Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder

NCT03954054 | Completed

• 1 other identifier: C19-03 / ETHER
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

Alcohol is the most harmful psychoactive substance in terms of overall damage. Although abstinence remains the objective of most pharmacological and non-pharmacological approaches addressing alcohol use disorder (AUD), new therapeutic objectives of reduced alcohol intake and controlled-drinking have emerged. ETHER ("Education THEérapeutique pour la Réduction des dommages en alcoologie" or therapeutic education for the reduction of alcohol-related harms) is an ongoing, multicentre, community-based mixed-methods study, which aims to evaluate the innovative therapeutic patient education (TPE) programme named "Choizitaconso". This programme teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms. The evaluation of the programme will rely on a sequential explanatory design, where the qualitative study (16 semi-structured interviews) will assist in explaining and interpreting the findings of the controlled before-and-after quantitative study.

Conditions

Alcohol Use Disorder

Keywords

alcohol; substance use; patient education; psychosocial skills; controlled drinking; harm reduction; abstinence; quality of life

Outcome Measures

Primary Outcomes (1)

• Community-validated alcohol-related harms

  We selected as principal outcome the number of experienced alcohol-related harms (ranging between 0 and 34) as a measure of the individual alcohol-related "burden". 34 questions on alcohol-related harms (physical, social and behavioural consequences) were identified by and with the community of PWAUD during several working sessions. Alcohol-related harms assessment is scheduled at enrolment (i.e., before the TPE programme initiation for the intervention group) and 6 months later.

  Compared after 6 months between the intervention- and the control group.

Secondary Outcomes (10)

• Health-related Quality of life (SF-12v2 health survey)

  Compared after 6 months between the intervention- and the control group.

• Average alcohol consumption (AUDIT-C)

  Compared after 6 months between the intervention- and the control group.

• Craving

  Compared after 6 months between the intervention- and the control group.

• Stigma

  Compared after 6 months between the intervention- and the control group.

• Anxiety and depressive symptoms (HAD)

  Compared after 6 months between the intervention- and the control group.

Study Arms (3)

Former therapeutic education participants

Semi-structured interviews with people who already completed the TPE programme

Behavioral: "Choizitaconso" - therapeutic patient education programme

Intervention group (current therapeutic education participants)

A face-to-face interview and a telephone interview at treatment initiation (M0) and 6 months after programme initiation (M6) Administration of socio-economic questionnaires and a Brief Evaluation of Alcohol-Related Neuropsychological Impairment (BEARNI) before, and 6 months after inclusion in the therapeutic education programme.

Behavioral: "Choizitaconso" - therapeutic patient education programme

Control AUD (Alcohol Use Disorder) patients

A face-to-face interview and a telephone interview at treatment initiation (M0) and 6 months after programme initiation (M6) Administration of socio-economic questionnaires and a Brief Evaluation of Alcohol-Related Neuropsychological Impairment (BEARNI) before, and 6 months after inclusion in the therapeutic education programme.

Interventions

"Choizitaconso" - therapeutic patient education programme BEHAVIORAL

Choizitaconso is a therapeutic patient education programme that teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms. It lasts for 10 weeks for each participant and consists of the following 5 modules, including one optional module focusing on the family environment: 1. Understand the mechanisms that trigger and/or maintain alcohol-related difficulties 2. Plan and evaluate personalized controlled drinking strategies 3. Understand and identify external and internal influences (e.g., thoughts and emotions), identify and manage risk situations 4. Identify alcohol effects and alcohol-related expectations (by developing self-observation skills) 5. Family environment: learning how to evaluate and take care of oneself (e.g., how to express feelings) Each module consists of 2 to 4 collective workshops that each last 120 minutes and involve 5 to 10 persons.

Former therapeutic education participants; Intervention group (current therapeutic education participants)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consist in adults with alcohol use disorder eligible to participate to a therapeutic patient education programme.

You may qualify if:

• at least 18 years old
• fluent in French speaker
• able to provide written, informed consent
• reachable by phone
• followed-up for Alcohol Use Disorder

You may not qualify if:

• cocaine or opiate dependence
• being a legally-protected adult (tutorship, curatorship)
• being pregnant
• participation in another study during the duration of follow-up (6 months)
• having severe cognitive impairment which could conflict with successful group work

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Regional Agency for Health PACA: collaborator
• SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD): collaborator

Study Sites (3)

CSAPA Convergence

Avignon, 84000, France

Location

ANPAA 04

Digne-les-Bains, France

Location

Clinique Saint Barnabé

Marseille, 13015, France

Location

Related Publications (2)

• Barre T, Ramier C, Antwerpes S, Costa M, Bureau M, Maradan G, Di Beo V, Cutarella C, Leloutre J, Riccobono-Soulier O, Hedoire S, Frot E, Vernier F, Vassas-Goyard S, Dufort S, Protopopescu C, Marcellin F, Casanova D, Coste M, Carrieri P. A novel community-based therapeutic education program for reducing alcohol-related harms and stigma in people with alcohol use disorders: A quasi-experimental study (ETHER study). Drug Alcohol Rev. 2023 Mar;42(3):664-679. doi: 10.1111/dar.13605. Epub 2023 Jan 31.

  PMID: 36721903 RESULT

• Antwerpes S, Costa M, Coste M, Bureau M, Maradan G, Cutarella C, Leloutre J, Riccobono-Soulier O, Hedoire S, Frot E, Vernier F, Vassas-Goyard S, Barre T, Casanova D, Carrieri P. Evaluation of a novel therapeutic education programme for people with alcohol use disorder in France: a mixed-methods intervention study protocol (ETHER). Harm Reduct J. 2022 Jan 10;19(1):2. doi: 10.1186/s12954-021-00587-0.

  PMID: 35012570 RESULT

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders; Harm Reduction

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 17, 2019
• Study Start: October 28, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: November 18, 2025

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)