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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

Tracking Information
First Submitted Date May 2, 2018
First Posted Date May 14, 2018
Last Update Posted Date August 15, 2018
Estimated Study Start Date October 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2018)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03524443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 11, 2018)
  • 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.
  • 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
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Art-therapy on Alexithymia in Patients Suffering From Anorexia Nervosa and From Bulimia
Official Title Evaluation of Art-therapy on Alexithymia in Patients Suffering From Anorexia Nervosa and From Bulimia,a Pilot Study
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Anorexia Nervosa/Bulimia
Intervention 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

Study Groups/Cohorts 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
Intervention: Behavioral: Art Therapy treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 11, 2018)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03524443
Other Study ID Numbers RC31/18/0180
2018-A01285-50 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor University Hospital, Toulouse
Collaborators Not Provided
Investigators
Principal Investigator: Clara Letamendia, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date August 2018