Efficacy of a Smartphone App. Designed to Manage Craving & Individual Predictors of Substance Use/Addictive Behavior

ConditionAddiction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Charles Perrens, Bordeaux

About this trial

Test the Efficacy of a smartphone application designed to manage craving and individual predictors of substance use / addictive behavior among individuals with addictive disorders

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smartphone application

    Other intervention

    Ecological Momentary Assessment (EMA) : ambulatory assessment of behaviors/symptoms in real-time on smartphones

Treatment groups

274 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
4 weeks

Secondary outcomes

1

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

Time frame
At 1-month and 4-month follow-up
2

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).

Time frame
inclusion
3

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

Time frame
4 weeks
4

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

Time frame
at 1-month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.