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

NCT ID: NCT04883554

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2024-09-30

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

Detailed Description

Currently, there is no specific consensus on the treatment of anorexia nervosa due to a lack of international scientific evidence. The guidelines recommend that patients be managed on an outpatient basis whenever possible with psychological treatment. This treatment must be provided by experience and a qualified service that can also assess the physical risks. Family therapy is the most popular psychological treatment for children and adolescents with anorexia nervosa. The drugs are considered adjunctive therapy and often have not shown significant results. Nutritional rehabilitation programs establish target weights based on body mass index (BMI). The target is calculated for the age percentiles. Weight restoration requires cognitive restructuring therapy to treat cognitive impairment associated with a state of calorie restriction. In the University Department of Child and Adolescent Psychiatry (UDCAP), we offer highly specialized treatment for restrictive anorexia in children and adolescents, which has been progressively developed over more than 25 years by a multidisciplinary team based on sensory-cognitive therapy is associated with this specific treatment. This treatment, based on sensori-cognitive therapy, is combined with the specific treatment recommended by theFrench National Authority for Health (HAS :Haute Autorité de Santé). The literature hypothesizes impaired sensory abilities are a central symptom of anorexia nervosa. Therefore, sensory impairment is expected to alter instinctive perceptions and gradually destroy recognition of primary needs. This theory of sensory integration is based on the principles of neuroscience, psychology and rehabilitation. Stimulation of olfactory sensory cognition has been used systematically in the first-line treatment of anorexic patients at UDCAP for many years and has shown encouraging clinical results which remain to be scientifically demonstrated. This study proposes the evaluation of the therapeutic impact of an olfactory sensory group carried out during the specialized care of patients with anorexia.

The main objective of this single-center, randomized, controlled, single-blind, prospective study is to compare the clinical course of eating disorder at 9 months of patients participating in an olfactory sensory therapeutic group compared to a body approach therapeutic group, classically recommended in conventional management, in patients aged 12 to 20 years with restrictive anorexia nervosa. The main objective is assessed using the Eating Attitudes Test-40 (EAT-40) scale score performed at study inclusion and at 9 months. 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 (BMI) at 9 months, Overall functioning, assessed using the Clinical Global Impression (CGI) at 9 months, Clinical evolution at 9 months assessed with clinical scales : Quality of life deterioration score (QUAVIAM), Beck Depression Inventory (BDI), Situational anxiety and anxiety trait inventory (STAI-Y), Yale-Brown Obsession Compulsion Scale (Y-BOCS), Child Post-Traumatic Stress-Reaction Index (CPTS-RI), The Autistic Quotient (AQ) ; Evolution of cognitive and sensory capacities at 9 months assessed with mental flexibility tests of Cognitive Remediation Therapy (CRT) and the self-questionnaire "Sensory profile" (Brown, Dunn)., Evolution of the therapeutic alliance at 9 months will be assessed with the Helping Alliance Questionnaire (HAQ).

The number of subjects required is 30 patients, 15 patients per group, with alpha risk of 5% and a power of 80%, with an estimated number of lost to follow-up of 30%.

The estimated duration of this study is 27 months, with a participation time for each patient of 9 months.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Olfactory therapy group

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.

Group Type: EXPERIMENTAL

Olfactory therapeutic

Intervention Type: 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

Body therapy group

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

Group Type: ACTIVE_COMPARATOR

Body therapy

Intervention Type: 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)

Interventions

Olfactory therapeutic

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

Intervention Type: OTHER

Body therapy

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Foreseeable inability to comply with the instructions defined and exposed upon inclusion

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Lenval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, , France

Countries

France

Other Identifiers

21-HPNCL-02

Identifier Type: -

Identifier Source: org_study_id