Clinical trial NCT05923944: Video Game Play to Alleviate Adolescent Anxiety
Official title: Evaluating the Effect of Gamified Cognitive Training and of Casual Videogame Play on Anxiety in Adolescents: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Anxiety Disorders and Symptoms
Keywords: Digital mental health
Video Games
Cognitive Training
Emotion Regulation
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
name: University of Haifa
name: Swiss National Science Foundation
First posted: 2023-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Anxiety assessed through the Screen for Child Anxiety Related Emotional Disorders Child Version (SCARED-C; Birmaher et al. 1999)
timeFrame: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Secondary outcomes:
measure: Attentional Control assessed through the Useful Field of View Task (UFOV; Yung et al., 2015)
timeFrame: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
measure: 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/)
timeFrame: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
measure: Attentional Control assessed through the Multiple Objects Tracking Task (MOT; Yung et al., 2015)
timeFrame: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
measure: Affective Control assessed through the Affective Backward Digit Span Task (ABDS; modified version of Schweizer et al. 2019)
timeFrame: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Other outcomes:
measure: Emotion Regulation habits assessed through the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski et al., 2001)
timeFrame: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)]
measure: Subjective Attentional Control assessed through the Attention Control Scale (ACS; Derryberry et al., 2002).
timeFrame: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
measure: Depressive symptoms assessed though the modified 8-item version of the Patient Health Questionnaire (PHQ-8; Kroenke et al., 2009)
timeFrame: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
measure: Sleep and Mood assessed through stand-alone questions for the duration of the training once a week.
timeFrame: Over the intervention period (4 weeks up to 8 weeks)
measure: Worry assessed with the following statement for the duration of the training once a week.
timeFrame: Over the intervention period (4 weeks up to 8 weeks)
Locations:
city: Haifa
country: Israel
facility: University of Haifa
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
affiliation: University of Geneva, Switzerland
name: Daphné Bavelier, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: HES - Geneva School of Health Science, Switzerland
name: Swann Pichon, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Haifa, Israel
name: Tomer Shechner, Professor
role: PRINCIPAL_INVESTIGATOR
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