Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study

NCT04883554 | Unknown

• 1 other identifier: 21-HPNCL-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Anorexia nervosa is a severe eating disorder of multifactorial origin and for which there is, to date, no specific, standardized and protocolized management for anorexic patients or data on the superiority of anorexia. type of psychotherapy. The literature reports altered olfactory capacities in anorexia nervosa and the effectiveness of sensory-mediated therapies in several mental disorders. This prospective, single-center, randomized and controlled study proposes the evaluation of the therapeutic impact of an olfactory sensory group carried out during the specialized care of patients aged 12 to 20 years, with anorexia. The main objective is to compare the clinical course of eating disorder, using the Eating Attitudes Test-40 (EAT-40) scale score performed at study inclusion and at 9 months at 9 months, of patients participating in an olfactory sensory therapeutic group compared to a body approach therapeutic group. The secondary objectives of this study are to compare between a treatment associated with an olfactory sensory therapeutic group and a body approach therapeutic group, the evolution of the Body Mass Index at 9 months, overall functioning, evolution of cognitive and sensory capacities, and evolution of the therapeutic alliance at 9 months

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• evolution of eating disorder

  Clinical course of the eating disorder of anorexic patients scores of the Eating Attitudes Test-40 (EAT-40) scale. Self-diagnostic and quantitative questionnaire of 40 questions 6 response levels ranging from: not at all / never to extremely / always Items 1, 18, 19, 23, 27, 34, 39 are presented inverted. Whatever the direction of the presentation, each extreme response of the anorexic type corresponds to 3 points, the next to 2, the third to 1 and the three others to 0. The score varies from 0 to 120. The threshold score is 30, that is, any subject with a score ≥ 30 has an eating disorder Performed at inclusion of subjects in the study and at 9 months

  at 9 months after inclusion

Secondary Outcomes (12)

• Evolution of the Body Mass Index (BMI)

  at 3, 6, and 9 months after inclusion

• Clinical Global Impression (CGI) Severity scale

  at 9 months after inclusion

• Clinical Global Impression (CGI) Improvement scale

  at 9 months after inclusion

• Quality of life deterioration score (QUAVIAM)

  at 9 months after inclusion

• Beck Depression Inventory (BDI)

  at 9 months after inclusion

Study Arms (2)

Olfactory therapy group

EXPERIMENTAL

The therapeutic group takes place in specific stages on a weekly basis and lasts approximately 45 minutes. The group consists of a maximum of 6 patients of approximately the same age. The therapists leading the therapeutic group choose in advance the smells that will be offered to patients, based on one odor for each of the following categories: food and woody / flowery. The odors circulate between the participants of the group (patients and therapists), on wipes of blotting paper soaked in the bottles and soaked in the odors. The first step of the therapeutic group is "olfactory perception": this is the moment when the odors selected for the session are presented to the patients. Each scent goes around the patients and therapists, three times and without verbalization. Therefore, patients can express their feelings through drawing or writing on distributed sheets. . In a second step, called "rendering", patients are asked to express what they think of the smell presented.

Other: Olfactory therapeutic

Body therapy group

ACTIVE COMPARATOR

The therapeutic group takes place according to very specific stages at a weekly frequency and lasts 1 hour. The group is made up of a maximum of 6 patients. This workshop includes three times divided equally over a period of 1 hour: Kinesic time or time to set the body in motion (20 min): These techniques involve lying on the floor on a mat and approaching the movement slowly. The movements are suggested by the patients and then imitated by the rest of the group. Kinesthetic time: time of slow movements (20 min): During this time, the patient is asked to find a period of calm close to immobility without imposing the instruction. They are asked to touch the different parts of the body as slowly as possible in isolation, starting and ending in the center of the body. Talk time (20 min): Patients are invited to verbalize what they felt bodily

Other: Body therapy

Interventions

Olfactory therapeutic OTHER

The sessions of the olfactory sensory therapy group take place according to the care framework at a frequency of one session of 45 minutes per week

Olfactory therapy group

Body therapy OTHER

very specific stages at a weekly frequency and lasts 1 hour. Kinesic time or time to set the body in motion (20 min) Kinesthetic time: time of slow movements (20 min) Talk time (20 min)

Body therapy group

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged from 12 to 20 years old
• Diagnosed with restrictive anorexia nervosa, according to Diagnostic and Statistical Manual 5 (DSM 5) criteria and who have not yet entered the care pathway
• Affiliated with the social security scheme
• Good understanding of written and oral French
• Collection of informed consent from the adult subject
• Collection of informed consent from one of the two parents or holder of parental authority if the subject is a minor

You may not qualify if:

• All pathologies that may explain an olfactory sensory disorder: genetic, neurological, neurosensory or rhino laryngeal pathologies (chronic bronchitis, polyps, etc.)
• History of participation in an olfactory sensory therapy group
• The restriction disorder or avoidance of food intake (ARFID, Avoidant and Restrictive Food Intake Disorder)
• Active smoking
• Intellectual disability (ITQ \<70)
• Known allergy to essential or fragrant oils
• A urine pregnancy test will be performed for young women of childbearing age.
• Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment by virtue of ..
• Adults who are the subject of a legal protection measure or who are unable to express their consent.

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Mind-Body Therapies

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: September 28, 2021
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

FR (1)