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

NCT04666415 | Unknown

• 1 other identifier: PSY IMM-N°010-2019
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Osteopathic Medicine

Keywords

Interoception; Randomized controlled trial; Body approach

Outcome Measures

Primary Outcomes (3)

• To evaluate the evolution of interoceptive sensitivity

  fMAIA scale : Multidimensional Assessment of Interoceptive Awareness, French version

  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

  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

  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

  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

  Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 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 presence of any physical pain

  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

  Arm 1: Before the 3rd session of osteopathic treatment, Arm 2: 3 weeks after the first questionnaires

Study Arms (2)

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.

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.

Interventions

Osteopathic treatment OTHER

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.

Osteopathic treatment + as-usual treatment

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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"

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 34819116 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Aurélie LETRANCHANT, M.D.

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

• Maurice CORCOS, M.D., Ph.D.

  Institut Mutualiste Montsouris

  STUDY DIRECTOR

Central Study Contacts

Aurélie LETRANCHANT, M.D.

CONTACT

+33156616933; aurelie.letranchant@imm.fr

Isabelle SAURET

CONTACT

isabelle.sauret@imm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: December 14, 2020
• Study Start: February 6, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)