NCT04206930

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.

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
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

25 days

First QC Date

December 18, 2019

Last Update Submit

December 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control

NO INTERVENTION

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

Art-Therapy

EXPERIMENTAL

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

Other: Art Therapy

Interventions

1 session of 2 hours per week in a closed group for 10 weeks

Art-Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Angers, 49033, France

RECRUITING

MeSH Terms

Conditions

Affective SymptomsAlcoholism

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • BENEDICTE GOHIER

    CHU ANGERS SERVICE DE PSYCHIATRIE ADDICTOLOGIE

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 20, 2019

Study Start

December 13, 2019

Primary Completion

January 7, 2020

Study Completion

December 13, 2022

Last Updated

December 20, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations