Clinical trial NCT04883554: Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study
Official title: Impact of an Olfactory Sensory Therapeutic Group in the Therapeutic Armamentarium for Adolescent Patients With Restrictive Anorexia Nervosa, Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: evolution of eating disorder
timeFrame: at 9 months after inclusion
Secondary outcomes:
measure: Evolution of the Body Mass Index (BMI)
timeFrame: at 3, 6, and 9 months after inclusion
measure: Clinical Global Impression (CGI) Severity scale
timeFrame: at 9 months after inclusion
measure: Clinical Global Impression (CGI) Improvement scale
timeFrame: at 9 months after inclusion
measure: Quality of life deterioration score (QUAVIAM)
timeFrame: at 9 months after inclusion
measure: Beck Depression Inventory (BDI)
timeFrame: at 9 months after inclusion
measure: Situational anxiety and anxiety trait inventory (STAI-Y)
timeFrame: at 9 months after inclusion
measure: Yale-Brown Obsession Compulsion Scale (Y-BOCS)
timeFrame: at 9 months after inclusion
measure: Child Post-Traumatic Stress-Reaction Index (CPTS-RI)
timeFrame: at 9 months after inclusion
measure: The Autistic Quotient (AQ)
timeFrame: at 9 months after inclusion
measure: Cognitive Remediation Therapy (CRT)
timeFrame: at 9 months after inclusion
measure: "Sensory Profile" self-quiz (Brown, Dunn).
timeFrame: at 9 months after inclusion
measure: Helping Alliance Questionnaire (HAQ)
timeFrame: at 9 months after inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
Study officials:
References: