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

Aggression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01551732
• Other study ID #: P00000440
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2011
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2020
• Source: Gonzalez-Heydrich, Joseph, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aggression
• Anger

Intervention

Behavioral:
• ACT
10 session manualized cognitive behavioral anger control therapy
• ACT with RAGE-Control
10 session manualized cognitive behavioral anger control therapy augmented with interactive biofeedback videogame.

Locations

Country	Name	City	State
United States	Joseph Gonzalez-Heydrich	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Gonzalez-Heydrich, Joseph, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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