Video Game Play to Alleviate Adolescent Anxiety

Anxiety Clinical Trial

Official title:

Evaluating the Effect of Gamified Cognitive Training and of Casual Videogame Play on Anxiety in Adolescents: Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05923944
• Other study ID #: 10001C_212812
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: School of Health Sciences Geneva
• Contact: Naïma Gradi, PhD Student
• Phone: +33 6 31 85 49 96
• Email: naima.gradi[@]unige.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

Inclusion Criteria:

1. Age 12-14 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Anxiety Disorders and Symptoms

Intervention

Behavioral:
• Eco-Rescue
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.
• Bejelewed 3
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).

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa
Switzerland	University of Geneva	Geneva

Sponsors (4)

Lead Sponsor	Collaborator
School of Health Sciences Geneva	Swiss National Science Foundation, University of Geneva, Switzerland, University of Haifa

Countries where clinical trial is conducted

Israel,  Switzerland, 

References & Publications (10)

Behrens B, Swetlitz C, Pine DS, Pagliaccio D. The Screen for Child Anxiety Related Emotional Disorders (SCARED): Informant Discrepancy, Measurement Invariance, and Test-Retest Reliability. Child Psychiatry Hum Dev. 2019 Jun;50(3):473-482. doi: 10.1007/s10578-018-0854-0. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emotion Regulation habits assessed through the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski et al., 2001)	The CERQ is a 36-item self-report measure that captures stable-dispositional cognitive emotion regulation strategies when people experience stressful or threatening life experiences. Specifically, the following strategies are measured: Self-blame, blaming others, acceptance, refocusing on planning, positive refocusing, rumination, positive reappraisal, putting into perspective, and catastrophizing. Each subscale comprises 4 items and uses a 5-point scale (1 = almost never, 5 = almost always); the range of scores for each subscale is 4-20. Analysis of change will be based on the total score. A higher score represents greater use of cognitive coping strategies.	Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)]
Other	Subjective Attentional Control assessed through the Attention Control Scale (ACS; Derryberry et al., 2002).	The ACS is a 20-item self-report questionnaire designed to measure the construct of attention focusing and attention shifting. 20 items are rated on a 4-point Likert Scale from 1 (almost never) to 4 (always). Respondents rate items according to their experience in the past 4 weeks. Analysis of change will be based on the total score and on scores of each subscale. A lower score indicates higher attentional control abilities.	Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Other	Depressive symptoms assessed though the modified 8-item version of the Patient Health Questionnaire (PHQ-8; Kroenke et al., 2009)	The PHQ-8 is designed to assess symptoms of depression. Participants are asked to indicate the frequency of experiencing eight specific problems or symptoms over the course of the past four weeks. (e.g., "feeling down, depressed, or hopeless," "feeling tired or having little energy,"). Each item is rated 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day). Analysis of change will be based on the total score. A higher score indicates higher depressive symptoms.	Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Other	Sleep and Mood assessed through stand-alone questions for the duration of the training once a week.	Sleep: "During the past week, how would you rate your sleep quality overall. This question is rated from 1 (very poor) to 5 (very good).; Positive mood: "How much have you experienced positive mood in the past week?" This question is rated from 1 (not at all) to 5 (extremely).; Negative mood: "How much have you experienced negative mood in the past week?" This question is rated from 1 (not at all) to 5 (extremely).	Over the intervention period (4 weeks up to 8 weeks)
Other	Worry assessed with the following statement for the duration of the training once a week.	"During the past week I worried a lot." This item is rated 0 (not true), 1 (somewhat true), or 2 (true), and was taken from the Strengths and Difficulties Questionnaire (item 8 from the emotional problems scale, Goodman et al. 1998).	Over the intervention period (4 weeks up to 8 weeks)
Primary	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	Attentional Control assessed through the Useful Field of View Task (UFOV; Yung et al., 2015)	The UFOV is a computerized divided attention task where participants have to identify whether a briefly flashed smiley presented at the center of the screen has short or long hair and detect on which of the eight cardinal directions was a peripheral target stimulus presented, while ignoring other distractors. The presentation time is made shorter (more difficult) or longer (less difficult) according to a 3-down-1-up staircase. The task stops after 8 reversals or 72 trials, whichever happens first. Performance is measured by the mean presentation time of the last 5 trials (expressed in milliseconds). The task measures the efficiency of divided visual attention in the presence of visual distractors.	Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Secondary	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/)	The TOVA is a computerized task where participants press a response key when presented with a visual stimulus in the upper part of the screen (go trials) and refrain from responding if flashed in the lower part of the screen (no-go trials). A first block evaluates sustained attention and a second impulsivity. In the sustained attention, go trials represent 25% of the trials; in the impulsivity block, go trials represent 75% of the trials.	Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Secondary	Attentional Control assessed through the Multiple Objects Tracking Task (MOT; Yung et al., 2015)	The MOT is a computerized task in which participants are presented 16 yellow smileys moving freely within a circular area. During the first two seconds of each trial, a subset of these items is flagged as targets by being blue. Participants are instructed to track these blue smileys even though they turn back to yellow and become indistinguishable from the other items. After a few seconds, the items stop moving, one item is highlighted, and participants respond whether this item was initially flagged blue or not. MOT performance is measured as the percentage of correct responses (i.e. accuracy) in trials with 3, 4, 5 and 6 targets independently and combined overall. Higher accuracy score indicates better task performance. This task requires not only selecting targets amongst distractors but also dividing one's attention among these moving targets. Furthermore, it requires sustaining attention for a few seconds, necessitating both sustained attention and visuo-spatial working memory.	Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Secondary	Affective Control assessed through the Affective Backward Digit Span Task (ABDS; modified version of Schweizer et al. 2019)	The ABDS is a computer-based task where participants are presented with digits (for 1500 ms) one after the other, and asked to recall them in reverse order. These are presented on a background of either neutral or affective images, in two different blocks, to manipulate valence. The images are sourced from the Geneva Affective Picture Database. In each trial, participants are presented with a series of single digits [0-9]. The length of the series to recall is increased or decreased by one digit depending on previous trial performance according to a 1-up-1-down staircase. No feedback is provided. After two reversals the block stops. Span is estimated for each block as the maximum correct length recalled. The span difference between the neutral versus affective blocks is an index of the individual ability to implement control in the face of affective distraction	Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

External Links

•   adaptation of the TOVA as implemented in the ACE-X battery