Mightier Video Games for Emotional Dysregulation

Overseen By Jason Kahn, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Neuromotion Labs

Disqualifiers: Low IQ, Limited verbal capacity, Recent medication change, Suicidal ideation, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Access to effective pediatric mental health treatment is a major public health concern in the United States as paucity of pediatric providers leading to long wait times, financial burden, and stigma pose significant barriers to treatment. Digital mental health promises to remedy many chronic problems faced in providing timely and accessible mental health interventions to children. With that in mind, the investigators and Neuromotion Inc. created Mightier, an app-based heart rate biofeedback videogame platform designed to teach and facilitate practice of emotional regulation skills. The technology behind Mightier is backed by three trials showing clinical efficacy and since commercial launch 75% of families who have engaged with the product report improvement. However, Neuromotion's core mission remains increasing access to care, and the direct-to-consumer distribution of digital health also faces access challenges. The investigators propose that access to effective digital mental health interventions can be increased by meeting families where they already know to seek care: the traditional healthcare system. The investigators have partnered with a nationwide behavioral health insurance provider to pilot the integration of Mightier with traditional healthcare. Families will be recruited via direct outreach, social media, or healthcare provider referral. Participating children will be randomized into Mightier or treatment as usual control groups for 6 months. Behavioral healthcare utilization will be observed for 12 months. Through this work the investigators will demonstrate the value of Mightier to various stakeholders via decreased long-term healthcare utilization, confirm that Mightier use results in decreased symptoms of emotional dysregulation, irritability, and parent stress, and explore relationships among Mightier use, healthcare utilization, and symptoms. Ultimately this work will pave the way forward for large scale integration of digital healthcare and more traditional healthcare avenues while simultaneously increasing Mightier's ability to reach children in need.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have changed your medication or dosage in the past month or plan to change it in the next month.

What data supports the effectiveness of the Mightier video games treatment for emotional dysregulation?

Research shows that biofeedback-based video games like Mightier can help children improve their emotional regulation skills. In a study, children who played Mightier showed better emotional control and reduced stress for their caregivers compared to those who did not play the game. ^{1 2 3 4 5}

Is the Mightier video game platform safe for use in humans?

The available research on digital game interventions, including those for emotional regulation and mental health, generally supports their potential for safe use in humans. However, specific safety data for the Mightier video game platform is not directly addressed in the studies reviewed. ^{1 4 6 7 8}

How is the Mightier video game treatment different from other treatments for emotional dysregulation?

Mightier video games are unique because they use heart rate biofeedback to help children practice emotional regulation skills while playing, making it an engaging and interactive way to learn emotional control. Unlike traditional therapies, this approach integrates emotional learning into a fun gaming experience, which can be more appealing and accessible for children. ^{1 3 8 9 10}

Eligibility Criteria

This trial is for children aged 8-12 with emotional dysregulation issues like ADHD or ASD, who have made a behavioral health claim in the past year. They must be fluent in English, have Wi-Fi and a computer or tablet at home. It's not for kids with severe verbal limitations, recent medication changes, psychosis, mania, substance abuse issues, or those highly sensitive to wearing heart rate monitors.

Inclusion Criteria

My insurance is through Magellan Healthcare or I have Massachusetts insurance with online benefits access.

Access to a computer or tablet in the home

You need to have WiFi at your home to connect to the Mightier tablet.

Exclusion Criteria

Active suicidal ideation

I have significant difficulty speaking.

Evidence of psychosis, mania, alcohol use disorder, substance use disorder, or PTSD by MINI-Kid

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participating children are randomized into Mightier or treatment as usual control groups for 6 months

6 months

Follow-up

Behavioral healthcare utilization will be observed for 12 months to assess long-term outcomes

12 months

Treatment Details

Interventions

• Mightier video games

Trial Overview The trial tests Mightier video games designed to help kids manage their emotions better by using biofeedback technology. Children will either use Mightier or continue usual treatments for six months while their healthcare usage is tracked over a year to evaluate Mightier's effectiveness and impact on healthcare costs.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Six months of ad lib Mightier play in home

Group II: Treatment as usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Neuromotion Labs

Lead Sponsor

Trials

7

Recruited

3,600+

Magellan Healthcare

Collaborator

Trials

1

Recruited

200+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

An active biofeedback video game integrated into cognitive behavioral therapy has been developed to help children improve their emotional regulation skills by requiring them to manage emotions while completing a challenging task.

Early studies indicate that this approach is more effective than traditional treatments in enhancing emotional control, and it has inspired the creation of emotionally aware toys for younger children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"RAGE-Control": A Game to Build Emotional Strength. Kahn, J., Ducharme, P., Rotenberg, A., et al.[2015]

Video game-based assessment tools have been found effective in distinguishing between children with ADHD and those without, as well as identifying different ADHD subtypes, based on a review of 22 studies.

Video game-based therapeutic interventions are generally well accepted and effective in improving cognitive functions and reducing ADHD symptoms, with gamification and cognitive training being key mechanisms of their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video games for the assessment and treatment of attention-deficit/hyperactivity disorder: a systematic review. Peñuelas-Calvo, I., Jiang-Lin, LK., Girela-Serrano, B., et al.[2022]

In a randomized controlled trial with 72 children aged 7-12, the biofeedback-based video game Mightier significantly improved adaptive emotion regulation and reduced emotional dysregulation and behavioral issues after 6 weeks of use in a community setting.

