- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206930
Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder (ALEXART)
December 18, 2019 updated by: University Hospital, Angers
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Angers, France, 49033
- Recruiting
- Centre Hospitalier Universitaire
-
Contact:
- ANAIS MOREAU
- Phone Number: 02 41 35 37 72
- Email: Anais.Moreau@chu-angers.fr
-
Contact:
- LAURENT SAMSON
- Email: LaSamson@chu-angers.fr
-
Principal Investigator:
- ANAIS MOREAU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Standard support: information on alcoholic pathology, medico-psycho-social assessment, relapse prevention program
|
|
|
Experimental: Art-Therapy
in addition to standard treatment, art therapy treatment program: 1 session of 2 hours per week in a closed group for 10 weeks
|
1 session of 2 hours per week in a closed group for 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Echelle de Toronto (TAS)
Time Frame: 3 month after inclusion
|
self-questionnaire which includes 20 items and allows to measure 3 factors:
|
3 month after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: BENEDICTE GOHIER, CHU ANGERS SERVICE DE PSYCHIATRIE ADDICTOLOGIE
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2019
Primary Completion (Anticipated)
January 7, 2020
Study Completion (Anticipated)
December 13, 2022
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
December 18, 2019
First Posted (Actual)
December 20, 2019
Study Record Updates
Last Update Posted (Actual)
December 20, 2019
Last Update Submitted That Met QC Criteria
December 18, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A02031-52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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