Effectiveness of the PHOENIX Smartphone Application on the Nursing Management of Craving in Patients With Addictive Disorders Followed on an Outpatient Basis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- median craving intensity at 6 months
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of the addition of nursing follow-up and the PHOENIX application, a personalized and self-adaptive Smartphone application, on the management of craving in patients with addictive disorders followed on an outpatient basis.
详细描述
Addictive disorders are a public health priority. The management of addictive disorders aims to reduce addictive behaviour or abstinence, implying that the patient can overcome the urge to engage in this behaviour, a symptom called craving.
Craving, as a major motivational substrate for addictive behaviour, is a preferred therapeutic target for the management of addictive disorders. However, to date, there are no fully effective drugs or psychological interventions. Smartphone applications seem to have an interest in this context, with many advantages: accessibility, anonymity, ease of access and low cost. Sainte Anne's Hospital Moreau de Tour facility (Paris, France) was one of the pioneering centres in the management of addictive disorders. The nursing team has developed expertise in this field. Patients report difficulties to nurses about managing their craving on their own, and ask for more frequent interviews or even daily support. During practice analysis meetings, caregivers sought innovative solutions to optimize this care. Our team has designed the PHOENIX application, which allows us to support patients in real time who wish to reduce or stop their addictive behaviours. Used between two consultations, it targets craving, without being specific to a product or addictive behaviour. When the patient has a craving, PHOENIX identifies the situation and proposes the most appropriate strategy to avoid using. Strategies are personalized and self-adaptive. The application allows caregivers to monitor patients' progress and progress.
Hypothesis of this study: The PHOENIX application used as a complement to nursing care will allow a better management of craving and a decrease in relapses compared to usual care (usual care: multidisciplinary care including nursing care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 and 65 years old, any sex
- •Speak and read French
- •Have a Smartphone (Android operating system or IOS)
- •Present an evaluated addictive disorder in a structured clinical interview (MINI, adapted to the criteria of DSM-5: substance use disorder according to DSM-5 and bulimia nervosa; National Opinion DSM Screen (NODS), adapted to the criteria of DSM-5: pathological gambling; NODS, adapted to the diagnostic criteria proposed by Carnes: sexual addiction ; MINI)
- •Be followed on an outpatient basis
- •Prior informed written consent of the patient or his or her legal representative
- •Benefit from a French social protection system
排除标准
- •Have a current untreated and/or unstabilized psychiatric disorder (assessed by MINI)
- •Have a severe cognitive impairment assessed during the clinical interview, which does not allow you to focus your attention or use the working memory required by the application.
- •Pregnant or breastfeeding women
- •Participant in another clinical trial
结局指标
主要结局
median craving intensity at 6 months
时间窗: 6 months visit
Measurement of craving intensity with an analog visual scale (AVS) between 0 (no craving) and 10 (maximum imaginable craving), informed during craving episodes by the patient via the PHOENIX application or the electronic journal. Over the last 30 days before the visit at 6 months
次要结局
- Severity of addictive disorder: Yale Food Addiction Scale (YFAS) food addiction score for bulimia nervosa(0 and 12 months visit)
- Impulsivity (UPPS scale)(0,3,6 and 12 months)
- Type of addictive behavioural episodes(0,3,6 and 12 months visit)
- Number of cravings(0,3,6 and 12 months visit)
- Severity of addictive disorder: addictive substance disorder or pathological gambling(0,3,6 and 12 months)
- Number of strategies to deal with craving according to the type of addictive behaviour(0,3,6 and 12 months)
- Use of healthcare related to addictive disorder: Hospitalisation(0,3,6 and 12 months)
- Daily frequency of cravings(0,3,6 and 12 months)
- Median of the intensity of the cravings(0, 3, and 12 months visit)
- Multidimensional evaluation of coping (Brief Cope scale by Muller and Spitz)(0,3,6 and 12 months)
- Quality of life: World Health Organization Quality of Life (WHOQOL 26 scale)(0,3,6 and 12 months)
- Number of addictive behavioural episodes(0,3,6 and 12 months)
- Frequency of addictive behavioural episodes(0,3,6 and 12 months)
- Severity of addictive disorder: sexual addiction (Carnes criteria)(0,3,6 and 12 months visit)
- Depression: Beck's depression inventory(0,3,6 and 12 months)
- Use of healthcare related to addictive disorder: emergency department accesses(0,3,6 and 12 months)
- Anxiety: Beck's inventory for anxiety (BAI)(0,3,6 and 12 months)
- Self-esteem (Coopersmith inventory)(0,3,6 and 12 months)