Caregivers of children who played Mightier reported lower levels of parenting-related stress, suggesting that such interventions can benefit not only the children but also their families, especially in communities with limited access to traditional mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback-Based Videogames: Fostering Emotion Regulation at a Diverse Community Summer Camp. Mannweiler, M., Schuermann, H., Peechatka, A., et al.[2023]

Applied games, including serious games and gamification, can enhance mental health internet interventions by reaching more users, increasing engagement, and utilizing various therapeutic mechanisms.

There is promising evidence supporting the effectiveness of serious games for depression, but more independent trials and comparisons with traditional interventions are needed to fully understand their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Games and Gamification for Mental Health: Current Status and Promising Directions. Fleming, TM., Bavin, L., Stasiak, K., et al.[2022]

The video game MindLight, designed with evidence-based therapeutic techniques, has shown significant improvements in anxiety symptoms in children, with effects lasting up to 6 months after intervention, based on results from two randomized controlled trials.

Changes in specific in-game behaviors that reflect therapeutic techniques were found to predict reductions in anxiety symptoms three months after the children stopped playing, suggesting that engagement with these techniques is crucial for the game's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Game Play Behaviours during an Applied Video Game for Anxiety Prevention Predict Successful Intervention Outcomes. Wols, A., Lichtwarck-Aschoff, A., Schoneveld, EA., et al.[2023]

The FDA has approved EndeavorRx, a game-based digital therapeutic device, as the first of its kind for treating ADHD in children aged 8-12, specifically targeting inattentive or combined-type ADHD.

EndeavorRx has been shown to improve attention in pediatric patients, as measured by computer-based testing, indicating its potential efficacy as a non-pharmacological treatment option alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health interventions (DHI) for the treatment of attention deficit hyperactivity disorder (ADHD) in children - a comparative review of literature among various treatment and DHI. Pandian, GSB., Jain, A., Raza, Q., et al.[2021]

A systematic review of 49 studies involving 32 digital games shows that video game interventions can effectively support mental health treatment for young people aged 12-29, particularly for mild to moderate mental health conditions.

Stakeholder involvement in the development and evaluation of these games was high, indicating a collaborative approach, but the review noted a lack of attention to potential harms associated with these digital interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaming My Way to Recovery: A Systematic Scoping Review of Digital Game Interventions for Young People's Mental Health Treatment and Promotion. Ferrari, M., Sabetti, J., McIlwaine, SV., et al.[2022]

In a study of 101 youths with ADHD, emotional dysregulation was frequently observed in those with Internet Gaming Disorder (IGD), highlighting a significant link between gaming addiction and emotional challenges.

Treatment for IGD showed substantial efficacy, with symptoms of disruptive mood dysregulation decreasing by up to 84.4% over four weeks when ADHD symptoms were managed, suggesting that addressing ADHD can improve outcomes for those with IGD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Efficacy of Internet Gaming Disorder With Attention Deficit Hyperactivity Disorder and Emotional Dysregulaton. Chang, CH., Chang, YC., Cheng, H., et al.[2021]

Therapeutic video games like Treasure Hunt, Camp Cope-A-Lot, and SPARX have been developed to support the treatment of various mental health issues in children and adolescents, including anxiety and depression.

Despite the potential benefits of these games, the development of therapeutic video games is slow due to high costs and rigorous evaluation requirements, although they are expected to play a significant role in future psychotherapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New Developments in Video Games for Psychotherapy]. Brezinka, V.[2016]

RAGE Control is a computer-based intervention designed to help children improve emotional control by combining relaxation techniques with executive function tasks, like quick reaction games.

The program is based on Cognitive Behavioral Therapy principles and is currently used in clinical settings, suggesting its potential effectiveness in reducing reliance on psychotropic medications for emotional regulation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RAGE Control: Regulate and Gain Emotional Control. Kahn, J., Ducharme, P., Travers, B., et al.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

"RAGE-Control": A Game to Build Emotional Strength. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

Video games for the assessment and treatment of attention-deficit/hyperactivity disorder: a systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Biofeedback-Based Videogames: Fostering Emotion Regulation at a Diverse Community Summer Camp. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Serious Games and Gamification for Mental Health: Current Status and Promising Directions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

In-Game Play Behaviours during an Applied Video Game for Anxiety Prevention Predict Successful Intervention Outcomes. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Digital health interventions (DHI) for the treatment of attention deficit hyperactivity disorder (ADHD) in children - a comparative review of literature among various treatment and DHI. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Gaming My Way to Recovery: A Systematic Scoping Review of Digital Game Interventions for Young People's Mental Health Treatment and Promotion. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Treatment Efficacy of Internet Gaming Disorder With Attention Deficit Hyperactivity Disorder and Emotional Dysregulaton. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[New Developments in Video Games for Psychotherapy]. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

RAGE Control: Regulate and Gain Emotional Control. [2009]