Clinical trial NCT03954054: Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder
Official title: Evaluation of a Therapeutic Education Programme for Harm Reduction in People With Alcohol Use Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Use Disorder
Keywords: alcohol
substance use
patient education
psychosocial skills
controlled drinking
harm reduction
abstinence
quality of life
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Regional Agency for Health PACA
name: SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD)
First posted: 2019-05-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consist in adults with alcohol use disorder eligible to participate to a therapeutic patient education programme.

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.

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

Primary outcomes:
measure: Community-validated alcohol-related harms
timeFrame: Compared after 6 months between the intervention- and the control group.
Secondary outcomes:
measure: Health-related Quality of life (SF-12v2 health survey)
timeFrame: Compared after 6 months between the intervention- and the control group.
measure: Average alcohol consumption (AUDIT-C)
timeFrame: Compared after 6 months between the intervention- and the control group.
measure: Craving
timeFrame: Compared after 6 months between the intervention- and the control group.
measure: Stigma
timeFrame: Compared after 6 months between the intervention- and the control group.
measure: Anxiety and depressive symptoms (HAD)
timeFrame: Compared after 6 months between the intervention- and the control group.
measure: Alcohol-Related Neuropsychological Impairments (BEARNI)
timeFrame: Compared after 6 months in the intervention group
measure: Coping strategies (Brief COPE)
timeFrame: Compared after 6 months between the intervention- and the control group.
measure: Capability (ICECAP-A questionnaire)
timeFrame: Compared after 6 months between the intervention- and the control group.
measure: Treatment self-regulation
timeFrame: Compared after 6 months between the intervention- and the control group.
measure: Self-confidence to resist drinking (Brief Situational Confidence Questionnaire)
timeFrame: Compared after 6 months between the intervention- and the control group.
Other outcomes:
Locations:
city: Avignon
country: France
facility: CSAPA Convergence
city: Digne-les-Bains
country: France
facility: ANPAA 04
city: Marseille
country: France
facility: Clinique Saint Barnabé
Study officials:
References:
citation: Antwerpes S, Costa M, Coste M, Bureau M, Maradan G, Cutarella C, Leloutre J, Riccobono-Soulier O, Hedoire S, Frot E, Vernier F, Vassas-Goyard S, Barre T, Casanova D, Carrieri P. Evaluation of a novel therapeutic education programme for people with alcohol use disorder in France: a mixed-methods intervention study protocol (ETHER). Harm Reduct J. 2022 Jan 10;19(1):2. doi: 10.1186/s12954-021-00587-0.