Recruiting
Phase 2

MindLight

Sponsor:

Queen's University

Code:

NCT02326545

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 8 - 16

Healthy Volunteers: Not accepted

Interventions

MindLight

Online CBT

Study Details

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.

Conditions

Anxiety

Study ID

NCT02326545

Start date

Dec, 2014

Status verified date

Mar, 2016

Completion date

Jun, 2016

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Elevated levels or clinical diagnosis of anxiety

Exclusion Criteria:

  • Developmental disorders or autism

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MindLight

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

active comparator: Online CBT

Online CBT program for children

Interventions

MindLight

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 CBT

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.

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) ]

Central Contacts and Locations

Central contacts

Locations

Queen's University

Recruiting

Kingston, Ontario, Canada, K7L 3N6

Contacts

More Information

Sponsor

Queen's University

Last update posted

Apr 1, 2016

Last verified

Mar, 2016

Keywords

  • Video Games
  • Child
  • Adolescent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2016-04-01.