Anorexia Nervosa, Osteopathic Medicine
Conditions
Keywords
Interoception, Randomized controlled trial, Body approach
Brief summary
Abstract: Background: Anorexia nervosa (AN) is a common pathology affecting mainly women (sex ratio 1/10), which starts most often during adolescence. The prognosis of the AN remains poor (10% of deaths and high risk of chronicity). Body dissatisfaction, disturbances in recognition and identification of body sensations are some of the key symptoms of AN. There is, however, a contrast between this consensual observation of the importance of troubles in body image in AN, and the relative deficit of specifically targeted body treatments. Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture, breathing, muscle tension and body perception are closely linked to our psychological and emotional state, and are therefore disturbed in patients with AN. The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to as-usual care is significantly more effective compared to as-usual care. Methods: Seventy-two female patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups : one receiving the specific osteopathic treatment targeted for AN in addition to the as-usual care (group A) and the other one, the as-usual care (group B). The patients of group A will receive 5 sessions of osteopathic treatment for 25 minutes. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be realized. The as-usual care is defined by the multidisciplinary approach recommended by the high authority of health. The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms and assessment of somatic dysfonctions' evolution. A qualitative study will also be carried out, applying the Interpretative Phenomenological Analysis method. Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation. Discussion: If the results of the study are positive (statistically significant effectiveness of this body approach in addition to as-usual care compared to as-usual treatment), patients with anorexia will be benefit from the possibility of additional treatment that is effective, relatively inexpensive, non-invasive and non-pharmacological.
Interventions
Targeted osteopathic protocol for AN : 5 sessions of osteopathic treatment that are spaced around one week between 2 sessions. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be realized during the session of 25 minutes.
Sponsors
Fondation de l'Avenir
Institut Mutualiste Montsouris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessor of the clinical and psychological outcomes (research psychologist) will be blinded to the treatment group and will use standardized research questionnaires. Assessors of the osteopathic outcomes will not perform the osteopathic sessions, to guarantee an independent evaluation.
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* female * patient aged between 13 to 20 years included * patient has a Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) diagnosis of Nnorexia nervosa (restricting or binge-eating/purging types) * Body Mass Index (BMI) ≥ 14 kg.m-² * Followed up in consultation for at least 2 months or hospitalized in the psychiatry unit of Institut Mutualiste Montsouris * has a clinical/somatic state compatible with the conduct of osteopathic treatment sessions (prior medical advice) * is not in separation period (In the adolescent and young adult psychiatry department of Institut Mutualiste Montsouris, during a full-time hospitalization for AN, the separation period is linked to the establishment of a hospitalization contract between the medical team, the family and the patient. This contract will define a time of separation between the family and the patient. It is built around two axes: the final discharge weight allowing the patient to leave the service and the intermediate weight called separation lifting weight. This lifting weight of separation is thus named because it puts an end to the first part of hospitalization that takes place in separation from the living environment of the patient (parents, friends, schooling...) * signed the Informed Consent Form and both parents for minor patient, * is not included in another research protocol. Non-inclusion criteria: * male * patient under 13 years old or over 20 years old * has contraindication to osteopathic body approach sessions (fracture, recent surgery, etc.) * with a Body Mass Index (BMI) \< 14 kg.m-² * patient needs a naso-gastric tube * is in separation period * is not fluent in French * is not covered by health insurance * is included in another research protocol.
Exclusion criteria
* patient has contraindication to osteopathic body approach sessions (fracture, recent surgery, somatic state not compatible with the osteopathic treatment) * is not covered by health insurance * is included in another research protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the evolution of interoceptive sensitivity | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the presence of any physical pain | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | Actual physical pain (yes/no), precision of the localisation and intensity by Visual Analog Score (from 0 to 10) |
| To evaluate the presence of constipation | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | Any constipation (yes/no) and precision of number of bowel movements per week |
| To evaluate the evolution of nature of patient's eating disorder symptoms | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | EDDS : Eating Disorder Diagnostic Scale. Self-reported questionnaire for diagnosis of eating disorders. |
| To evaluate the evolution of seriousness of patient's eating disorder symptoms | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | EDI-2: Eating Disorders Inventory. The EDI-2 total score ranges from 91 to 546. Higher score means a worse outcome. |
| To evaluate the evolution of seriousness of concerns about body image | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | BSQ: Body shape questionnaire. The BSQ score ranges from 34 to 204. Higher score means a worse outcome. |
| To evaluate the evolution of seriousness of alexithymia | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | BVAQ-B: Bermond-Vorst Alexithymia Questionnaire Form B. The BVAQ-B score ranges from 20 to 100. Higher score means a worse outcome. |
| To evaluate the evolution of seriousness of self-esteem | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | RSE: Rosenberg Self-esteem Scale. The RSE score ranges from 10 to 40. Higher score means a worse outcome. |
| To evaluate the evolution of weight | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | Weight measured in kilograms |
| To evaluate the evolution of seriousness of depressive experiences | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | DEQ: Depressive Experiences Questionnaire - Adolescent Version. The Depressive Experiences Questionnaire (DEQ) is a 66 item questionnaire where participants rate themselves on life experiences and personality characteristics frequently associated with depression. Participants are asked to rate each item on a seven-point Likert-type scale ranging from strongly disagree (1) to strongly agree (7). Analysis of results produces 3 factors: Dependency, Self-criticism, and Efficacy. |
| To evaluate the evolution of seriousness of depression | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | HAD-depression: Hospital Anxiety and Depression scale-depression. The HAD-depession score ranges from 0 to 21. Higher score means a worse outcome. |
| To evaluate the evolution of nature and seriousness of self-injury | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | OSI: Ottawa Self-injury Questionnaire. OSI (Ottawa Self-Injury) to measure occurrence, frequency, level of motivation to stop, types and functions and potential addictive features of self-injury |
| To evaluate the evolution of quality of life | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | ED-QOL: Eating Disorders Quality of Life Scale. The EDQOL has 25 items that contribute to four subscales (Psychological, Physical/Cognitive, Work/School, and Financial), which combined produce an overall quality of life score. Each item is coded on a five-point scale and asks the participant to rate the extent to which they perceive their eating disorder to affect their quality of life in different domains. Higher scores indicate lower quality of life. |
| To evaluate the evolution of seriousness of physical activity dependence | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | EDS-R: Exercise-Dependence Scale-Revised, The EDS-R score ranges from 21 to 126. Higher score means worse outcome |
| To evaluate the evolution of somatic dysfonctions (for Arm 1) | Arm 1: before each of the 5 osteopathic treatment sessions | SOAP note form. This is a standardized tool to evaluate somatic dysfunctions (sensitivity, mobility, texture, asymmetry) and severity (from 0 to 3) for each body region |
| To evaluate the evolution of seriousness of anxiety | Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion | STAI-Y: State-Trait Anxiety Inventory, Form Y. The STAI-Y score ranges from 20 to 80. Higher score mean a worse outcome. |
Countries
France
Contacts
Primary ContactAurélie LETRANCHANT, M.D.
Backup ContactIsabelle SAURET
Outcome results
None listed