Anorexia NervosaACAMTONCT04666415
Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa.
A study testing Osteopathic treatment in people with Anorexia Nervosa and Osteopathic Medicine, run by Institut Mutualiste Montsouris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 20 years, women only
- Conditions the study is for
- Anorexia Nervosa, Osteopathic Medicine
- What is being tested?
- Osteopathic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2020to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Isabelle SAURET contact
France1 site, 1 recruiting
- Recruiting
Institut Mutualiste Montsouris
Paris, 75014
Aurélie LETRANCHANT, M.D., +33145616933, Aurelie.Letranchant@imm.fr
Isabelle SAURET, +33156616705, Isabelle.Sauret@imm.fr
About this study
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
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.
Read more
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.
- Conditions
- Anorexia Nervosa, Osteopathic Medicine
- Being tested
- Osteopathic treatment
- Keywords
- Interoception, Randomized controlled trial, Body approach
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic treatment + as-usual treatment | Experimental | 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. Receives: Other: Osteopathic treatment |
| As-usual treatment | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the evolution of interoceptive sensitivity
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of interoceptive sensitivity
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
Measured: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
To evaluate the evolution of interoceptive sensitivity
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
Measured: Arm 1: 1 week after the 5th session of osteopathic treatment, Arm 2: 6 weeks after the first questionnaires
Secondary outcomes (36)
To evaluate the evolution of weight
Weight measured in kilograms
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of weight
Weight measured in kilograms
Measured: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
To evaluate the evolution of weight
Weight measured in kilograms
Measured: 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
Actual physical pain (yes/no), precision of the localisation and intensity by Visual Analog Score (from 0 to 10)
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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)
Measured: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
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)
Measured: 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
Any constipation (yes/no) and precision of number of bowel movements per week
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the presence of constipation
Any constipation (yes/no) and precision of number of bowel movements per week
Measured: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
To evaluate the presence of constipation
Any constipation (yes/no) and precision of number of bowel movements per week
Measured: 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 of patient's eating disorder symptoms
EDDS : Eating Disorder Diagnostic Scale. Self-reported questionnaire for diagnosis of eating disorders.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: 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
EDI-2: Eating Disorders Inventory. The EDI-2 total score ranges from 91 to 546. Higher score means a worse outcome.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: 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
BSQ: Body shape questionnaire. The BSQ score ranges from 34 to 204. Higher score means a worse outcome.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: 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
BVAQ-B: Bermond-Vorst Alexithymia Questionnaire Form B. The BVAQ-B score ranges from 20 to 100. Higher score means a worse outcome.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: 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
RSE: Rosenberg Self-esteem Scale. The RSE score ranges from 10 to 40. Higher score means a worse outcome.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: 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
STAI-Y: State-Trait Anxiety Inventory, Form Y. The STAI-Y score ranges from 20 to 80. Higher score mean a worse outcome.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
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.
Measured: 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
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.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: 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
HAD-depression: Hospital Anxiety and Depression scale-depression. The HAD-depession score ranges from 0 to 21. Higher score means a worse outcome.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: Arm 1: Before the 3rd session, Arm 2: 3 weeks after the first questionnaires
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.
Measured: 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
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
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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
Measured: 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
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.
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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.
Measured: 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
EDS-R: Exercise-Dependence Scale-Revised, The EDS-R score ranges from 21 to 126. Higher score means worse outcome
Measured: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
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
Measured: Arm 1: Before the 3rd session, Arm 2: 3 weeks after the first questionnaires
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
Measured: 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)
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
Measured: Arm 1: before each of the 5 osteopathic treatment sessions
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
Measured: Arm 1:1 week after the 5th session of osteopathic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start6 Feb 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Aurélie LETRANCHANT, M.D., Principal investigator, Institut Mutualiste MontsourisMaurice CORCOS, M.D., Ph.D., Study director, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666415
- Sponsor's protocol ID
- PSY IMM-N°010-2019
- Acronym
- ACAMTO
- Status last verified
- Dec 2020
- First submitted
- 28 Aug 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34819116
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04666415
- Acronym / sponsor ID
- ACAMTO / PSY IMM-N°010-2019
- Conditions
- Anorexia Nervosa, Osteopathic Medicine
- Keywords
- Interoception, Randomized controlled trial, Body approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic treatment + as-usual treatment | Experimental | Other: Osteopathic treatmentOsteopathic 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 | No intervention | –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. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic treatmentTargeted 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. | Other | Osteopathic treatment + as-usual treatment |
Primary outcome
To evaluate the evolution of interoceptive sensitivity
Time frame: 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
To evaluate the evolution of interoceptive sensitivity
Time frame: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version
To evaluate the evolution of interoceptive sensitivity
Time frame: 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
36 secondary outcomes
To evaluate the evolution of weight
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of weight
Time frame: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
To evaluate the evolution of weight
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the presence of any physical pain
Time frame: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
To evaluate the presence of any physical pain
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the presence of constipation
Time frame: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
To evaluate the presence of constipation
Time frame: 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 of patient's eating disorder symptoms
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of nature of patient's eating disorder symptoms
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of seriousness of patient's eating disorder symptoms
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of seriousness of concerns about body image
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of seriousness of alexithymia
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of seriousness of self-esteem
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of seriousness of anxiety
Time frame: Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires
To evaluate the evolution of seriousness of anxiety
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of seriousness of depressive experiences
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of seriousness of depression
Time frame: Arm 1: Before the 3rd session, Arm 2: 3 weeks after the first questionnaires
To evaluate the evolution of seriousness of depression
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of nature and seriousness of self-injury
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of quality of life
Time frame: 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
Time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion
To evaluate the evolution of seriousness of physical activity dependence
Time frame: Arm 1: Before the 3rd session, Arm 2: 3 weeks after the first questionnaires
To evaluate the evolution of seriousness of physical activity dependence
Time frame: 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)
Time frame: Arm 1: before each of the 5 osteopathic treatment sessions
To evaluate the evolution of somatic dysfonctions (for Arm 1)
Time frame: Arm 1:1 week after the 5th session of osteopathic treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 34819116Letranchant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle SAURET contact
Aurélie LETRANCHANT, M.D. principal investigator
Institut Mutualiste Montsouris
Maurice CORCOS, M.D., Ph.D. study director
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment in people with Anorexia Nervosa and Osteopathic Medicine, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélie LETRANCHANT, M.D. (+33156616933, aurelie.letranchant@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the evolution of interoceptive sensitivity (time frame: Arm 1: 3 weeks after inclusion ie 1 week before the first session, Arm 2: 3 weeks after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.