NCT05923944

Brief Summary

Adolescence is a critical period for the onset and maintenance of anxiety disorders, which raises the importance of intervening early; one possibility of doing so is via digital interventions. At least two lines of research have been explored in the past years in this area. First, studies have tested the anxiolytic effects of casual video games, hypothesizing that, through the induction of flow, these games can effectively distract individuals from anxiety-related thoughts and feelings. Second, the bidirectional link between poor attentional control and higher anxiety has led to the design of novel interventions aiming to improve attentional control such as working memory training studies. Importantly, action video games, classified as a distinct gaming genre, have been shown to enhance attentional control. In this study, we aim to compare the effects of action video game play and casual game play to a no-training group, assessing their potential to alleviate anxiety when delivered entirely online. The goal of this three- arms randomized controlled trial is to evaluate the feasibility of a 6-week video game training intervention to reduce adolescent anxiety-related symptoms. We will also examine the efficacy of the proposed treatment when entirely deployed at adolescents' home.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
0mo left

Started Jun 2024

Typical duration for not_applicable anxiety

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jun 2024Jun 2026

First Submitted

Initial submission to the registry

June 6, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

June 6, 2023

Last Update Submit

May 20, 2025

Conditions

Keywords

Digital mental healthVideo GamesCognitive TrainingEmotion Regulation

Outcome Measures

Primary Outcomes (1)

  • Anxiety assessed through the Screen for Child Anxiety Related Emotional Disorders Child Version (SCARED-C; Birmaher et al. 1999)

    The SCARED-C is a 41 items self-report anxiety questionnaire with subscales measuring General Anxiety Disorder, Social Phobia Disorder, Panic Disorder, Separation Anxiety Disorder and School Avoidance. Participants are asked to rate each statement, referring to the past four weeks, on a scale ranging from 0 (Not True or Hardly Ever True) to 2 (Very True or Often True). A score of 25 or higher may indicate the presence of an Anxiety Disorder. Analysis of primary outcome will be based on this total score.

    Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

Secondary Outcomes (4)

  • Attentional Control assessed through the Useful Field of View Task (UFOV; Yung et al., 2015)

    Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

  • Attentional Control assessed through an adaptation of the Test of Variables of Attention (TOVA) as implemented in the ACE-X battery (Mars-UFO and Venus-UFO; https://neuroscape.ucsf.edu/researchers-ace/)

    Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

  • Attentional Control assessed through the Multiple Objects Tracking Task (MOT; Yung et al., 2015)

    Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

  • Affective Control assessed through the Affective Backward Digit Span Task (ABDS; modified version of Schweizer et al. 2019)

    Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

Other Outcomes (5)

  • Emotion Regulation habits assessed through the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski et al., 2001)

    Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)]

  • Subjective Attentional Control assessed through the Attention Control Scale (ACS; Derryberry et al., 2002).

    Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

  • Depressive symptoms assessed though the modified 8-item version of the Patient Health Questionnaire (PHQ-8; Kroenke et al., 2009)

    Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

  • +2 more other outcomes

Study Arms (3)

Eco-Rescue - Attentional Control - intervention

EXPERIMENTAL

The Eco-Rescue training intervention will be delivered through a dedicated video game installed on each participant's personal computer through the Steam platform, following a recommended training regimen of 30 minutes per day, 4 days per week for 6 weeks, for an expected total training duration of 12 hours.

Behavioral: Eco-Rescue

Bejeweled 3 - Casual gaming - intervention

EXPERIMENTAL

The Bejeweled 3 training intervention will be delivered through a dedicated video game installed on each participant's personal computer through the Steam platform, following a recommended training regimen of 30 minutes per day, 4 days per week for 6 weeks, for an expected total training duration of 12 hours.

Behavioral: Bejelewed 3

No-training intervention

NO INTERVENTION

The No-training intervention group does not involve any specific training program. Instead, participants assigned to this group will receive weekly phone calls, similar to the other groups, to answer the same questions as the other groups concerning their mental and emotional states and maintain regular contact throughout the 6-week study duration.

Interventions

Eco-RescueBEHAVIORAL

Ecorescue is a gamified adaptation of the multiple object tracking task (MOT) combined with a detection task. It requires to track the spatial position of specific moving targets among visually similar moving distractors, while at the same time detecting briefly flashed events. It was designed to load on attentional control and visuo-spatial working memory. Additionally, targets may express various facial emotions (happy, angry or neutral) requiring some emotional control in addition to attentional control.

