Monocentric Single-blind Randomized Controlled Trial Evaluating the Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- To evaluate the evolution of interoceptive sensitivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- 未提供
结局指标
主要结局
To evaluate the evolution of interoceptive sensitivity
时间窗: Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
次要结局
- To evaluate the evolution of nature of patient's eating disorder symptoms(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of seriousness of concerns about body image(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of seriousness of self-esteem(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of seriousness of depressive experiences(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the presence of any physical pain(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the presence of constipation(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of seriousness of patient's eating disorder symptoms(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of seriousness of alexithymia(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of seriousness of anxiety(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of seriousness of depression(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of nature and seriousness of self-injury(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of weight(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of seriousness of physical activity dependence(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of quality of life(Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires)
- To evaluate the evolution of somatic dysfonctions (for Arm 1)(Arm 1:1 week after the 5th session of osteopathic treatment)