NCT03954054

Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	"Choizitaconso" - therapeutic patient 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.

Timeline

• Start date: 2019-10-28
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2019-05-17
• Last updated: 2025-11-18

Locations

3 sites across 1 country: France