Eco-Rescue - Attentional Control - intervention
Bejelewed 3BEHAVIORAL

Bejeweled 3 is a commercially available puzzle video game developed and edited by PopCap Games. The main objective is to swap two adjacent gems of seven colors to create a line or row of 3 or more gems of the same type. When these gems are aligned, they disappear, and points are earned. The goal is to get as many points as possible until it is impossible to line up gems. Bejeweled 3 offers a variety of game modes that players can freely explore at their own pace, enhancing the overall enjoyment and providing increased variability during each gaming session. These game modes typically have shorter durations, with a single game usually lasting less than 5 minutes. Bejeweled 3 was chosen as it requires fewer attentional resources compared to Eco-Rescue and because it was reported to reduce stress and anxiety in adult samples (Russoniello et al. 2009, 2013).

Bejeweled 3 - Casual gaming - intervention

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents aged 11-15 years
  • High-anxious score from the 41 items SCARED-Parent version (i.e. total score equal or above 17)
  • Access to a computer (at least Windows 7 or Mac OSX) at home and a reliable internet connection

You may not qualify if:

  • DSM diagnoses of Bipolar, Psychosis, Autism Spectrum Disorder, present or past.
  • Neurological injury (i.e. head injury)
  • Currently enrolled in another cognitive training intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Haifa

Haifa, Israel

RECRUITING

University of Geneva

Geneva, Canton of Geneva, 1202, Switzerland

RECRUITING

Related Publications (11)

  • Hisamura M, Murao M. [Studies on the changes of vital functions during upper gastrointestinal endoscopy in the aged patients (author's transl)]. Nihon Ronen Igakkai Zasshi. 1981 Nov;18(6):469-75. No abstract available. Japanese.

    PMID: 7339086BACKGROUND
  • Yung A, Cardoso-Leite P, Dale G, Bavelier D, Green CS. Methods to test visual attention online. J Vis Exp. 2015 Feb 19;(96):52470. doi: 10.3791/52470.

    PMID: 25741746BACKGROUND
  • Schweizer S, Leung JT, Kievit R, Speekenbrink M, Trender W, Hampshire A, Blakemore SJ. Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial. Wellcome Open Res. 2019 Oct 2;4:91. doi: 10.12688/wellcomeopenres.15229.2. eCollection 2019.

    PMID: 31289755BACKGROUND
  • Pylyshyn ZW, Storm RW. Tracking multiple independent targets: evidence for a parallel tracking mechanism. Spat Vis. 1988;3(3):179-97. doi: 10.1163/156856888x00122.

    PMID: 3153671BACKGROUND
  • Russoniello CV, O'Brien K, Parks JM. EEG, HRV and Psychological Correlates while Playing Bejeweled II: A Randomized Controlled Study. Stud Health Technol Inform. 2009;144:189-92.

    PMID: 19592761BACKGROUND
  • Russoniello CV, Fish M, O'Brien K. The Efficacy of Casual Videogame Play in Reducing Clinical Depression: A Randomized Controlled Study. Games Health J. 2013 Dec;2(6):341-6. doi: 10.1089/g4h.2013.0010. Epub 2013 Nov 8.

    PMID: 26197075BACKGROUND
  • Derryberry D, Reed MA. Anxiety-related attentional biases and their regulation by attentional control. J Abnorm Psychol. 2002 May;111(2):225-36. doi: 10.1037//0021-843x.111.2.225.

    PMID: 12003445BACKGROUND
  • Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.

    PMID: 18752852BACKGROUND
  • Garnefski, N., Kraaij, V., & Spinhoven, P. (2001). Negative life events, cognitive emotion regulation and emotional problems. Personality and Individual differences, 30(8), 1311-1327.

    BACKGROUND
  • Goodman R, Meltzer H, Bailey V. The Strengths and Difficulties Questionnaire: a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry. 1998 Sep;7(3):125-30. doi: 10.1007/s007870050057.

    PMID: 9826298BACKGROUND
  • Gradi N, Chopin A, Bavelier D, Shechner T, Pichon S. Evaluating the effect of action-like video game play and of casual video game play on anxiety in adolescents with elevated anxiety: protocol for a multi-center, parallel group, assessor-blind, randomized controlled trial. BMC Psychiatry. 2024 Jan 19;24(1):56. doi: 10.1186/s12888-024-05515-7.

Related Links

MeSH Terms

Conditions

Anxiety DisordersEmotional Regulation

Condition Hierarchy (Ancestors)

Mental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Daphné Bavelier, Professor

    University of Geneva, Switzerland

    PRINCIPAL INVESTIGATOR
  • Swann Pichon, Professor

    HES - Geneva School of Health Science, Switzerland

    PRINCIPAL INVESTIGATOR
  • Tomer Shechner, Professor

    University of Haifa, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naïma Gradi, PhD Student

CONTACT

Swann Pichon, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 28, 2023

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations