Back to resultsEfficacy of a Smartphone App. Designed to Manage Craving & Individual Predictors of Substance Use/Addictive Behavior (CRAVINGMANAGER)
Primary Purpose
Addiction
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Smartphone application
Sponsored by
About this trial
This is an interventional other trial for Addiction focused on measuring craving
Eligibility Criteria
Inclusion Criteria:
- Participants requesting help for substance or behavioral addiction in one of the participating specialized addiction treatment centers, and with more than 1-month-delay before treatment admission
- Age >= 18 years of age
- With at least one substance or behavioral addiction (DSM-5 criteria)
- Affiliated person or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant and the investigator
Exclusion Criteria:
- Medical, psychiatric or addiction condition that warrants immediate treatment intervention
- Patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy....)
- Difficulty in understanding and / or writing French
- Not familiar with the use of smartphone
- Individuals participating in another study that includes an ongoing exclusion period
- Be deprived of liberty due to an ongoing legal procedure
- Individuals under legal protection
- Be under guardianship or under curatorship
Sites / Locations
- Centre Hospitalier Charles PERRENSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
control group
Arm Description
participants will receive and use during 4 weeks the full interventional version of the smartphone application (combining EMA + EMI) targeting craving and personal situations at risk for use
: participants will receive and use a restricted version of the smartphone application (only EMA: 4 electronic questionnaires per day to assess main problematic substance use / addictive behavior) during 4 weeks
Outcomes
Primary Outcome Measures
The decrease of main problematic substance use / addictive behavior
We will compare the percentage of participants for whom a 20% decrease in main problematic substance use / addictive behavior was observed between 1st week and 4 th week of smartphone application use in the experimental group versus the control group
Secondary Outcome Measures
Efficacy of the intervention in reduction on addiction severity (ASI) and craving for primary addiction,
Multifactorial addiction severity ASI "Composite Score" for the main problematic addiction (drug or alcohol or tobacco or behavioral addiction) : Range 0-1 (1: higher severity) and craving self-reported in the last EMA week, and reported in the Craving evaluation scale developed by the University of Bordeaux Addiction Team of the Sanpsy Laboratory will be used. It is an heteroevaluation of craving for all substances and addictive behaviors reported by the subject. This tool explores the frequency of craving, corresponding to the number of days craving was reported during the last 30 days, as well as mean and maximum intensity on a scale ranging from 0 (no craving) to 10 (extreme craving).
Comparison between baseline, 1-month et 4-month follow-ups of frequency, mean and maximum intensity of craving for main problematic addiction
Factors associated with application efficacy among initial addiction severity (ASI), initial craving for primary addiction, type of primary addiction, comorbid psychiatric disorders (MINI), and addiction treatment (ASI and TSR)
Evaluation of the initial severity of addiction ASI "Composite Score" for the main problematic addiction (drug or alcohol or tobacco or behavioral addiction) : Range 0-1 (1: higher severity), initial craving frequency and intensity with craving evaluation scale, the type of addiction,comorbid psychiatric disorders (evaluated with Mini International Neuropsychiatric Interview), and past or concomitant addiction treatment (evaluated by ASI and Treatment Service Review).
Temporal evolution of craving and substance use/addictive behaviors The evolution and temporal trajectories of craving intensity, substances use/addictive behaviors measured with EMA in daily life
During the 4 weeks use of the application, all participants will be instructed to complete 4 daily EMA electronic interviews to assess craving-and substance use/addictive behavior (see Serre, Fatseas et al. 2012). At each electronic interview, participants will be asked to rate the maximum level of craving (i.e. the desire to use the main substance/addictive behavior) that they felt since the previous assessment on a seven-point scale (1 no desire to 7 extreme desire), and will also be asked if they had used, since the previous assessment, the main substance/addictive(yes/no)
- The evolution and temporal trajectories of substances use/addictive behaviors measured with EMA in daily life
Feasibility of the smartphone application as assessed by use of the app (EMA responses) and drop-out rates
Feasibility will be assessed at the 1-month follow-up by number of days and frequency of use of the application (calculated from EMA responses: number of questionnaires answered on total number of questionnaires proposed by the application), rate of participants not completing the study, and reasons for stopping
Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS
Acceptability will be assessed at 1-month follow-up with AES, D-WAI and uMARS. The Acceptability E-scale (AES) is a 6-item questionnaire that evaluates the extent to which subjects find E-health systems acceptable. Each item is ranked on a 5-point Likert scale, generating a total score of acceptability ranging from 6 (lowest acceptability) to 30 (highest acceptability) (Micoulaud-Franchi, Sauteraud et al. 2016). The Digital Working Alliance Inventory (D-WAI) measures factors (goals, tasks and bond) to examine the therapeutic relationship between the participant and the app (Henson et al., 2019). The user version of the Mobile Application Rating Scale (uMARS) is a simple tool that can be reliably used by end-users to assess the quality of mHealth apps (Stoyanov et al., 2016).
