AnxietyPhase 2NCT02326545
MindLight: A Video Game Intervention to Reduce Children's Anxiety
A Phase 2 study testing MindLight and Online CBT in people with Anxiety, run by Queen's University at 1 site in Canada.
Trial summary
Anxiety is the most prevalent form of children's mental health problems and demand far exceeds treatment availability. Even when children do have access to care, evidence-based treatments such as cognitive-behavioural therapy have several limitations: they are largely didactic, leaving children unmotivated and… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Anxiety
- What is being tested?
- MindLight and Online CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elevated levels or clinical diagnosis of anxiety
Who cannot join
- Developmental disorders or autism
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Queen's University
Kingston, Ontario, K7L 3N6
Tom Hollenstein, PhD, 6135333288, tom.hollenstein@queensu.ca
Jessica Wilfong, BS, 613-533-2892, teenlab@gmail.com
About this study
Anxiety is the most prevalent form of children's mental health problems and demand far exceeds treatment availability. Even when children do have access to care, evidence-based treatments such as cognitive-behavioural therapy have several limitations: they are largely didactic, leaving children unmotivated and disengaged; children get little practice in using the skills they are taught, creating a large gap between their knowledge and their everyday behaviour and therapy is costly, often prohibitive for the children that most need it. Therapeutic video games can address each of these gaps: they are engaging contexts through which children practice skills (rather than memorize lessons), and they cost substantially less than conventional approaches. The proposed research will test the effectiveness of MindLight, an innovative video game that targets childhood anxiety problems. MindLight incorporates several evidence-based strategies including relaxation and exposure techniques, attention bias modification methods, and neurofeedback mechanics that together produce an immersive game world through which children learn to manage and overcome anxiety symptoms. Two randomized controlled studies with 8-16 year old children are proposed to test the effectiveness of MindLight in reducing anxiety: the first is a prevention study aimed at children at risk for developing serious anxiety problems and the second is a clinical trial aimed at decreasing symptoms in anxiety-disordered children. Children randomly assigned to the intervention group will play MindLight for 5 hours over 2-3 weeks; control participants in the prevention sample will play a commercial video game with a similar theme for the same amount of time whereas control participants in the clinical sample will use an online cognitive behavioural therapy (CBT) program. Both studies will assess children's anxiety levels before the intervention, just after, and at a 3-month follow-up. Moderators (e.g., comorbidities) and mediators (e.g., attention biases) will be assessed to identify potential mechanisms of change associated with successful intervention effects.
Read the detailed description
Over the next two years, the investigators will be collecting data on two samples, henceforth identified as the Clinical Sample and Prevention Sample. The laboratory protocol (pre, post, and follow-up) is the same for each; however the screening and recruitment are not. In this section, only those procedures and methods of the lab visit that are common to both are described. Next the video game intervention procedures are described. Participant and recruitment details are in subsequent sections.
Each participant will visit the Adolescent Dynamics Lab three times (pre, post, and follow-up) with only minor differences where noted. Parents will accompany children to the lab and, following the completion of consent forms (pre only), complete a set of questionnaires via computer:
Child report:
- Demographics
- Spence Child Anxiety Scale (SCAS)
- Strengths and Difficulties Questionnaire (SDQ)- emotional symptoms
- Top Problems questionnaire (TP)
- Coping Questionnaire
- Self-Efficacy Questionnaire (SEQ-C)
Parent report:
- Demographics (including what interventions for child's mental health have been tried)
- SCAS (report on child)
- Strengths and Difficulties Questionnaire - emotional symptoms (report on child)
- Depression, Anxiety and Stress Scale-21 (DASS21, report on self)
Questionnaires at Post are the same as Pre and Follow-up except for addition of Video game evaluation (child report).
Once questionnaires are completed, the child participant will have sensors for psychophysiological recording attached by a female experimenter. First, two sensors for recording electrodermal response (aka galvanic skin response or skin conductance) will be attached to the tips of the second and third finger of the non-dominant hand. Children's fingers will be wiped clean before applying a dab of conducting gel on the two fingers and affixing the sensors with Velcro straps firmly but not uncomfortably. Next, two sticker electrodes for measuring electrocardiogram signals (e.g., heart rate) are applied in a Lead-II configuration: one affixed just below the right collarbone and the other on the side of the torso near the lower left rib. These circular stickers (about the size of a Loonie) have a metal nub to which wires are affixed via clips. Finally, a respiration belt is wrapped around the torso below the breast or pectoral muscle outside of the clothing. The belt is elastic and registers the expansion and contraction due to respiration. All three measurement devices are attached to a Biopac TEL-100 battery pack attached to the back of the participant's chair. This device is then attached to a computer in the adjacent room via the Biopac MP-150 amplifier. Physiological signals are recorded using AcqKnowledge 4.2 software from Biopac. The child and parent will be able to observe the signals as they will be recorded via a monitor in the observation room.
