RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play

Mass General Brigham

Status: Unknown

Conditions: Aggression; Anger

Treatments: Behavioral: Relaxation training plus Sham Videogame; Behavioral: Relaxation training plus RAGE-Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03270813

2015P000901

Details and patient eligibility

About

The purpose of this study is to evaluate the use of Regulate and Gain Emotional Control (RAGE-Control), a biofeedback video game, in combination with brief instruction in relaxation skills as an intervention for symptoms of anger and aggression in children and adolescents. Half of the research participants will learn relaxation techniques and practice them using the RAGE-Control videogame. The other half of the participants will learn relaxation techniques and play a similar videogame without the biofeedback component. The investigators hypothesize that participants in the RAGE-Control group will show a greater reduction in symptoms of anger and aggression than those in the non-RAGE-Control group.

Full description

Experiencing mild anger and aggression in frustrating situations is typical in childhood; however, over time most children develop the capacity to regulate their anger in emotionally provoking situations. Those who continue to struggle with emotional and behavioral regulation are at heightened risk for social isolation, delinquency, substance abuse, and academic problems later in life. Moreover, adults who were aggressive as children experience poor physical and mental health, and may find limited career opportunities.

Although anger regulation is a common and clinically significant psychiatric concern for children and adolescents, effective treatment options are limited. As a result, clinicians increasingly rely on psychotropic medications to blunt anger. Psychotropic medications can reduce anger and aggression in the short term, but they fail in the long-term goal of teaching self-regulation, and carry the risk of serious side-effects, including obesity, metabolic syndrome, and type II diabetes. However, engaging youth with anger issues in therapeutic treatments can be difficult, with high rates of attrition. These difficulties underline the need for innovative treatments that can effectively engage patients and enhance their ability to control their emotions and behaviors.

In response to this need, clinicians at Boston Children's Hospital developed Regulate and Gain Emotional Control (RAGE-Control), a therapeutic videogame that requires players to maintain low levels of physiologic arousal while rapidly reacting to incoming stimuli and inhibiting erroneous responses. It was initially designed for use with Cognitive Behavioral Therapy (CBT) to motivate children to remain engaged in therapy, and to foster the learning, practice, and generalization of self-regulation skills in the midst of frustrating or anger provoking situations. Pilot data from an open label trial of RAGE-Control on a pediatric psychiatric inpatient unit demonstrated improvement in patient self-reported anger and aggression after 5 sessions of CBT with RAGE-Control, when compared with a treatment as usual group. A subsequent outpatient randomized controlled trial comparing CBT with RAGE-Control to CBT with a sham videogame demonstrated that patients who participated in the RAGE-Control intervention had significantly greater improvements in overt aggression and oppositionality, parental stress, and family atmosphere. The participants in the RAGE-Control group also had fewer drop outs, and twice as many treatment responders as the participants in the control arm.

Enrollment: 40 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Problems with anger and/or aggression
• Score of at least 4/10 on phone screen with parents measuring anger and aggression

Exclusion criteria

• Changes in dosing of psychotropic medications within the 8 weeks prior to the start of the study, or anticipated medication changes during the study.
• Starting therapy within the 8 weeks prior to starting the study, or anticipated new therapy beginning during the study.
• Actively participating in any type of Cognitive Behavioral Therapy for less than 12 weeks and/or attending Cognitive Behavioral Therapy weekly or more.
• Intellectual disability (IQ < 80)
• Suicidal ideation
• Homicidal ideation
• Psychosis/meets criteria for psychotic disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

RAGE-Control

Experimental group

Description:

There are 6 research intervention sessions, which will involve Relaxation training plus RAGE-Control. The first session includes a 30-minute lesson on the relationship between physiological arousal and anger, introduction to the RAGE-Control videogame and 15 minutes of videogame play. The next 5 sessions include a 10-minute check in about symptoms and functioning, a brief presentation of a relaxation skill, and 15 minutes of videogame play.

Treatment:

Behavioral: Relaxation training plus RAGE-Control

Sham videogame

Sham Comparator group

Description:

There are 6 research intervention sessions, which will involve Relaxation training plus Sham videogame. The first session includes a 30-minute lesson on the relationship between physiological arousal and anger, an introduction to the Sham videogame and 15 minutes of videogame play. The next 5 sessions include a 10-minute check in about symptoms and functioning, a brief presentation of a relaxation skill, and 15 minutes of videogame play.

Treatment:

Behavioral: Relaxation training plus Sham Videogame