Impact on subsequent standard treatment at 4-month follow -up
Impact of the 4 weeks use of the smartphone application Potential impact (positive or negative) of the 4 weeks use of the smartphone application on subsequent treatment will be assessed at 4-month follow-up with rate of first-time attendance to the standard treatment, time to first-time attendance to the standard treatment, compliance with standard treatment (Treatment Service Review), and evolution of severity of addiction during the standard treatment (ASI Composite Score). Follow-ups measures will be compared to baseline measures, and the difference will be compared between the two groups.
Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS
Intervention Satisfaction will be assessed at 1-month follow-up with the Client Satisfaction Questionnaire (CSQ-8), that is a multi-item measure of satisfaction related to healthcare (Larsen et al., 1979; Kapp et al., 2014). The CSQ-8 total score ranges from 8 to 32. A higher score represents greater satisfaction
Full Information
NCT ID
NCT04732676
First Posted
May 10, 2019
Last Updated
June 19, 2023
Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04732676
Brief Title
Efficacy of a Smartphone App. Designed to Manage Craving & Individual Predictors of Substance Use/Addictive Behavior
Acronym
CRAVINGMANAGER
Official Title
Efficacy of a Smartphone App Designed to Manage Craving and Individual Predictors of Substance Use / Addictive Behavior Among Individuals With Addictive Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Test the Efficacy of a smartphone application designed to manage craving and individual predictors of substance use / addictive behavior among individuals with addictive disorders
Detailed Description
This translational project is the clinical application of research results from the University of Bordeaux, Sanpsy Lab, CNRS USR3413 - on individual predictors of substance use. This project will test the efficacy of a smartphone application to help subjects concerned about reducing or stopping their substance use / behavioral addiction. This new therapeutic tool, designed by University of Bordeaux, Sanpsy Lab, CNRS USR3413 - to manage craving and individual predictors of use, will offer the possibility of an easy to-use and personalized intervention accessible to the greatest number of subjects. Based on our previous results that supports that, for all types of addiction, craving and individual cues are a significant drive for use in people with addiction, the application tested in this study was designed to be used among people presenting various types of addiction (substance and behavioral addictions). The application will also evaluate all concurrent substance uses and addictive behaviors to identify and prevent risk of addiction transfers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
craving
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized controlled trial comparing two parallel groups. This is a comparative study of superiority that evaluates the efficacy of using an interventional smartphone application,in reducing main problematic substance use/addictive behavior after 4 weeks, and after 4 months among participants requesting treatment for substance or behavioral addiction.
Masking
ParticipantCare ProviderInvestigator
Masking Description
After randomization, the application will be installed on participant's smartphone (or smartphone loaned for the study).
Randomization code will unlock one of the 2 versions of the application:
Restricted version (only EMA) for control group
Full interventional (active) version (EMA + EMI) for experimental group
Allocation
Randomized
Enrollment
274 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
participants will receive and use during 4 weeks the full interventional version of the smartphone application (combining EMA + EMI) targeting craving and personal situations at risk for use
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
: participants will receive and use a restricted version of the smartphone application (only EMA: 4 electronic questionnaires per day to assess main problematic substance use / addictive behavior) during 4 weeks
Intervention Type
Other
Intervention Name(s)
Smartphone application
Intervention Description
Ecological Momentary Assessment (EMA)
: ambulatory assessment of behaviors/symptoms in real-time on smartphones
Primary Outcome Measure Information:
Title
The decrease of main problematic substance use / addictive behavior
Description
We will compare the percentage of participants for whom a 20% decrease in main problematic substance use / addictive behavior was observed between 1st week and 4 th week of smartphone application use in the experimental group versus the control group
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Efficacy of the intervention in reduction on addiction severity (ASI) and craving for primary addiction,
Description
Multifactorial addiction severity ASI "Composite Score" for the main problematic addiction (drug or alcohol or tobacco or behavioral addiction) : Range 0-1 (1: higher severity) and craving self-reported in the last EMA week, and reported in the Craving evaluation scale developed by the University of Bordeaux Addiction Team of the Sanpsy Laboratory will be used. It is an heteroevaluation of craving for all substances and addictive behaviors reported by the subject. This tool explores the frequency of craving, corresponding to the number of days craving was reported during the last 30 days, as well as mean and maximum intensity on a scale ranging from 0 (no craving) to 10 (extreme craving).