Once the sensors and physiological recording has been set up, the parent will be asked to leave the room and wait in a room nearby until the child has completed the tasks. The sequence of tasks is:
- Baseline Physiology (3 tasks): (a) equipment baseline: watch a neutral film to allow the measurements to settle(2 minutes), (b) paced breathing to get resting respiratory sinus arrhythmia (RSA; a measure of parasympathetic activity) while participants breathe in and out in synch with a bar that goes up and down at 9 cycles per minute displayed on a monitor (2 minutes), and (c) pre-task baseline for calculating reactivity to social and cognitive stress (2 minutes)
- Attention bias task: dot probe task. (5 minutes)
- Social Stress Task: spontaneous speech on any topic of the child's choosing (3 minutes).
- Quick self-report of feelings (< 1 minute)
- Recovery 1: participant sits alone in the observation room quietly to assess return to baseline levels of arousal (3 minutes).
- Cognitive Stress Task: counting backwards by 7's from 2148. Incorrect answers will require the participant to start over from the beginning (2 minutes)
- Recovery 2: participant sits alone in the observation room quietly to assess return to baseline levels of arousal (3 minutes).
Finally, the parent will be brought back into the room as the sensors are removed. Debriefing will occur only after the final follow-up lab visit. Anticipated time to complete lab visit is approximately one hour.
MINDLIGHT GAME PLAY Participants in the treatment condition will play 5 total hours of MindLight, one hour at each sitting, over the course of 2-3 weeks. Game play will occur either in schools or at the participant's home. For the Prevention Sample, MindLight will be played in participating middle and high schools in the Limestone District School Board. Participants in the Clinical Sample who attend these schools will also play the game at the school. However, for children recruited through the Hotel Dieu Mood and Anxiety clinic (see recruitment details) who do not attend one of the participating schools will play MindLight at home. In all cases, a research assistant will be present to set up the game and monitor any equipment difficulties.
To play the game, children will wear a lightweight MindWave headset that has a single electrode that must touch the forehead (see attached images). There is a clip that attaches comfortably to the earlobe as well. The electroencephalogram (EEG) signals in the alpha, beta, and gamma frequencies are used to extract two continuous signal streams that are measures of focused attention and arousal. These signals are used in the game to control the character's "mind light," a magical hat he wears that has a light on the end of a signal antenna, by focusing a beam of light toward specific targets to solve puzzles within the game and expanding the range of light inversely proportional to the degree of arousal. Thus, children control key aspects of the game with their mind.
Control participants in the Prevention Sample will play Max and the Magic Marker, a commercially available game with similar features to MindLight but without the key mechanisms targeting anxiety reduction (attention bias modification and relaxation). The amount of game play time and location will be the same as those in the intervention group.
ONLINE COGNITIVE BEHAVIOURAL THERAPY Control participants in the Clinical Sample will receive an online version of cognitive behavioural therapy (CBT) based on the skills taught in Mind over Mood by D. Greenberger and C. Padesky. The program provides general information on each topic, an overview on helpful skills, and homework sheets by email that directly corresponds with how a live, 8-week group therapy session would be conducted. Participants will also receive feedback on homework on a specific day every week from a therapist at Hotel Dieu.
Description of participants CLINICAL SAMPLE Children 8-16 years old who have made an appointment at the Mood and Anxiety Clinic at Hotel Dieu specifically for problems with anxiety. Only those with autism or significant developmental delays will be excluded. The investigators will recruit 100 children, with half randomly assigned to the MindLight intervention group.
PREVENTION SAMPLE Children 10-16 years old attending participating schools in the Limestone District School Board who have been identified as having elevated anxiety symptoms via a self-report measure of anxiety. Only those with autism or significant developmental delays will be excluded. The investigators will recruit 100 children, with half randomly assigned to the MindLight intervention group.
Recruitment details CLINICAL SAMPLE Participants will be recruited following initial assessment at the Hotel Dieu Mood and Anxiety Clinic. The typical wait period between this initial diagnostic assessment and the start of either group or one-on-one therapy is 3-6 months. Our intervention will occur during this wait period. During the initial assessment at the clinic, children aged 8-16 will be invited to participate in the study. They will be provided a brief explanation of the study and will indicate to the clinician whether they give permission to be contacted by the recruitment coordinator who will provide all of the details of the study. The participant will be made aware that they are under no obligation to participate in the study by agreeing to be contacted. Those who assent to participate will be invited to the Adolescent Dynamics Lab to begin participation.
