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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04206930
Other study ID # 2017-A02031-52
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 13, 2019
Est. completion date December 13, 2022

Study information

Verified date December 2019
Source University Hospital, Angers
Contact ANAIS MOREAU
Phone 02.41.35.37.72
Email Anais.Moreau@chu-angers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Art therapy support combined with standard care for people with an alcohol use disorder coming to a day hospital for withdrawal could be beneficial compared to standard care alone because it would improve the alexithymia of these patients, helping them to better identify their feelings and / or emotions, and improve their self-confidence, their self-esteem self and their oral communication.


Description:

Alexithymia is an inability to identify and describe one's emotions associated with outward thinking. Frequently found in people with an alcohol use disorder, a true mental handicap, alexithymia has been clearly identified as a relapse factor in addictive problems related to alcohol. The ALEXART study intends to study the evolution of alexithymia in people with an alcohol use disorder hosted in an Addictology Day Hospital unit through the use of an approach non-drug that is art therapy. Our hypothesis is that art therapy can help patients with alcohol use disorders to develop a better understanding of their own behaviors, to name their emotions and feelings, and to improve their communication with others and thereby be able to choose to change their behavior.


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date December 13, 2022
Est. primary completion date January 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Adult 18 or over

- Patient with an alcohol use disorder starting day hospital care in the psychiatry and addiction department of the Angers University Hospital

- Subjects who gave and signed informed consent to participate in the study with alexithymia (Toronto Test greater than or equal to 56)

Exclusion Criteria:

- Non-understanding of the French language

- Non-affiliation to a social security scheme

- Major cognitive impairment

- Motor problems preventing walking

- Protective patients

- Pregnant or lactating women

- Patients under protection of justice or deprived of liberty

- Patients under protective supervision or guardianship

Study Design


Intervention

Other:
Art Therapy
1 session of 2 hours per week in a closed group for 10 weeks

Locations

Country Name City State
France Centre Hospitalier Universitaire Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Echelle de Toronto (TAS) self-questionnaire which includes 20 items and allows to measure 3 factors:
Difficulty identifying feelings (TAS 1).
Difficulty expressing feelings (TAS 2).
Outward-oriented thinking (TAS 3).
3 month after inclusion
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