Evaluation of Art-therapy on Alexithymia in Patients Suffering From Anorexia Nervosa and From Bulimia (ALEXART)

August 13, 2018 updated by: University Hospital, Toulouse

Evaluation of Art-therapy on Alexithymia in Patients Suffering From Anorexia Nervosa and From Bulimia,a Pilot Study

Alexithymia is often found in patients suffering from anorexia nervosa or from bulimia. Art-therapy is widely used in this indication without there is a study in the literature assessing it. ALEXART is an observational prospective multicenter cohort pilot study, assessing the effect at 3 months of art therapy on alexithymia, in patients presenting anorexia nervosa or bulimia.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Alexithymia, defined by difficulties to identify and describe feelings as well as a poverty of imaginary life, is found in patients with anorexia nervosa (AN) or bulimia (BN) in numerous studies. Some publications show that it is a factor of resistance in several forms of psychotherapies and of poor prognosis for these patients who already present a high rate of chronification and mortality because of the complications of the undernutrition and the suicide risk. Art therapy is very wide-spread in the care of AN and of BN, but little studied. About alexithymia, if there is no psychotherapy having made the proof of its efficiency currently, some studies suggest the interest of art-therapy on alexithymic features, but none, to our knowledge, estimated the effect.

The investigator suggest to describe the evolution at 3 months of art therapy on alexithymia, using the Toronto Alexithymia Scale in 20 items (TAS-20), in patients with AN or BN. The investigators shall also describe the evolution at 3 months with the TAS-20 as well as the relationship between variations of alexithymia and BMI in patients presenting AN at 1 and 3 months globally and in each of the centers. The investigators will also evaluate the effect of depression and anxiety at 1 and 3 months of art therapy on alexithymia.The investigators shall realize an observational prospective multicenter cohort study design. Each patient will receive standard care: multidisciplinary and corresponding to the HAS recommendations and semimonthly or weeklies sessions of art therapy, using all types of art. Thus, each patient will be her own control before art therapy.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France, 31059
        • University Hospital toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients with anorexia nervosa or bulimia nervosa in many studies and with alexithymia wich is a characteristic found in this patient.

Description

Inclusion Criteria:

  • to be a woman, aged 16 or more, having DSM-5 diagnosis of anorexia nervosa or bulimia nervosa, inpatient in "Psychiatry, Psychotherapy and Art Therapy" ward at CHU de Toulouse or at " clinique Castelviel " in Toulouse.

Exclusion Criteria:

  • acute psychotic symptoms
  • pregnant women
  • breast-feeding women
  • people under justice protection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient suffering from anorexia/bulimia
Each patient will receive standard care: multidisciplinary and corresponding to the HAS recommendations for anorexia nervosa and bulimia nervosa associated with semimonthly or weeklies sessions of art therapy treatment, using all types of art, realized by trained professional, in Toulouse. Each patient will be her own control before art therapy Female patients with anorexia nervosa or bulimia according to DSM-5 criteria, patient will be above 16 years-old

The main objective is to describe the evolution at 3 months on the alexithymic dimension in the course of a treatment in art therapy, in patients with anorexia nervosa or bulimia.

Art therapy is a generic term grouping different artistic disciplines adapted and used for therapeutic purposes. It is through commitment to creative work that the therapeutic work of elaboration and reflection takes place in contrast to verbal psychotherapies and mediated psychotherapies that use speech as the main therapeutic tool. All forms of practice referring to categories of art can be used: painting, music, modeling, dance, theater and writing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alexithymia rate using de Toronto Alexithymia Scale
Time Frame: 3 months
Alexithymia rate using de Toronto Alexithymia Scale (TSA) in 20 items at 3 months. TAS-20 is a self-questionnaire of 20 items rated from 1 (complete disagreement) to 5 (full agreement) evaluating three central dimensions of alexithymia: the difficulty of identifying Difficulties Identifying Feelings (DIF), Difficulties Describing Feelings (DDF), and Externally Oriented, Concrete Thinking (EOT).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI) evolution for anorexic patient
Time Frame: 3 months
Body Mass Index (BMI) evolution for anorexic patient at 3 months The lower the Body Mass Index (BMI), the more alexithymia is important. The weight is collected weekly (twice a week at the CHU) the same day in a standardized way: in the presence of a nurse, in the morning on an empty stomach, after going to the bathroom, underwear, and using the same scale . The size is measured in similar conditions with the same meter at the entrance. The BMI is calculated by performing the operation weight divided by height squared and is expressed in kg / m2.
3 months
Effect of depression on alexithymia using the Beck Depression Inventory-II
Time Frame: 3 month

Effect of depression on alexithymia at 3 month, using the Beck Depression Inventory-II (BDI-II) The revised version of the BDI or BDI-II, is a 21-item Likert scale-type self-questionnaire assessing depressive symptoms. These different items are rated from "rarely" (0) to often (3). The total score can be used to rate the severity of depression: 0 to 13 (minimum); 14 to 19 (light); 20 to 28 (moderate); > 28 (severe [78]). Note that there is no validated threshold in adults to define a depressive episode characterized.

It has a very good level of internal consistency and reproducibility: the Cronbach Alpha coefficient is high from 0.83 to 0.96 according to the studies in a review of the 2013 literature, this is also the case in French

3 month
Effect of anxiety on alexithymia using the State Trait Anxiety Inventory-YA
Time Frame: 3 months

Effect of anxiety on alexithymia at 3 month, using the State Trait Anxiety Inventory-YA (STAI-YA) The STAI is a Likert type self-questionnaire assessing anxiety that includes two scales: the STAI forms Y-A for "anxiety-state" (AE) and the YB form for "anxiety-trait" (AT) . Each scale is composed of 20 propositions: the scale E (State) relative to what the subject feels on the moment and the scale T (Line) relating to what the subject generally feels [81].

Each item has a score ranging from 1 to 4 (4 being the highest degree of anxiety). We thus obtain the score AE which is the sum of the 20 questions of the page relative to the state and which varies from 20 to 80 as well as the score AT is the sum of the 20 questions of the page "Trait" which also varies from 20 to 80. We will therefore find a very high score (> to 65), high (from 56 to 65), average (from 46 to 55), low (from 36 to 45) or very low (≤35).

3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Clara Letamendia, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 11, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe