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

Primary Purpose

Anger, Aggression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT
ACT with RAGE-Control
Sponsored by
Gonzalez-Heydrich, Joseph, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anger focused on measuring Anger, Aggression, Biofeedback, Videogame

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Joseph Gonzalez-Heydrich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Anger Control Therapy

ACT with RAGE-Control

Arm Description

10 session manualized cognitive behavioral anger control therapy

10 session manualized cognitive behavioral anger control therapy augmented with an interactive biofeedback videogame.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 31, 2011
Last Updated
April 19, 2020
Sponsor
Gonzalez-Heydrich, Joseph, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01551732
Brief Title
Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger
Official Title
Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2011 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gonzalez-Heydrich, Joseph, M.D.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anger, Aggression
Keywords
Anger, Aggression, Biofeedback, Videogame

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anger Control Therapy
Arm Type
Active Comparator
Arm Description
10 session manualized cognitive behavioral anger control therapy
Arm Title
ACT with RAGE-Control
Arm Type
Experimental
Arm Description
10 session manualized cognitive behavioral anger control therapy augmented with an interactive biofeedback videogame.
Intervention Type
Behavioral
Intervention Name(s)
ACT
Other Intervention Name(s)
CBT
Intervention Description
10 session manualized cognitive behavioral anger control therapy
Intervention Type
Behavioral
Intervention Name(s)
ACT with RAGE-Control
Other Intervention Name(s)
CBT and biofeedback
Intervention Description
10 session manualized cognitive behavioral anger control therapy augmented with interactive biofeedback videogame.
Primary Outcome Measure Information:
Title
State Trait Anger Expression Inventory - Child and Adolescent
Description
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.
Time Frame
Baseline and two weeks Post treatment
Secondary Outcome Measure Information:
Title
Disruptive Behavior Disorder Rating Scale (DBDRS)
Description
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.
Time Frame
Baseline and two weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph W Gonzalez-Heydrich, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Joseph Gonzalez-Heydrich
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34539455
Citation
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.
Results Reference
derived

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

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