Evaluation of a Therapeutic Education Application in the Treatment of Young People with Moderate or Problematic Screen Use

NCT06648538 | Completed DMC

• 3 other identifiers: 38RC22.02992022-A02645-3822.04601.000170
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, controlled, and randomized study evaluates the effectiveness of the Phonix Care app in regulating screen use among young people aged 11 to 25. Faced with high and often concerning levels of screen consumption among youth, this research aims to provide an innovative intervention method beyond current psychotherapeutic and pharmacological approaches, which are often limited by the risk of relapse and the difficulty in delaying the short-term rewards offered by screen activities \[1, 2, 3\]. Phonix Care is designed to encourage awareness and self-regulation of screen use, thus promoting more responsible and autonomous behavior. The primary outcome measure is based on a problematic screen use score derived from the Digital Addiction Scale. Secondary objectives include examining the effects of the app on screen consumption, physical health, mental health, and motivation towards studies, measured through a series of questionnaires and objective evaluations. The study is conducted on 138 subjects, divided into two groups: an experimental group and a control group, over a participation period of six months. Statistical analyses will include descriptive analyses, multiple linear regression, and mediation models to assess the impact of Phonix Care. The expected outcomes of this research include significant contributions to the scientific literature regarding screen use among youth, as well as advances in adolescent and young adult health and psychology. In practice, the evaluation of Phonix Care could lead to the development of an effective medical device to quantify and treat problematic screen use, offering a complementary therapy to existing methods to prevent or remedy this issue.

1. 1.Winkler A, Dörsing B, Rief W, Shen Y, Glombiewski JA. Treatment of Internet addiction: A meta-analysis. Clinical Psychology Review. 2013;33(2):317-29. https://doi.org/10.1016/j.cpr.2012.12.005
2. 2.Xu LX, Wu LL, Geng XM, Wang ZL, Guo XY, Song KR, Liu GQ, Deng LY, Zhang JT, Potenza MN. A review of psychological interventions for Internet addiction. Psychiatry Research. 2021;302: 114016. https://doi.org/10.1016/j.psychres.2021.114016
3. 3.Zajac K, Ginley MK, Chang R, Petry NM. Treatments for Internet gaming disorder and Internet addiction: A systematic review. Psychology of Addictive Behaviors. 2017;31(8):979-94. https://doi.org/10.1037/adb0000315

Conditions

Internet Addiction Disorder

Keywords

Problematic Screen Use; Digital Therapeutics; Therapeutic Education Application; Young People; Mental Health; Physical Health

Outcome Measures

Primary Outcomes (1)

• Digital Addiction Scale

  The primary outcome measure is a problematic screen usage score ranging from 25 to 125 points, calculated from an online assessment questionnaire translated into French from the Digital Addiction Scale (Hawi et al., 2019). Participants respond to 25 statements in which they are asked to select the option that best reflects their thoughts on their screen usage, with the following response options: 1 "never"; 2 "rarely"; 3 "sometimes"; 4 "often"; and 5 "always". The statements describe nine criteria related to problematic screen usage: preoccupation; tolerance; deprivation; conflicts; associated problems; deception; attraction to other activities; relapse; and mood modification. The higher the participants' total score, the more problematic their screen usage is reported. This information is collected at two measurement times: before and after the experiment. We control for the pre-experiment level, and our primary outcome measure refers to the measurement taken after the experiment.

  pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.

Secondary Outcomes (7)

• Regulation of Screen Time Consumption

  pre-intervention (T0), post-intervention (T0 + 5 months), with a completion duration of 0 minutes (data is collected passively).

• International Physical Activity Questionnaire

  pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.

• Sleep Schedules diary

  pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.

• Revised Screen for Child Anxiety Related Emotional Disorders (SCARED-R)

  pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.

• University of Laval Loneliness Scale (ULS)

  pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.

Study Arms (2)

Phonix Care experimental group

EXPERIMENTAL

The experimental arm involves modifying the functionalities of the user's digital devices (e.g., computer, smartphone, tablet, gaming console). The objective is to allow individuals access only to essential digital functionalities such as calls, alarms, work tools, camera, and unlock recreational digital functionalities only if the user engages in non-digital leisure activities (e.g., cultural, sports, family, artistic activities). The smartphone sensors validate the activities performed to earn digital time that can be spent by the user. Gradually, the user progresses a virtual animal until reaching the third stage of therapeutic education. A phoenix will evolve simultaneously with the user when they engage in non-digital recreational activities. For 5 months, all participants' cross-platform screen-usage data are monitored with fine granularity, including the frequency of app openings, schedules of opening, and names of app openings.

Device: Phonix Care

Observational group

NO INTERVENTION

For 5 months, all participants' cross-platform screen-usage data are monitored with fine granularity, including the frequency of app openings, schedules of opening, and names of app openings.

Interventions

Phonix Care DEVICE

Phonix Care consists of a 5-month digital therapeutic program that encourages the user to engage in non-digital activities through pre-defined screen rules and off-screen challenges validated by smartphone sensors.

Phonix Care experimental group

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• To have an Android-compatible smartphone.
• To be enrolled in middle school, high school, or university.
• To be between 11 and 25 years old.

You may not qualify if:

• To have a poor understanding of the French language.
• To have participated in another interventional study in the same field within the last six months.
• To undergo psychological and/or medical follow-up related to screen addiction.
• To undergo pharmacological treatment for screen addiction disorder.
• To exceed the VRB threshold of 4500 euros.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire Autonomie, Gérontologie, E-santé, Imagerie et Société (AGEIS): collaborator
• Laboratoire de Psychologie et NeuroCognition: collaborator
• University Grenoble Alps: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• Université Savoie Mont Blanc: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

PupilLab

Saint-Martin-d'Hères, 38400, France

Location

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Related Links

• Website where participants could register to the study, get additional informations, download the digital therapeutic program and fill questionnaires.
• Mildeca \[En ligne\]. Les français " addicts " à leurs écrans ? Publication des résultats du premier Baromètre MILDECA/Harris Interactive sur les usages d'écrans et les problématiques associées ; 2021
• Rapport du Haut Conseil de la santé publique \[En ligne\]. Effets de l'exposition des enfants et des jeunes aux écrans ; 2019.
• Rapport du Haut Conseil de la santé publique \[En ligne\]. Effets de l'exposition des enfants et des jeunes aux écrans (seconde partie) : de l'usage excessif à la dépendance ; 2021.
• Médiamétrie \[En ligne\]. La parentalité à l'épreuve du numérique. Observatoire de la Parentalité \& de l'Education Numérique et UNAF ; 2020.

MeSH Terms

Conditions

Internet Addiction Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Technology Addiction; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Personal Satisfaction

Study Officials

• Alexandre BELLIER, MD, PhD

  Centre d'Investigation Clinique - CHU Grenoble Alpes / Département d'Anatomie (LADAF) - Université Grenoble Alpes / Laboratoire AGEIS - Université Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: In this study, it is impossible for participants to be blinded, as they know whether or not the Phonix Care tool is configured on their screens. However, we measure our primary and secondary judgment criteria at the first measurement time, before assigning subjects to one of the two groups. At the first stage, measurements are therefore collected blind to the conditions. In addition, the data analyses are carried out blind to the groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For each participant: 15 days of pre-intervention monitoring for Control group and Experimental Group Affectation in each group: Control group: 5 months of monitoring Experimental group: 5 months of therapeutic educational app (Phonix Care) 15 days of post-intervention monitoring for Control group and Experimental Group

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: March 3, 2023
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)