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Video Game Play to Alleviate Adolescent Anxiety

Primary Purpose

Anxiety, Anxiety Disorders and Symptoms

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Eco-Rescue
Bejelewed 3
Sponsored by
School of Health Sciences Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety focused on measuring Digital mental health, Video Games, Cognitive Training, Emotion Regulation

Eligibility Criteria

12 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 12-14 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 Exclusion Criteria: DSM diagnoses of Bipolar, Psychosis, Autism Spectrum Disorder, present or past. Neurological injury (i.e. head injury) Currently enrolled in another cognitive training intervention

Sites / Locations

  • University of Haifa
  • University of Geneva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Eco-Rescue - Attentional Control - intervention

Bejeweled 3 - Casual gaming - intervention

No-training intervention

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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

Full Information

First Posted
June 6, 2023
Last Updated
June 20, 2023
Sponsor
School of Health Sciences Geneva
Collaborators
University of Geneva, Switzerland, University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT05923944
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
School of Health Sciences Geneva
Collaborators
University of Geneva, Switzerland, University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Anxiety Disorders and Symptoms
Keywords
Digital mental health, Video Games, Cognitive Training, Emotion Regulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eco-Rescue - Attentional Control - intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Bejeweled 3 - Casual gaming - intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No-training intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eco-Rescue
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bejelewed 3
Intervention Description
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).
Primary Outcome Measure Information:
Title
Anxiety assessed through the Screen for Child Anxiety Related Emotional Disorders Child Version (SCARED-C; Birmaher et al. 1999)
Description
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.
Time Frame
Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Secondary Outcome Measure Information:
Title
Attentional Control assessed through the Useful Field of View Task (UFOV; Yung et al., 2015)
Description
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.
Time Frame
Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Title
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/)
Description
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.
Time Frame
Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Title
Attentional Control assessed through the Multiple Objects Tracking Task (MOT; Yung et al., 2015)
Description
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.
Time Frame
Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Title
Affective Control assessed through the Affective Backward Digit Span Task (ABDS; modified version of Schweizer et al. 2019)
Description
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
Time Frame
Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Other Pre-specified Outcome Measures:
Title
Emotion Regulation habits assessed through the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski et al., 2001)
Description
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.
Time Frame
Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)]
Title
Subjective Attentional Control assessed through the Attention Control Scale (ACS; Derryberry et al., 2002).
Description
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.
Time Frame
Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Title
Depressive symptoms assessed though the modified 8-item version of the Patient Health Questionnaire (PHQ-8; Kroenke et al., 2009)
Description
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.
Time Frame
Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)
Title
Sleep and Mood assessed through stand-alone questions for the duration of the training once a week.
Description
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).
Time Frame
Over the intervention period (4 weeks up to 8 weeks)
Title
Anxiety assessed with the following statement for the duration of the training once a week.
Description
"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).
Time Frame
Over the intervention period (4 weeks up to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 12-14 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 Exclusion Criteria: DSM diagnoses of Bipolar, Psychosis, Autism Spectrum Disorder, present or past. Neurological injury (i.e. head injury) Currently enrolled in another cognitive training intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naïma Gradi, PhD Student
Phone
+33 6 31 85 49 96
Email
naima.gradi@unige.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Swann Pichon, Professor
Phone
+41 22 558 66 42
Email
swann.pichon@hesge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphné Bavelier, Professor
Organizational Affiliation
University of Geneva, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Swann Pichon, Professor
Organizational Affiliation
HES - Geneva School of Health Science, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomer Shechner, Professor
Organizational Affiliation
University of Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Haifa
City
Haifa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomer Shechner, Professor
Phone
+972 545 588 522
Email
tshechner@psy.haifa.ac.il
First Name & Middle Initial & Last Name & Degree
Tomer Shechner, Professor
Facility Name
University of Geneva
City
Geneva
ZIP/Postal Code
1202
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naïma Gradi, PhD Student
Email
naima.gradi@unige.ch
First Name & Middle Initial & Last Name & Degree
Swann Pichon, Professor
Phone
+41 22 558 66 42
Email
swann.pichon@hesge.ch
First Name & Middle Initial & Last Name & Degree
Swann Pichon, Professor
First Name & Middle Initial & Last Name & Degree
Daphné Bavelier, Professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
30460424
Citation
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.
Results Reference
background
PubMed Identifier
25741746
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.
Results Reference
background
PubMed Identifier
31289755
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.
Results Reference
background
PubMed Identifier
3153671
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.
Results Reference
background
PubMed Identifier
19592761
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.
Results Reference
background
PubMed Identifier
26197075
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.
Results Reference
background
PubMed Identifier
12003445
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.
Results Reference
background
PubMed Identifier
18752852
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
9826298
Citation
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.
Results Reference
background
Links:
URL
https://neuroscape.ucsf.edu/researchers-ace/
Description
adaptation of the TOVA as implemented in the ACE-X battery

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Video Game Play to Alleviate Adolescent Anxiety

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