Comparison between baseline, 1-month et 4-month follow-ups of frequency, mean and maximum intensity of craving for main problematic addiction
Time Frame
At 1-month and 4-month follow-up
Title
Factors associated with application efficacy among initial addiction severity (ASI), initial craving for primary addiction, type of primary addiction, comorbid psychiatric disorders (MINI), and addiction treatment (ASI and TSR)
Description
Evaluation of the initial severity of addiction ASI "Composite Score" for the main problematic addiction (drug or alcohol or tobacco or behavioral addiction) : Range 0-1 (1: higher severity), initial craving frequency and intensity with craving evaluation scale, the type of addiction,comorbid psychiatric disorders (evaluated with Mini International Neuropsychiatric Interview), and past or concomitant addiction treatment (evaluated by ASI and Treatment Service Review).
Time Frame
inclusion
Title
Temporal evolution of craving and substance use/addictive behaviors The evolution and temporal trajectories of craving intensity, substances use/addictive behaviors measured with EMA in daily life
Description
During the 4 weeks use of the application, all participants will be instructed to complete 4 daily EMA electronic interviews to assess craving-and substance use/addictive behavior (see Serre, Fatseas et al. 2012). At each electronic interview, participants will be asked to rate the maximum level of craving (i.e. the desire to use the main substance/addictive behavior) that they felt since the previous assessment on a seven-point scale (1 no desire to 7 extreme desire), and will also be asked if they had used, since the previous assessment, the main substance/addictive(yes/no)
- The evolution and temporal trajectories of substances use/addictive behaviors measured with EMA in daily life
Time Frame
4 weeks
Title
Feasibility of the smartphone application as assessed by use of the app (EMA responses) and drop-out rates
Description
Feasibility will be assessed at the 1-month follow-up by number of days and frequency of use of the application (calculated from EMA responses: number of questionnaires answered on total number of questionnaires proposed by the application), rate of participants not completing the study, and reasons for stopping
Time Frame
at 1-month
Title
Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS
Description
Acceptability will be assessed at 1-month follow-up with AES, D-WAI and uMARS. The Acceptability E-scale (AES) is a 6-item questionnaire that evaluates the extent to which subjects find E-health systems acceptable. Each item is ranked on a 5-point Likert scale, generating a total score of acceptability ranging from 6 (lowest acceptability) to 30 (highest acceptability) (Micoulaud-Franchi, Sauteraud et al. 2016). The Digital Working Alliance Inventory (D-WAI) measures factors (goals, tasks and bond) to examine the therapeutic relationship between the participant and the app (Henson et al., 2019). The user version of the Mobile Application Rating Scale (uMARS) is a simple tool that can be reliably used by end-users to assess the quality of mHealth apps (Stoyanov et al., 2016).
Time Frame
at 1-month
Title
Impact on subsequent standard treatment at 4-month follow -up
Description
Impact of the 4 weeks use of the smartphone application Potential impact (positive or negative) of the 4 weeks use of the smartphone application on subsequent treatment will be assessed at 4-month follow-up with rate of first-time attendance to the standard treatment, time to first-time attendance to the standard treatment, compliance with standard treatment (Treatment Service Review), and evolution of severity of addiction during the standard treatment (ASI Composite Score). Follow-ups measures will be compared to baseline measures, and the difference will be compared between the two groups.
Time Frame
at 4-month follow-up
Title
Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS
Description
Intervention Satisfaction will be assessed at 1-month follow-up with the Client Satisfaction Questionnaire (CSQ-8), that is a multi-item measure of satisfaction related to healthcare (Larsen et al., 1979; Kapp et al., 2014). The CSQ-8 total score ranges from 8 to 32. A higher score represents greater satisfaction
Time Frame
at 1-mont
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants requesting help for substance or behavioral addiction in one of the participating specialized addiction treatment centers, and with more than 1-month-delay before treatment admission
Age >= 18 years of age
With at least one substance or behavioral addiction (DSM-5 criteria)
Affiliated person or beneficiary of a social security scheme.
Free, informed and written consent signed by the participant and the investigator
Exclusion Criteria:
Medical, psychiatric or addiction condition that warrants immediate treatment intervention
Patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy....)
Difficulty in understanding and / or writing French
Not familiar with the use of smartphone
Individuals participating in another study that includes an ongoing exclusion period
Be deprived of liberty due to an ongoing legal procedure
Individuals under legal protection
Be under guardianship or under curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARC AURIACOMBE, MD, Prof
Phone
05 56 56 17 38
Email
mauriacombe@ch-perrens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
AURELIEN VAUTARD
Phone
05 56 56 34 00
Email
avautard@ch-perrens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARC AURIACOMBE, MD, Prof
Organizational Affiliation
Centre Hospitalier CHARLES PERRENS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Charles PERRENS
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARC AURIACOMBE, MD, Prof
Phone
05 56 56 17 38
Email
mauriacombe@ch-perrens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of a Smartphone App. Designed to Manage Craving & Individual Predictors of Substance Use/Addictive Behavior
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