Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder (ETHER)

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

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Behavioral: "Choizitaconso" - therapeutic patient education programme

Study type: Observational

Funder types: Other

Identifiers

NCT03954054

C19-03 / ETHER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 3 patient groups

Former therapeutic education participants

Description:

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

Treatment:

Behavioral: "Choizitaconso" - therapeutic patient education programme

Intervention group (current therapeutic education participants)

Description:

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.

Treatment:

Behavioral: "Choizitaconso" - therapeutic patient education programme

Control AUD (Alcohol Use Disorder) patients

Description:

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.