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Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa. (ACAMTO)

Primary Purpose

Anorexia Nervosa, Osteopathic Medicine

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathic treatment
Sponsored by
Institut Mutualiste Montsouris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Interoception, Randomized controlled trial, Body approach

Eligibility Criteria

13 Years - 20 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Mutualiste MontsourisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Osteopathic treatment + as-usual treatment

As-usual treatment

Arm Description

Osteopathic treatment: a protocol of 5 sessions of osteopathic treatment that have a 25 minutes duration and are spaced of around one week between two sessions. As-usual treatment: The outpatient and inpatient treatment of the patients will be done in compliance with the Health Authorities' recommendations (HAS 2010). Multi-disciplinary care is proposed, possibly involving nurses, psychologists, psychiatrists, general practitioners, gynecologists, rheumatologists, dieticians, occupational therapists, body approach specialists and social workers.

As-usual treatment: The outpatient and inpatient treatment of the patients will be done in compliance with the Health Authorities' recommendations (HAS 2010). Multi-disciplinary care is proposed, possibly involving nurses, psychologists, psychiatrists, general practitioners, gynecologists, rheumatologists, dieticians, occupational therapists, body approach specialists and social workers.

Outcomes

Primary Outcome Measures

To evaluate the evolution of interoceptive sensitivity
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
To evaluate the evolution of interoceptive sensitivity
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
To evaluate the evolution of interoceptive sensitivity
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version

Secondary Outcome Measures

To evaluate the evolution of weight
Weight measured in kilograms
To evaluate the evolution of weight
Weight measured in kilograms
To evaluate the evolution of weight
Weight measured in kilograms
To evaluate the presence of any physical pain
Actual physical pain (yes/no), precision of the localisation and intensity by Visual Analog Score (from 0 to 10)
To evaluate the presence of any physical pain
Actual physical pain (yes/no), precision of the localisation and intensity by Visual Analog Score (from 0 to 10)
To evaluate the presence of any physical pain
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
Any constipation (yes/no) and precision of number of bowel movements per week
To evaluate the presence of constipation
Any constipation (yes/no) and precision of number of bowel movements per week
To evaluate the presence of constipation
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
EDDS : Eating Disorder Diagnostic Scale. Self-reported questionnaire for diagnosis of eating disorders.
To evaluate the evolution of nature of patient's eating disorder symptoms
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
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 patient's eating disorder symptoms
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
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 concerns about body image
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
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 alexithymia
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
RSE: Rosenberg Self-esteem Scale. The RSE score ranges from 10 to 40. Higher score means a worse outcome.
To evaluate the evolution of seriousness of self-esteem
RSE: Rosenberg Self-esteem Scale. The RSE score ranges from 10 to 40. Higher score means a worse outcome.
To evaluate the evolution of seriousness of anxiety
STAI-Y: State-Trait Anxiety Inventory, Form Y. The STAI-Y score ranges from 20 to 80. Higher score mean a worse outcome.
To evaluate the evolution of seriousness of anxiety
STAI-Y: State-Trait Anxiety Inventory, Form Y. The STAI-Y score ranges from 20 to 80. Higher score mean a worse outcome.
To evaluate the evolution of seriousness of anxiety
STAI-Y: State-Trait Anxiety Inventory, Form Y. The STAI-Y score ranges from 20 to 80. Higher score means a worse outcome.
To evaluate the evolution of seriousness of depressive experiences
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 depressive experiences
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
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 seriousness of depression
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 seriousness of depression
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
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 nature and seriousness of self-injury
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
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 quality of life
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
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 seriousness of physical activity dependence
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 seriousness of physical activity dependence
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)
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 somatic dysfonctions (for Arm 1)
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

Full Information

First Posted
August 28, 2020
Last Updated
December 11, 2020
Sponsor
Institut Mutualiste Montsouris
Collaborators
Fondation de l'Avenir
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1. Study Identification

