CravingPHOENIXNCT06140472
PHOENIX: Craving Management Smartphone Application
A study testing Phoenix and Journal de bord in people with Craving, run by Centre Hospitalier St Anne at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Craving
- What is being tested?
- Phoenix and Journal de bord
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Dec 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hospices Civiles de Lyon
Lyon
Clara SICARD, Nurse
- Recruiting
CHU de Nantes
Nantes
Julie Caillion, Nurse
About this study
Official title: Effectiveness of the PHOENIX Smartphone Application on the Nursing Management of Craving in Patients With Addictive Disorders Followed on an Outpatient Basis
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.
Read the 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).
- Conditions
- Craving
- Being tested
- Phoenix, Journal de bord
- Keywords
- Addiction, Craving, Mobile application, Craving management
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhoenixBehavioural
Specific individualized nurse follow-up using the PHOENIX application.
Journal de bordBehavioural
Regular nursing follow-up, with the use of an electronic journal.
| Study group | Role | What they receive |
|---|---|---|
| Phoenix application | Active comparator | Specific individualized nurse follow-up using the PHOENIX application. Receives: Behavioral: Phoenix |
| Journal de bord | Sham comparator | Regular nursing follow-up, with the use of an electronic journal. Receives: Behavioral: Journal de bord |
What is being measured
The primary outcome is the main question the study is designed to answer.
median craving intensity at 6 months
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
Measured: 6 months visit
Secondary outcomes (18)
Number of cravings
The cravings will be informed by the patient during craving episodes via the PHOENIX application or the electronic journal
Measured: 0,3,6 and 12 months visit
Daily frequency of cravings
The cravings will be informed by the patient during craving episodes via the PHOENIX application or the electronic journal
Measured: 0,3,6 and 12 months
Median of the intensity of the cravings
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 15 days before the visit at 0, 3 and 12 months
Measured: 0, 3, and 12 months visit
Number of addictive behavioural episodes
Addictive behaviors will be informed via the phoenix application or the electronic journal
Measured: 0,3,6 and 12 months
Frequency of addictive behavioural episodes
Addictive behaviors will be informed via the phoenix application or the electronic journal
Measured: 0,3,6 and 12 months
Type of addictive behavioural episodes
Addictive behaviors will be informed via the phoenix application or the electronic journal
Measured: 0,3,6 and 12 months visit
Severity of addictive disorder: addictive substance disorder or pathological gambling
Severity of the disorder assessed by the number of diagnostic criteria for addictive substance disorder or pathological gambling on the Diagnostic and Statistical Manuel of mental disorders (DSM-5).
Measured: 0,3,6 and 12 months
Severity of addictive disorder: Yale Food Addiction Scale (YFAS) food addiction score for bulimia nervosa
Severity of the food addiction for bulimia nervosa is assessed by the Yale Food Addiction Scale (YFAS).
The YFAS assesses addiction-like eating of palatable foods based on the 11 diagnostic criteria for substance use disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). No Food Addiction = 0-1 symptoms/score; Mild Food Addiction = 2 or 3 symptom/score; Moderate Food Addiction = 4 or 5 symptom/score; Severe Food Addiction = 6 or higher symptom/score
Measured: 0 and 12 months visit
Severity of addictive disorder: sexual addiction (Carnes criteria)
Severity of the disorder assessed by the number of positive responses in the Carnes criteria. Carnes criteria consists of 25 yes/no questions. If the answer is "yes" to 13 or more questions, the patient can be diagnosed as a sex addict (range: 0-25).
Measured: 0,3,6 and 12 months visit
Impulsivity (UPPS scale)
Impulsivity is assessed using the UPPS scale (Urgency, Premeditation (lack of), Perseverance (lack of), Sensation seeking. The UPPS impulsivity scale is a 45-item self-questionnaire that measures impulsivity by exploring: urgency (12 items: range 12-48), lack of forethought (11 items; range:11-44), lack of perseverance (10 items; range:10-40) and sensation seeking (12 items; range:12-48). For each subdimension, a high score indicates a high level of impulsivity.
Measured: 0,3,6 and 12 months
Number of strategies to deal with craving according to the type of addictive behaviour
The strategies will be provided through the application or the electronic journal
Measured: 0,3,6 and 12 months
Multidimensional evaluation of coping (Brief Cope scale by Muller and Spitz)
The multidimensional evaluation of coping is carried out using the Brief Coping Orientation to Problems Experienced (Brief COPE) ,28-item self-questionnaire. The Brief COPE contains 28 statements and 14 scales, each consisting of 2 statements. It is a self-administered questionnaire. It is available in 2 formats: 1) dispositional, which is designed to assess how people habitually respond to stressful situations, and 2) situational, which is designed to assess how people responded to a specific event or context that has recently become a source of stress. Only the verb tense varies between statements in the two formats.
The respondent uses a 4-point scale to give his/her answer to each statement: 1 - not at all; 2 - a little; 3 - a lot; 4 - completely.
The answers obtained are added together for each scale. Higher scores on a scale indicate greater use of this coping mechanism.
Measured: 0,3,6 and 12 months
Anxiety: Beck's inventory for anxiety (BAI)
The anxiety assessment is carried out using Beck's inventory for anxiety (BAI). The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory used to measure the severity of anxiety. The questions used in this measure ask to describe common symptoms of anxiety that the subject has experienced in the last week (including the day on which the measure is taken).