PREVENTION SAMPLE Children in grades 6-10 who attend one of the participating schools will complete one questionnaire during class time, the Spence Children's Anxiety Scale (SCAS). Children who score 1 standard deviation above the mean for (a) the total score or (b) two of the subscales (not including the obsessive-compulsive scale) will be considered at risk for developing an anxiety disorder. These children will be invited to participate in the study by visiting the Adolescent Dynamics Lab. Consent for the study will be obtained from the parent prior to the SCAS screening.
- Conditions
- Anxiety
- Being tested
- MindLight, Online CBT
- Keywords
- Video Games, Child, Adolescent
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindLightBehavioural
MindLight is a video game that uses neurofeedback as part of game mechanics. Participants play for 5 hours total over 3 weeks. Measures taken pre, post, and 3-month follow-up.
Online CBTBehavioural
Also called Cognitive Behavioral Therapy
Five sessions of power point slides that cover primary concepts and homework of cognitive behavioral therapy. Adapted for children. Measures taken pre, post, and 3-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| MindLight | Experimental | MindLight is the video game being tested for effectiveness to reduce child anxiety Receives: Behavioral: MindLight |
| Online CBT | Active comparator | Online CBT program for children Receives: Behavioral: Online CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spence Children's Anxiety Scale following intervention
Widely used scale for measuring children's anxiety will be used to determine the degree of reduction in anxiety symptoms immediately following the intervention and whether this reduction is maintained at a 3-month follow-up.
Measured: Pre-Tx (1st lab visit), Post-Tx (2nd lab visit 3 weeks later), Follow-up (final lab visit 3 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Responsible party
- Principal investigator, Dr. Tom Hollenstein, Queen's University
- Investigators
- Tom Hollenstein, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326545
- Sponsor's protocol ID
- MindLight
- Status last verified
- Mar 2016
- First submitted
- 15 Dec 2014
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be shared
Publications
Tsui TYL, DeFrance K, Khalid-Khan S, Granic I, Hollenstein T. Reductions of Anxiety Symptoms, State Anxiety, and Anxious Arousal in Youth Playing the Videogame MindLight Compared to Online Cognitive Behavioral Therapy. Games Health J. 2021 Oct;10(5):330-338. doi: 10.1089/g4h.2020.0083. Epub 2021 Aug 17.
PubMed 34403591
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MindLight: A Video Game Intervention to Reduce Children's Anxiety
- ClinicalTrials.gov ID
- NCT02326545
- Acronym / sponsor ID
- MindLight
- Conditions
- Anxiety
- Keywords
- Video Games, Child, Adolescent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety is the most prevalent form of children's mental health problems and demand far exceeds treatment availability. Even when children do have access to care, evidence-based treatments such as cognitive-behavioural therapy have several limitations: they are largely didactic, leaving children unmotivated and disengaged; children get little practice in using the skills they are taught, creating a large gap between their knowledge and their everyday behaviour and therapy is costly, often prohibitive for the children that most need it. Therapeutic video games can address each of these gaps: they are engaging contexts through which children practice skills (rather than memorize lessons), and they cost substantially less than conventional approaches. The proposed research will test the effectiveness of MindLight, an innovative video game that targets childhood anxiety problems. MindLight incorporates several evidence-based strategies including relaxation and exposure techniques, attention bias modification methods, and neurofeedback mechanics that together produce an immersive game world through which children learn to manage and overcome anxiety symptoms. Two randomized controlled studies with 8-16 year old children are proposed to test the effectiveness of MindLight in reducing anxiety: the first is a prevention study aimed at children at risk for developing serious anxiety problems and the second is a clinical trial aimed at decreasing symptoms in anxiety-disordered children. Children randomly assigned to the intervention group will play MindLight for 5 hours over 2-3 weeks; control participants in the prevention sample will play a commercial video game with a similar theme for the same amount of time whereas control participants in the clinical sample will use an online cognitive behavioural therapy (CBT) program. Both studies will assess children's anxiety levels before the intervention, just after, and at a 3-month follow-up. Moderators (e.g., comorbidities) and mediators (e.g., attention biases) will be assessed to identify potential mechanisms of change associated with successful intervention effects.
Detailed description
Over the next two years, the investigators will be collecting data on two samples, henceforth identified as the Clinical Sample and Prevention Sample. The laboratory protocol (pre, post, and follow-up) is the same for each; however the screening and recruitment are not. In this section, only those procedures and methods of the lab visit that are common to both are described. Next the video game intervention procedures are described. Participant and recruitment details are in subsequent sections.
