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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gonzalez-Heydrich, Joseph, M.D.
ClinicalTrials.gov Identifier:
NCT01551732
First received: August 31, 2011
Last updated: September 3, 2013
Last verified: September 2013

August 31, 2011
September 3, 2013
July 2011
November 2013   (final data collection date for primary outcome measure)
State Trait Anger Expression Inventory - Child and Adolescent [ Time Frame: Baseline and two weeks Post treatment ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01551732 on ClinicalTrials.gov Archive Site
Disruptive Behavior Disorder Rating Scale (DBDRS) [ Time Frame: Baseline and two weeks post treatment ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Anger
  • Aggression
  • Behavioral: ACT
    10 session manualized cognitive behavioral anger control therapy
    Other Name: CBT
  • Behavioral: ACT with RAGE-Control
    10 session manualized cognitive behavioral anger control therapy augmented with interactive biofeedback videogame.
    Other Name: CBT and biofeedback
  • Active Comparator: Anger Control Therapy
    10 session manualized cognitive behavioral anger control therapy
    Intervention: Behavioral: ACT
  • Experimental: ACT with RAGE-Control
    10 session manualized cognitive behavioral anger control therapy augmented with an interactive biofeedback videogame.
    Intervention: Behavioral: ACT with RAGE-Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
November 2013
November 2013   (final data collection date for primary outcome measure)

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).
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01551732
P00000440
No
Gonzalez-Heydrich, Joseph, M.D.
Gonzalez-Heydrich, Joseph, M.D.
Not Provided
Principal Investigator: Peter W Ducharme, MSW Children's Hospital Boston
Gonzalez-Heydrich, Joseph, M.D.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP