Clinical trial NCT06140472: PHOENIX: Craving Management Smartphone Application
Official title: Effectiveness of the PHOENIX Smartphone Application on the Nursing Management of Craving in Patients With Addictive Disorders Followed on an Outpatient Basis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Craving
Keywords: Addiction
Craving
Mobile application
Craving management
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2023-11-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: median craving intensity at 6 months
timeFrame: 6 months visit
Secondary outcomes:
measure: Number of cravings
timeFrame: 0,3,6 and 12 months visit
measure: Daily frequency of cravings
timeFrame: 0,3,6 and 12 months
measure: Median of the intensity of the cravings
timeFrame: 0, 3, and 12 months visit
measure: Number of addictive behavioural episodes
timeFrame: 0,3,6 and 12 months
measure: Frequency of addictive behavioural episodes
timeFrame: 0,3,6 and 12 months
measure: Type of addictive behavioural episodes
timeFrame: 0,3,6 and 12 months visit
measure: Severity of addictive disorder: addictive substance disorder or pathological gambling
timeFrame: 0,3,6 and 12 months
measure: Severity of addictive disorder: Yale Food Addiction Scale (YFAS) food addiction score for bulimia nervosa
timeFrame: 0 and 12 months visit
measure: Severity of addictive disorder: sexual addiction (Carnes criteria)
timeFrame: 0,3,6 and 12 months visit
measure: Impulsivity (UPPS scale)
timeFrame: 0,3,6 and 12 months
measure: Number of strategies to deal with craving according to the type of addictive behaviour
timeFrame: 0,3,6 and 12 months
measure: Multidimensional evaluation of coping (Brief Cope scale by Muller and Spitz)
timeFrame: 0,3,6 and 12 months
measure: Anxiety: Beck's inventory for anxiety (BAI)
timeFrame: 0,3,6 and 12 months
measure: Depression: Beck's depression inventory
timeFrame: 0,3,6 and 12 months
measure: Quality of life: World Health Organization Quality of Life (WHOQOL 26 scale)
timeFrame: 0,3,6 and 12 months
measure: Self-esteem (Coopersmith inventory)
timeFrame: 0,3,6 and 12 months
measure: Use of healthcare related to addictive disorder: Hospitalisation
timeFrame: 0,3,6 and 12 months
measure: Use of healthcare related to addictive disorder: emergency department accesses
timeFrame: 0,3,6 and 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civiles de Lyon
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Centre Hospitalier St Anne
name: Chloe Lucet, PH
role: PRINCIPAL_INVESTIGATOR
References: