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

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ClinicalTrials.gov Identifier: NCT03524443
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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.

Condition or disease Intervention/treatment
Anorexia Nervosa/Bulimia Behavioral: Art Therapy 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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Art-therapy on Alexithymia in Patients Suffering From Anorexia Nervosa and From Bulimia,a Pilot Study
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

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
Behavioral: Art Therapy treatment

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





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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. 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).




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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524443


Contacts
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Contact: Clara LETAMENDIA, MD 05 34 55 75 25 ext 33 letamendia.c@chu-toulouse.fr
Contact: Isabelle Olivier, PhD 05 61 77 70 51 ext 33 olivier.i@chu-toulouse.fr

Locations
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France
University Hospital Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Clara Letamendia, MD    05 34 55 75 25 ext 33    letamendia.c@chu-toulouse.fr   
Contact: Isabelle Olivier, PhD    05 61 77 70 51 ext 33    olivier.i@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Clara Letamendia, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03524443     History of Changes
Other Study ID Numbers: RC31/18/0180
2018-A01285-50 ( Other Identifier: ID-RCB )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Affective symptom
Art Therapy
alexithymia
emotional disturbance
hyperphagia
psychotherapy
rehabilitation
factor of resistance
Additional relevant MeSH terms:
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Anorexia
Bulimia
Anorexia Nervosa
Bulimia Nervosa
Behavioral Symptoms
Feeding and Eating Disorders
Mental Disorders
Hyperphagia
Affective Symptoms
Signs and Symptoms, Digestive
Signs and Symptoms