Each participant will visit the Adolescent Dynamics Lab three times (pre, post, and follow-up) with only minor differences where noted. Parents will accompany children to the lab and, following the completion of consent forms (pre only), complete a set of questionnaires via computer:
Child report:
- Demographics
- Spence Child Anxiety Scale (SCAS)
- Strengths and Difficulties Questionnaire (SDQ)- emotional symptoms
- Top Problems questionnaire (TP)
- Coping Questionnaire
- Self-Efficacy Questionnaire (SEQ-C)
Parent report:
- Demographics (including what interventions for child's mental health have been tried)
- SCAS (report on child)
- Strengths and Difficulties Questionnaire - emotional symptoms (report on child)
- Depression, Anxiety and Stress Scale-21 (DASS21, report on self)
Questionnaires at Post are the same as Pre and Follow-up except for addition of Video game evaluation (child report).
Once questionnaires are completed, the child participant will have sensors for psychophysiological recording attached by a female experimenter. First, two sensors for recording electrodermal response (aka galvanic skin response or skin conductance) will be attached to the tips of the second and third finger of the non-dominant hand. Children's fingers will be wiped clean before applying a dab of conducting gel on the two fingers and affixing the sensors with Velcro straps firmly but not uncomfortably. Next, two sticker electrodes for measuring electrocardiogram signals (e.g., heart rate) are applied in a Lead-II configuration: one affixed just below the right collarbone and the other on the side of the torso near the lower left rib. These circular stickers (about the size of a Loonie) have a metal nub to which wires are affixed via clips. Finally, a respiration belt is wrapped around the torso below the breast or pectoral muscle outside of the clothing. The belt is elastic and registers the expansion and contraction due to respiration. All three measurement devices are attached to a Biopac TEL-100 battery pack attached to the back of the participant's chair. This device is then attached to a computer in the adjacent room via the Biopac MP-150 amplifier. Physiological signals are recorded using AcqKnowledge 4.2 software from Biopac. The child and parent will be able to observe the signals as they will be recorded via a monitor in the observation room.
Once the sensors and physiological recording has been set up, the parent will be asked to leave the room and wait in a room nearby until the child has completed the tasks. The sequence of tasks is:
- Baseline Physiology (3 tasks): (a) equipment baseline: watch a neutral film to allow the measurements to settle(2 minutes), (b) paced breathing to get resting respiratory sinus arrhythmia (RSA; a measure of parasympathetic activity) while participants breathe in and out in synch with a bar that goes up and down at 9 cycles per minute displayed on a monitor (2 minutes), and (c) pre-task baseline for calculating reactivity to social and cognitive stress (2 minutes)
- Attention bias task: dot probe task. (5 minutes)
- Social Stress Task: spontaneous speech on any topic of the child's choosing (3 minutes).
- Quick self-report of feelings (< 1 minute)
- Recovery 1: participant sits alone in the observation room quietly to assess return to baseline levels of arousal (3 minutes).
- Cognitive Stress Task: counting backwards by 7's from 2148. Incorrect answers will require the participant to start over from the beginning (2 minutes)
- Recovery 2: participant sits alone in the observation room quietly to assess return to baseline levels of arousal (3 minutes).
Finally, the parent will be brought back into the room as the sensors are removed. Debriefing will occur only after the final follow-up lab visit. Anticipated time to complete lab visit is approximately one hour.
MINDLIGHT GAME PLAY Participants in the treatment condition will play 5 total hours of MindLight, one hour at each sitting, over the course of 2-3 weeks. Game play will occur either in schools or at the participant's home. For the Prevention Sample, MindLight will be played in participating middle and high schools in the Limestone District School Board. Participants in the Clinical Sample who attend these schools will also play the game at the school. However, for children recruited through the Hotel Dieu Mood and Anxiety clinic (see recruitment details) who do not attend one of the participating schools will play MindLight at home. In all cases, a research assistant will be present to set up the game and monitor any equipment difficulties.
To play the game, children will wear a lightweight MindWave headset that has a single electrode that must touch the forehead (see attached images). There is a clip that attaches comfortably to the earlobe as well. The electroencephalogram (EEG) signals in the alpha, beta, and gamma frequencies are used to extract two continuous signal streams that are measures of focused attention and arousal. These signals are used in the game to control the character's "mind light," a magical hat he wears that has a light on the end of a signal antenna, by focusing a beam of light toward specific targets to solve puzzles within the game and expanding the range of light inversely proportional to the degree of arousal. Thus, children control key aspects of the game with their mind.
