NCT03524443

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

May 2, 2018

Last Update Submit

August 13, 2018

Conditions

Keywords

Affective symptomArt Therapyalexithymiaemotional disturbancehyperphagiapsychotherapyrehabilitationfactor of resistance

Outcome Measures

Primary Outcomes (1)

  • Alexithymia rate using de Toronto Alexithymia Scale

    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 Outcomes (3)

  • Body Mass Index (BMI) evolution for anorexic patient

    3 months

  • Effect of depression on alexithymia using the Beck Depression Inventory-II

    3 month

  • Effect of anxiety on alexithymia using the State Trait Anxiety Inventory-YA

    3 months

Study Arms (1)

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

Interventions

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

Patient suffering from anorexia/bulimia

Eligibility Criteria

Age16 Years+
Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Anorexia NervosaBulimiaAffective SymptomsHyperphagia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Clara Letamendia, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Olivier, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 14, 2018

Study Start

October 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations