Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— ETHER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954054
• Other study ID #: C19-03 / ETHER
• Status: Completed
• Start date: October 28, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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: 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.

Locations

Country	Name	City	State
France	CSAPA Convergence	Avignon
France	ANPAA 04	Digne-les-Bains
France	Clinique Saint Barnabé	Marseille

Sponsors (3)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Regional Agency for Health PACA, SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Average alcohol consumption (AUDIT-C)	Frequency and quantity of alcohol use	Compared after 6 months between the intervention- and the control group.
Secondary	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.
Secondary	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.
Secondary	Anxiety and depressive symptoms (HAD)	HAD anxiety and depressive symptoms scale	Compared after 6 months between the intervention- and the control group.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.