Control participants in the Prevention Sample will play Max and the Magic Marker, a commercially available game with similar features to MindLight but without the key mechanisms targeting anxiety reduction (attention bias modification and relaxation). The amount of game play time and location will be the same as those in the intervention group.
ONLINE COGNITIVE BEHAVIOURAL THERAPY Control participants in the Clinical Sample will receive an online version of cognitive behavioural therapy (CBT) based on the skills taught in Mind over Mood by D. Greenberger and C. Padesky. The program provides general information on each topic, an overview on helpful skills, and homework sheets by email that directly corresponds with how a live, 8-week group therapy session would be conducted. Participants will also receive feedback on homework on a specific day every week from a therapist at Hotel Dieu.
Description of participants CLINICAL SAMPLE Children 8-16 years old who have made an appointment at the Mood and Anxiety Clinic at Hotel Dieu specifically for problems with anxiety. Only those with autism or significant developmental delays will be excluded. The investigators will recruit 100 children, with half randomly assigned to the MindLight intervention group.
PREVENTION SAMPLE Children 10-16 years old attending participating schools in the Limestone District School Board who have been identified as having elevated anxiety symptoms via a self-report measure of anxiety. Only those with autism or significant developmental delays will be excluded. The investigators will recruit 100 children, with half randomly assigned to the MindLight intervention group.
Recruitment details CLINICAL SAMPLE Participants will be recruited following initial assessment at the Hotel Dieu Mood and Anxiety Clinic. The typical wait period between this initial diagnostic assessment and the start of either group or one-on-one therapy is 3-6 months. Our intervention will occur during this wait period. During the initial assessment at the clinic, children aged 8-16 will be invited to participate in the study. They will be provided a brief explanation of the study and will indicate to the clinician whether they give permission to be contacted by the recruitment coordinator who will provide all of the details of the study. The participant will be made aware that they are under no obligation to participate in the study by agreeing to be contacted. Those who assent to participate will be invited to the Adolescent Dynamics Lab to begin participation.
PREVENTION SAMPLE Children in grades 6-10 who attend one of the participating schools will complete one questionnaire during class time, the Spence Children's Anxiety Scale (SCAS). Children who score 1 standard deviation above the mean for (a) the total score or (b) two of the subscales (not including the obsessive-compulsive scale) will be considered at risk for developing an anxiety disorder. These children will be invited to participate in the study by visiting the Adolescent Dynamics Lab. Consent for the study will be obtained from the parent prior to the SCAS screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MindLight | Experimental | Behavioral: MindLightMindLight is the video game being tested for effectiveness to reduce child anxiety |
| Online CBT | Active comparator | Behavioral: Online CBTOnline CBT program for children |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Elevated levels or clinical diagnosis of anxiety
Key exclusion criteria (1 listed)
- Developmental disorders or autism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindLightMindLight is a video game that uses neurofeedback as part of game mechanics. Participants play for 5 hours total over 3 weeks. Measures taken pre, post, and 3-month follow-up. | Behavioural | MindLight |
| Online CBTAlso: Cognitive Behavioral TherapyFive sessions of power point slides that cover primary concepts and homework of cognitive behavioral therapy. Adapted for children. Measures taken pre, post, and 3-month follow-up. | Behavioural | Online CBT |
Primary outcome
Change in Spence Children's Anxiety Scale following intervention
Time frame: Pre-Tx (1st lab visit), Post-Tx (2nd lab visit 3 weeks later), Follow-up (final lab visit 3 months later)
Widely used scale for measuring children's anxiety will be used to determine the degree of reduction in anxiety symptoms immediately following the intervention and whether this reduction is maintained at a 3-month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Derived from this study: PubMed 34403591Tsui TYL, DeFrance K, Khalid-Khan S, Granic I, Hollenstein T. Reductions of Anxiety Symptoms, State Anxiety, and Anxious Arousal in Youth Playing the Videogame MindLight Compared to Online Cognitive Behavioral Therapy. Games Health J. 2021 Oct;10(5):330-338. doi: 10.1089/g4h.2020.0083. Epub 2021 Aug 17.
- Individual participant dataSharing planned: Yes. Data will be shared
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Hollenstein, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MindLight and Online CBT in people with Anxiety, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Hollenstein, PhD (6135333288, Tom.Hollenstein@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spence Children's Anxiety Scale following intervention (time frame: Pre-Tx (1st lab visit), Post-Tx (2nd lab visit 3 weeks later), Follow-up (final lab visit 3 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016.