The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
The standardized cutoffs are:
0-7: Minimal 8-15: Mild 16-25: Moderate 26-63: Severe
Measured: 0,3,6 and 12 months
Depression: Beck's depression inventory
The Beck Depression Inventory (BDI), is a multiple-choice self-report inventory for measuring the severity of depression.
The BDI, consisted of twenty-one questions about how the subject has been feeling in the last week. Each question had a set of at least four possible responses, ranging in intensity:
(0) I do not feel sad
- I feel sad.
- I am sad all the time, and I cannot snap out of it.
- I am so sad or unhappy that I cannot stand it.
When the test is scored, a value of 0 to 3 is assigned for each answer, and then the total score determines the depression's severity. The standard cut-off scores were as follows:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
Measured: 0,3,6 and 12 months
Quality of life: World Health Organization Quality of Life (WHOQOL 26 scale)
The World Health Organization Quality of Life (WHOQOL26) assesses subjective health-related quality of life in a 26-item self-administered questionnaire.
The WHOQOL26 scale investigates the quality of life in four domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environmental health (8 items); it also contains QOL and general health items. Each item of the WHOQOL26 is scored on a five-point ordinal scale. The scores are then linearly transformed into a 0-100 scale.
Measured: 0,3,6 and 12 months
Self-esteem (Coopersmith inventory)
The Coopersmith's Self-Esteem Inventory assesses general, professional, social and family self-esteem; the total is the sum of these four components. The test comprises 58 items; the responses are "looks like me" or "doesn't look like me." The score is composed of several subscales: General (26 items), Social (8 items), Professional (8 items), Family (8 items) and Lie (8 items). The total score (50 items) is obtained by summing the General, Social, Professional and Family subscales. The Lying scale is more of a social desirability scale used to assess patient authenticity in general assessment.
Measured: 0,3,6 and 12 months
Use of healthcare related to addictive disorder: Hospitalisation
Number of hospitalization days related to addiction
Measured: 0,3,6 and 12 months
Use of healthcare related to addictive disorder: emergency department accesses
Number of emergency department accesses related to addiction
Measured: 0,3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start11 Dec 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CravingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Chloe Lucet, PH, Principal investigator, Centre Hospitalier St Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140472
- Sponsor's protocol ID
- D19-P019
- Acronym
- PHOENIX
- Status last verified
- Nov 2023
- First submitted
- 27 Sep 2019
- Last updated
- 20 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the PHOENIX Smartphone Application on the Nursing Management of Craving in Patients With Addictive Disorders Followed on an Outpatient Basis
- ClinicalTrials.gov ID
- NCT06140472
- Acronym / sponsor ID
- PHOENIX / D19-P019
- Conditions
- Craving
- Keywords
- Addiction, Craving, Mobile application, Craving management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phoenix application | Active comparator | Behavioral: PhoenixSpecific individualized nurse follow-up using the PHOENIX application. |
| Journal de bord | Sham comparator | Behavioral: Journal de bordRegular nursing follow-up, with the use of an electronic journal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhoenixSpecific individualized nurse follow-up using the PHOENIX application. | Behavioural | Phoenix application |
| Journal de bordRegular nursing follow-up, with the use of an electronic journal. | Behavioural | Journal de bord |
Primary outcome
median craving intensity at 6 months
Time frame: 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
18 secondary outcomes
Number of cravings
Time frame: 0,3,6 and 12 months visit
Daily frequency of cravings
Time frame: 0,3,6 and 12 months
Median of the intensity of the cravings
Time frame: 0, 3, and 12 months visit
Number of addictive behavioural episodes
Time frame: 0,3,6 and 12 months
Frequency of addictive behavioural episodes
Time frame: 0,3,6 and 12 months
Type of addictive behavioural episodes
Time frame: 0,3,6 and 12 months visit
Severity of addictive disorder: addictive substance disorder or pathological gambling
Time frame: 0,3,6 and 12 months
Severity of addictive disorder: Yale Food Addiction Scale (YFAS) food addiction score for bulimia nervosa
Time frame: 0 and 12 months visit
Severity of addictive disorder: sexual addiction (Carnes criteria)
Time frame: 0,3,6 and 12 months visit
Impulsivity (UPPS scale)
Time frame: 0,3,6 and 12 months
Number of strategies to deal with craving according to the type of addictive behaviour
Time frame: 0,3,6 and 12 months
Multidimensional evaluation of coping (Brief Cope scale by Muller and Spitz)
Time frame: 0,3,6 and 12 months
Anxiety: Beck's inventory for anxiety (BAI)
Time frame: 0,3,6 and 12 months
Depression: Beck's depression inventory
Time frame: 0,3,6 and 12 months
Quality of life: World Health Organization Quality of Life (WHOQOL 26 scale)
Time frame: 0,3,6 and 12 months
Self-esteem (Coopersmith inventory)
Time frame: 0,3,6 and 12 months
Use of healthcare related to addictive disorder: Hospitalisation
Time frame: 0,3,6 and 12 months
Use of healthcare related to addictive disorder: emergency department accesses
Time frame: 0,3,6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloe Lucet, PH principal investigator
Centre Hospitalier St Anne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phoenix and Journal de bord in people with Craving, run by Centre Hospitalier St Anne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Dupouy, Nurse (01.45.65.80.64 ext. +33, j.dupouy@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median craving intensity at 6 months (time frame: 6 months visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2023.