondary | 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) | At the inclusion visit (single assessment) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)