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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Stephane Geyssens, Ing contact

01.45.65.61.40

s.geysens@ghu-paris.fr

France2 sites, 2 recruiting
  • Hospices Civiles de Lyon

    Lyon

    Clara SICARD, Nurse

    Recruiting
  • CHU de Nantes

    Nantes

    Julie Caillion, Nurse

    Recruiting

Other trials in France

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 groups in NCT06140472
Study groupRoleWhat they receive
Phoenix applicationActive comparatorSpecific individualized nurse follow-up using the PHOENIX application.
Receives: Behavioral: Phoenix
Journal de bordSham comparatorRegular 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

    1. I feel sad.
    2. I am sad all the time, and I cannot snap out of it.
    3. 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

  15. 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

  16. 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

  17. Use of healthcare related to addictive disorder: Hospitalisation

    Number of hospitalization days related to addiction

    Measured: 0,3,6 and 12 months

  18. 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.

  1. First posted20 Nov 2023
  2. Study start11 Dec 2019
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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)
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

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.

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