Evaluation of a Therapeutic Education Programme for Harm Reduction in People With Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Community-validated alcohol-related harms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •fluent in French speaker
- •able to provide written, informed consent
- •reachable by phone
- •followed-up for Alcohol Use Disorder
排除标准
- •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
结局指标
主要结局
Community-validated alcohol-related harms
时间窗: Compared after 6 months between the intervention- and the control group.
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.
次要结局
- Self-confidence to resist drinking (Brief Situational Confidence Questionnaire)(Compared after 6 months between the intervention- and the control group.)
- Coping strategies (Brief COPE)(Compared after 6 months between the intervention- and the control group.)
- Capability (ICECAP-A questionnaire)(Compared after 6 months between the intervention- and the control group.)
- Treatment self-regulation(Compared after 6 months between the intervention- and the control group.)
- Health-related Quality of life (SF-12v2 health survey)(Compared after 6 months between the intervention- and the control group.)
- Stigma(Compared after 6 months between the intervention- and the control group.)
- Average alcohol consumption (AUDIT-C)(Compared after 6 months between the intervention- and the control group.)
- Craving(Compared after 6 months between the intervention- and the control group.)
- Anxiety and depressive symptoms (HAD)(Compared after 6 months between the intervention- and the control group.)
- Alcohol-Related Neuropsychological Impairments (BEARNI)(Compared after 6 months in the intervention group)