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Completed

NCT Number: NCT03954054

Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Harm Reduction Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CSAPA Convergence, Avignon, France

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About this study

ETHER's quantitative component is a 6-month controlled study which evaluates the effectiveness of "Choizitaconso" by comparing 30 PWAUD following the programme with a control group of 60 PWAUD not following it. All 90 PWAUD are individually interviewed using standardized face-to-face and phone-based interviews.

34 questions on alcohol-related harms were identified in the international literature and approved by the PWAUD community. The sum of these harms, considered as a measure of the individual "burden" related to alcohol use, will be used as principal outcome.

Secondary outcomes are quantity and frequency of alcohol consumption, craving for alcohol, coping strategies, Health-Related Quality of Life (HRQL), self-confidence to resist drinking, anticipated and internalized stigma, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments and capabilities (i.e., a measure of wellbeing for the general adult population, used in economic evaluations).

Primary and secondary outcomes will be collected in face-to-face and phone-based interviews at enrolment and 6 months after enrolment. We will use a binomial test and linear regression models to assess the impact of the TPE programme on changes in the principal and secondary outcomes, while adjusting for other correlates and confounders.

The study's qualitative component comprises semi-structured interviews of 16 PWAUD who completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

"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:

  • Understand the mechanisms that trigger and/or maintain alcohol-related difficulties
  • Plan and evaluate personalized controlled drinking strategies
  • Understand and identify external and internal influences (e.g., thoughts and emotions), identify and manage risk situations
  • Identify alcohol effects and alcohol-related expectations (by developing self-observation skills)
  • 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.

Primary outcomes

  1. Community-validated alcohol-related harms

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

    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.

Secondary outcomes

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

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

    A validated measure of physical and mental

  2. Average alcohol consumption (AUDIT-C)

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

    Frequency and quantity of alcohol use

  3. Craving

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

    Self-reported control over alcohol consumption, and feelings related to alcohol (5 questions)

  4. Stigma

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

    11 questions on anticipated and internalized stigma drawn from the Substance Use Stigma Mechanism Scale (SU-SMS)

  5. Anxiety and depressive symptoms (HAD)

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

    HAD anxiety and depressive symptoms scale

  6. Alcohol-Related Neuropsychological Impairments (BEARNI)

    Time frame: Compared after 6 months in the intervention group

    The Brief Evaluation of Alcohol-Related Neuropsychological Impairment (BEARNI) test is a clinical screening tool, assessing verbal episodic memory, visuospatial abilities, working memory, executive functioning

  7. Coping strategies (Brief COPE)

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

    28 questions on cognitive and behavioural efforts to cope with stress in everyday life (trait coping)

  8. Capability (ICECAP-A questionnaire)

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

    A measure of wellbeing for the general adult population, used in economic evaluations.

    5 questions on attachment, stability, achievement, enjoyment and autonomy

  9. Treatment self-regulation

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

    Reasons for entering treatment or engaging in healthy behaviour Adaptation of the "Treatment Questionnaire Concerning Diabetes" including 2 subscales: autonomous regulation and controlled regulation

  10. Self-confidence to resist drinking (Brief Situational Confidence Questionnaire)

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

    Confidence to resist (or control) drinking in high-risk situations

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • Regional Agency for Health PACA
  • SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD)

Registry information

Official study title

Evaluation of a Therapeutic Education Programme for Harm Reduction in People With Alcohol Use Disorder

Acronym: ETHER

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 17, 2019
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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