Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder

Study Overview
=================
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.

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.

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

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Choizitaconso - therapeutic patient education programme


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Former therapeutic education participants<br>Semi-structured interviews with people who already completed the TPE programme | Behavioral: Choizitaconso - therapeutic patient education programme<br>* 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.<br>|
| Intervention group (current therapeutic education participants)<br>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<br>* 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.<br>|
| Control AUD (Alcohol Use Disorder) patients<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of life (SF-12v2 health survey) | A validated measure of physical and mental | Compared after 6 months between the intervention- and the control group. | 
| Average alcohol consumption (AUDIT-C) | Frequency and quantity of alcohol use | 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) | 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) | Compared after 6 months between the intervention- and the control group. | 
| Anxiety and depressive symptoms (HAD) | HAD anxiety and depressive symptoms scale | 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 | 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) | 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 | 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 | 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 | Compared after 6 months between the intervention- and the control group. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol, substance use, patient education, psychosocial skills, controlled drinking, harm reduction, abstinence, quality of life