NCT02326545

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 anxiety

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

December 15, 2014

Last Update Submit

March 30, 2016

Conditions

Keywords

Video GamesChildAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-Tx (1st lab visit), Post-Tx (2nd lab visit 3 weeks later), Follow-up (final lab visit 3 months later)

Study Arms (2)

MindLight

EXPERIMENTAL

MindLight is the video game being tested for effectiveness to reduce child anxiety

Behavioral: MindLight

Online CBT

ACTIVE COMPARATOR

Online CBT program for children

Behavioral: Online CBT

Interventions

MindLightBEHAVIORAL

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.

MindLight
Online CBTBEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy
Online CBT

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Elevated levels or clinical diagnosis of anxiety

You may not qualify if:

  • Developmental disorders or autism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tom Hollenstein, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Hollenstein, PhD

CONTACT

Jessica Wilfong, BS

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 29, 2014

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

April 1, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Data will be shared

Locations