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Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder (ALEXART)

Primary Purpose

Alexithymia, Alcohol Use Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Art Therapy
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alexithymia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier UniversitaireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Art-Therapy

Arm Description

Standard support: information on alcoholic pathology, medico-psycho-social assessment, relapse prevention program

in addition to standard treatment, art therapy treatment program: 1 session of 2 hours per week in a closed group for 10 weeks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 18, 2019
Last Updated
December 18, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04206930
Brief Title
Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder
Acronym
ALEXART
Official Title
Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
January 7, 2020 (Anticipated)
Study Completion Date
December 13, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alexithymia, Alcohol Use Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard support: information on alcoholic pathology, medico-psycho-social assessment, relapse prevention program
Arm Title
Art-Therapy
Arm Type
Experimental
Arm Description
in addition to standard treatment, art therapy treatment program: 1 session of 2 hours per week in a closed group for 10 weeks
Intervention Type
Other
Intervention Name(s)
Art Therapy
Intervention Description
1 session of 2 hours per week in a closed group for 10 weeks
Primary Outcome Measure Information:
Title
Echelle de Toronto (TAS)
Description
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).
Time Frame
3 month after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANAIS MOREAU
Phone
02.41.35.37.72
Email
Anais.Moreau@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
LAURENT SAMSON
Phone
06.65.80.75.82
Email
LaSamson@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BENEDICTE GOHIER
Organizational Affiliation
CHU ANGERS SERVICE DE PSYCHIATRIE ADDICTOLOGIE
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANAIS MOREAU
Phone
02 41 35 37 72
Email
Anais.Moreau@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
LAURENT SAMSON
Email
LaSamson@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
ANAIS MOREAU

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder

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