AlexithymiaALEXARTNCT04206930
Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder
A study testing Art Therapy in people with Alexithymia and Alcohol Use Disorder, run by University Hospital, Angers at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alexithymia, Alcohol Use Disorder
- What is being tested?
- Art Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2019to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire
Angers, 49033
ANAIS MOREAU, 02 41 35 37 72, Anais.Moreau@chu-angers.fr
LAURENT SAMSON, LaSamson@chu-angers.fr
About this study
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.
Read the 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.
- Conditions
- Alexithymia, Alcohol Use Disorder
- Being tested
- Art Therapy
- Medical subject headings
- Affective Symptoms, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyOther
1 session of 2 hours per week in a closed group for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Art Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start13 Dec 2019
- Primary completion7 Jan 2020 (estimated)
- Study completion13 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlexithymiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- BENEDICTE GOHIER, Study director, CHU ANGERS SERVICE DE PSYCHIATRIE ADDICTOLOGIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206930
- Sponsor's protocol ID
- 2017-A02031-52
- Acronym
- ALEXART
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04206930
- Acronym / sponsor ID
- ALEXART / 2017-A02031-52
- Conditions
- Alexithymia, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 7 Jan 2020 (estimated)
- Study completion
- 13 Dec 2022 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard support: information on alcoholic pathology, medico-psycho-social assessment, relapse prevention program |
| Art-Therapy | Experimental | Other: Art Therapyin addition to standard treatment, art therapy treatment program: 1 session of 2 hours per week in a closed group for 10 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- Non-understanding of the French language
- Non-affiliation to a social security scheme
- Major cognitive impairment
- Motor problems preventing walking
- Protective patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art Therapy1 session of 2 hours per week in a closed group for 10 weeks | Other | Art-Therapy |
Primary outcome
Echelle de Toronto (TAS)
Time frame: 3 month after inclusion
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BENEDICTE GOHIER study director
CHU ANGERS SERVICE DE PSYCHIATRIE ADDICTOLOGIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy in people with Alexithymia and Alcohol Use Disorder, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANAIS MOREAU (02.41.35.37.72, Anais.Moreau@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echelle de Toronto (TAS) (time frame: 3 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.