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

• ClinicalTrials.gov Identifier: NCT01551732
• Recruitment Status: Unknown
• First Posted: March 13, 2012
• Last Update Posted: April 21, 2020
• Sponsor: Gonzalez-Heydrich, Joseph, M.D.
• Information provided by (Responsible Party): Gonzalez-Heydrich, Joseph, M.D.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anger; Aggression	Behavioral: ACT; Behavioral: ACT with RAGE-Control	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger
• Actual Study Start Date: August 31, 2011
• Estimated Primary Completion Date: November 30, 2020
• Estimated Study Completion Date: November 30, 2020

Arms and Interventions

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 Name: 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 Name: CBT and biofeedback

Outcome Measures

Primary Outcome Measures :

1. State Trait Anger Expression Inventory - Child and Adolescent [ Time Frame: Baseline and two weeks Post treatment ]
   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.

Secondary Outcome Measures :

1. Disruptive Behavior Disorder Rating Scale (DBDRS) [ Time Frame: Baseline and two weeks post treatment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

United States, Massachusetts

Joseph Gonzalez-Heydrich

Boston, Massachusetts, United States, 02125

Sponsors and Collaborators

Gonzalez-Heydrich, Joseph, M.D.

Investigators

• Study Director: Joseph W Gonzalez-Heydrich, MD; Boston Children's Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Gonzalez-Heydrich, Joseph, M.D.
• ClinicalTrials.gov Identifier: NCT01551732
• Other Study ID Numbers: P00000440
• First Posted: March 13, 2012
• Last Update Posted: April 21, 2020
• Last Verified: April 2020

Keywords provided by Gonzalez-Heydrich, Joseph, M.D.:

Anger; Aggression; Biofeedback; Videogame

Additional relevant MeSH terms:

Aggression; Behavioral Symptoms