Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger

The purpose of this study is to determine whether adding an interactive biofeedback video game to anger control cognitive behavioral therapy is an effective and feasible treatment.

Study Overview

• Status: Unknown
• Conditions: Anger; Aggression
• Intervention / Treatment: Behavioral: ACT; Behavioral: ACT with RAGE-Control

Detailed Description

Current treatments for pathological anger and aggression in youth are lacking in their effectiveness to motivate and engage patients in treatment. As a result, mental health providers encounter challenges due to the limited generalizability of treatment effects to real-world situations outside of the therapist's office. When behavioral treatments fail to show lasting results, children and adolescents are often placed on antipsychotic medication to control their behaviors, which may result in significant toxicity levels and for which there is limited knowledge of the long-term effects on pediatric growth and development. This study tests an interactive biofeedback video game called RAGE-Control (for Regulate and Gain Emotional-Control) as a treatment for youth exhibiting anger and aggression. Treatment with RAGE-Control seeks to motivate children and adolescents to learn and practice coping skills taught in therapy within the environment of a fun and enjoyable video game. The game provides patients a venue to practice self-regulation techniques in response to the increasing stress of the game. Providing patients with the opportunity to refine their self-regulation skills in a fast-paced challenging game is hypothesized to result in greater generalization of therapeutic skills to situations outside of the therapist's office. The goal of the treatment is to decrease patients' feelings of anger, and to increase the patients' levels of control in their emotional and behavioral responses.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02125
      • Joseph Gonzalez-Heydrich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 10 to17 years old (inclusive).
• STAXI-CA score >15 on the Trait Anger subscales.

Exclusion Criteria:

• Inability to consent, comprehend, or effectively participate in the study.
• Cognitive impairment, defined as IQ < 75.
• Change in mood stabilizing and/or anti-psychotic medication dose within 4 weeks of beginning the study or anticipation of medication changes during the study period (10 weeks).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anger Control Therapy; 10 session manualized cognitive behavioral anger control therapy	Behavioral: ACT; 10 session manualized cognitive behavioral anger control therapy; Other Names: CBT
Experimental: ACT with RAGE-Control; 10 session manualized cognitive behavioral anger control therapy augmented with an interactive biofeedback videogame.	Behavioral: ACT with RAGE-Control; 10 session manualized cognitive behavioral anger control therapy augmented with interactive biofeedback videogame.; Other Names: CBT and biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Trait Anger Expression Inventory - Child and Adolescent	This is a 35 item self-report measure of patients' subjective feelings of anger and aggression administered at the baseline assessment prior to the first session and again two weeks post treatment.	Baseline and two weeks Post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disruptive Behavior Disorder Rating Scale (DBDRS)	This is an interview conducted by an investigator who is blinded to the patient's treatment assignment. The investigator conducts this interview with the patient's parent/ guardian at baseline prior to the first session and again two weeks post treatment.	Baseline and two weeks post treatment

Collaborators and Investigators

• Sponsor: Gonzalez-Heydrich, Joseph, M.D.
• Investigators: Study Director: Joseph W Gonzalez-Heydrich, MD, Boston Children's Hospital

Publications and helpful links

General Publications

• Ducharme P, Kahn J, Vaudreuil C, Gusman M, Waber D, Ross A, Rotenberg A, Rober A, Kimball K, Peechatka AL, Gonzalez-Heydrich J. A "Proof of Concept" Randomized Controlled Trial of a Video Game Requiring Emotional Regulation to Augment Anger Control Training. Front Psychiatry. 2021 Sep 1;12:591906. doi: 10.3389/fpsyt.2021.591906. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2011
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Anger; Aggression; Biofeedback; Videogame
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• Other Study ID Numbers: P00000440