An observational study in Alcohol Use Disorder, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational
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.
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 110 is below the median of 159 across 183 observational studies indexed under Alcoholism.
Browse Alcoholism studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consist in adults with alcohol use disorder eligible to participate to a therapeutic patient education programme.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Semi-structured interviews with people who already completed the TPE programme
Behavioral: "Choizitaconso" - therapeutic patient education programme
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
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.
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.
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.
Time frame: Compared after 6 months between the intervention- and the control group.
Health-related Quality of life (SF-12v2 health survey)
A validated measure of physical and mental
Time frame: Compared after 6 months between the intervention- and the control group.
Average alcohol consumption (AUDIT-C)
Frequency and quantity of alcohol use
Time frame: Compared after 6 months between the intervention- and the control group.
Craving
Self-reported control over alcohol consumption, and feelings related to alcohol (5 questions)
Time frame: Compared after 6 months between the intervention- and the control group.
Stigma
11 questions on anticipated and internalized stigma drawn from the Substance Use Stigma Mechanism Scale (SU-SMS)
Time frame: Compared after 6 months between the intervention- and the control group.
Anxiety and depressive symptoms (HAD)
HAD anxiety and depressive symptoms scale
Time frame: Compared after 6 months between the intervention- and the control group.
Alcohol-Related Neuropsychological Impairments (BEARNI)
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
Time frame: Compared after 6 months in the intervention group
Coping strategies (Brief COPE)
28 questions on cognitive and behavioural efforts to cope with stress in everyday life (trait coping)
Time frame: Compared after 6 months between the intervention- and the control group.
Capability (ICECAP-A questionnaire)
A measure of wellbeing for the general adult population, used in economic evaluations. 5 questions on attachment, stability, achievement, enjoyment and autonomy
Time frame: Compared after 6 months between the intervention- and the control group.
Treatment self-regulation
Reasons for entering treatment or engaging in healthy behaviour Adaptation of the "Treatment Questionnaire Concerning Diabetes" including 2 subscales: autonomous regulation and controlled regulation
Time frame: Compared after 6 months between the intervention- and the control group.
Self-confidence to resist drinking (Brief Situational Confidence Questionnaire)
Confidence to resist (or control) drinking in high-risk situations
Time frame: Compared after 6 months between the intervention- and the control group.
Plan to share: No
Ran from Oct 2019 to primary completion in Jul 2021, 21 months.
Of 74 non-industry observational studies under Alcoholism, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 65. This study's 21 months is below that.
Counting every sponsor, half of 76 studies reached it within 40 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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