Unique Protocol Identification Number
NCT04666415
Brief Title
Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa.
Acronym
ACAMTO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Mutualiste Montsouris
Collaborators
Fondation de l'Avenir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Osteopathic Medicine
Keywords
Interoception, Randomized controlled trial, Body approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic treatment + as-usual treatment
Arm Type
Experimental
Arm Description
Osteopathic treatment: a protocol of 5 sessions of osteopathic treatment that have a 25 minutes duration and are spaced of around one week between two sessions. As-usual treatment: The outpatient and inpatient treatment of the patients will be done in compliance with the Health Authorities' recommendations (HAS 2010). Multi-disciplinary care is proposed, possibly involving nurses, psychologists, psychiatrists, general practitioners, gynecologists, rheumatologists, dieticians, occupational therapists, body approach specialists and social workers.
Arm Title
As-usual treatment
Arm Type
No Intervention
Arm Description
As-usual treatment: The outpatient and inpatient treatment of the patients will be done in compliance with the Health Authorities' recommendations (HAS 2010). Multi-disciplinary care is proposed, possibly involving nurses, psychologists, psychiatrists, general practitioners, gynecologists, rheumatologists, dieticians, occupational therapists, body approach specialists and social workers.
Intervention Type
Other
Intervention Name(s)
Osteopathic treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the evolution of interoceptive sensitivity
Description
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of interoceptive sensitivity
Description
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
Time Frame
Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
Title
To evaluate the evolution of interoceptive sensitivity
Description
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Secondary Outcome Measure Information:
Title
To evaluate the evolution of weight
Description
Weight measured in kilograms
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of weight
Description
Weight measured in kilograms
Time Frame
Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
Title
To evaluate the evolution of weight
Description
Weight measured in kilograms
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the presence of any physical pain
Description
Actual physical pain (yes/no), precision of the localisation and intensity by Visual Analog Score (from 0 to 10)
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the presence of any physical pain
Description
Actual physical pain (yes/no), precision of the localisation and intensity by Visual Analog Score (from 0 to 10)
Time Frame
Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
Title
To evaluate the presence of any physical pain
Description
Actual physical pain (yes/no), precision of the localisation and intensity by Visual Analog Score (from 0 to 10)
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the presence of constipation
Description
Any constipation (yes/no) and precision of number of bowel movements per week
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the presence of constipation
Description
Any constipation (yes/no) and precision of number of bowel movements per week
Time Frame
Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
Title
To evaluate the presence of constipation
Description
Any constipation (yes/no) and precision of number of bowel movements per week
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of nature of patient's eating disorder symptoms
Description
EDDS : Eating Disorder Diagnostic Scale. Self-reported questionnaire for diagnosis of eating disorders.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of nature of patient's eating disorder symptoms
Description
EDDS : Eating Disorder Diagnostic Scale. Self-reported questionnaire for diagnosis of eating disorders.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of patient's eating disorder symptoms
Description
EDI-2: Eating Disorders Inventory. The EDI-2 total score ranges from 91 to 546. Higher score means a worse outcome.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of seriousness of patient's eating disorder symptoms
Description
EDI-2: Eating Disorders Inventory. The EDI-2 total score ranges from 91 to 546. Higher score means a worse outcome.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of concerns about body image
Description
BSQ: Body shape questionnaire. The BSQ score ranges from 34 to 204. Higher score means a worse outcome.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of seriousness of concerns about body image
Description
BSQ: Body shape questionnaire. The BSQ score ranges from 34 to 204. Higher score means a worse outcome.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of alexithymia
Description
BVAQ-B: Bermond-Vorst Alexithymia Questionnaire Form B. The BVAQ-B score ranges from 20 to 100. Higher score means a worse outcome.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of seriousness of alexithymia
Description
BVAQ-B: Bermond-Vorst Alexithymia Questionnaire Form B. The BVAQ-B score ranges from 20 to 100. Higher score means a worse outcome.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of self-esteem
Description
RSE: Rosenberg Self-esteem Scale. The RSE score ranges from 10 to 40. Higher score means a worse outcome.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of seriousness of self-esteem
