PHOENIX: Craving Management Smartphone Application

NCT ID: NCT06140472

Last Updated: 2023-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2024-06-30

Brief Summary

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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

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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).

Conditions

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Craving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Phoenix application

Specific individualized nurse follow-up using the PHOENIX application.

Group Type ACTIVE_COMPARATOR

Phoenix

Intervention Type BEHAVIORAL

Specific individualized nurse follow-up using the PHOENIX application.

Journal de bord

Regular nursing follow-up, with the use of an electronic journal.

Group Type SHAM_COMPARATOR

Journal de bord

Intervention Type BEHAVIORAL

Regular nursing follow-up, with the use of an electronic journal.

Interventions

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Phoenix

Specific individualized nurse follow-up using the PHOENIX application.

Intervention Type BEHAVIORAL

Journal de bord

Regular nursing follow-up, with the use of an electronic journal.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier St Anne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chloe Lucet, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier St Anne

Locations

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Hospices Civiles de Lyon

Lyon, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julie Dupouy, Nurse

Role: CONTACT

01.45.65.80.64 ext. +33

Stephane Geyssens, Ing

Role: CONTACT

01.45.65.61.40

Facility Contacts

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Clara SICARD, Nurse

Role: primary

Julie Caillion, Nurse

Role: primary

Other Identifiers

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D19-P019

Identifier Type: -

Identifier Source: org_study_id

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