- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524443
Evaluation of Art-therapy on Alexithymia in Patients Suffering From Anorexia Nervosa and From Bulimia (ALEXART)
Evaluation of Art-therapy on Alexithymia in Patients Suffering From Anorexia Nervosa and From Bulimia,a Pilot Study
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- University Hospital toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Clara Letamendia, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/18/0180
- 2018-A01285-50 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.