Description
RSE: Rosenberg Self-esteem Scale. The RSE score ranges from 10 to 40. Higher score means a worse outcome.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of anxiety
Description
STAI-Y: State-Trait Anxiety Inventory, Form Y. The STAI-Y score ranges from 20 to 80. Higher score mean a worse outcome.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of seriousness of anxiety
Description
STAI-Y: State-Trait Anxiety Inventory, Form Y. The STAI-Y score ranges from 20 to 80. Higher score mean a worse outcome.
Time Frame
Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of anxiety
Description
STAI-Y: State-Trait Anxiety Inventory, Form Y. The STAI-Y score ranges from 20 to 80. Higher score means a worse outcome.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of depressive experiences
Description
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.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of seriousness of depressive experiences
Description
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.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of depression
Description
HAD-depression: Hospital Anxiety and Depression scale-depression. The HAD-depession score ranges from 0 to 21. Higher score means a worse outcome.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of seriousness of depression
Description
HAD-depression: Hospital Anxiety and Depression scale-depression. The HAD-depession score ranges from 0 to 21. Higher score means a worse outcome.
Time Frame
Arm 1: Before the 3rd session, Arm 2: 3 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of depression
Description
HAD-depression: Hospital Anxiety and Depression scale-depression. The HAD-depession score ranges from 0 to 21. Higher score means a worse outcome.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of nature and seriousness of self-injury
Description
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
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of nature and seriousness of self-injury
Description
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
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of quality of life
Description
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.
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of quality of life
Description
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.
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of physical activity dependence
Description
EDS-R: Exercise-Dependence Scale-Revised, The EDS-R score ranges from 21 to 126. Higher score means worse outcome
Time Frame
Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
Title
To evaluate the evolution of seriousness of physical activity dependence
Description
EDS-R: Exercise-Dependence Scale-Revised, The EDS-R score ranges from 21 to 126. Higher score means worse outcome
Time Frame
Arm 1: Before the 3rd session, Arm 2: 3 weeks after the first questionnaires
Title
To evaluate the evolution of seriousness of physical activity dependence
Description
EDS-R: Exercise-Dependence Scale-Revised, The EDS-R score ranges from 21 to 126. Higher score means worse outcome
Time Frame
Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Title
To evaluate the evolution of somatic dysfonctions (for Arm 1)
Description
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
Time Frame
Arm 1: before each of the 5 osteopathic treatment sessions
Title
To evaluate the evolution of somatic dysfonctions (for Arm 1)
Description
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
Time Frame
Arm 1:1 week after the 5th session of osteopathic treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie LETRANCHANT, M.D.
Phone
+33156616933
Email
aurelie.letranchant@imm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle SAURET
Email
isabelle.sauret@imm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie LETRANCHANT, M.D.
Organizational Affiliation
Institut Mutualiste Montsouris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maurice CORCOS, M.D., Ph.D.
Organizational Affiliation
Institut Mutualiste Montsouris
Official's Role
Study Director
Facility Information:
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie LETRANCHANT, M.D.
Phone
+33145616933
Email
Aurelie.Letranchant@imm.fr
First Name & Middle Initial & Last Name & Degree
Isabelle SAURET
Phone
+33156616705
Email
Isabelle.Sauret@imm.fr
First Name & Middle Initial & Last Name & Degree
Aurélie LETRANCHANT, M.D.
First Name & Middle Initial & Last Name & Degree
Maurice CORCOS, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Kim DE MONTEBELLO, Osteopath
First Name & Middle Initial & Last Name & Degree
Corinne DUGRE-LE BIGRE, psychologist
First Name & Middle Initial & Last Name & Degree
Isabelle NICOLAS, M.D.
First Name & Middle Initial & Last Name & Degree
Pablo VOTADORO, M.D.
First Name & Middle Initial & Last Name & Degree
Nina KALINDJIAN, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34819116
Citation
Letranchant A, Montebello YK, Bigre CD, Wagner A, Curt F, Silva J, Nicolas I, Votadoro P, Kalindjian N, Korchonnoff A, Gutierre A, Novelli AB, Pham-Scottez A, Corcos M. The ACAMTO study-impact of add-on osteopathic treatment on adolescent patients with anorexia nervosa: study protocol for a randomized controlled trial. Trials. 2021 Nov 24;22(1):839. doi: 10.1186/s13063-021-05810-8.
Results Reference
derived

Learn more about this trial

Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa.

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