NCT01551732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 31, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

9.3 years

First QC Date

August 31, 2011

Last Update Submit

April 19, 2020

Conditions

Keywords

AngerAggressionBiofeedbackVideogame

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Disruptive Behavior Disorder Rating Scale (DBDRS)

    Baseline and two weeks post treatment

Study Arms (2)

Anger Control Therapy

ACTIVE COMPARATOR

10 session manualized cognitive behavioral anger control therapy

Behavioral: ACT

ACT with RAGE-Control

EXPERIMENTAL

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

Behavioral: ACT with RAGE-Control

Interventions

ACTBEHAVIORAL

10 session manualized cognitive behavioral anger control therapy

Also known as: CBT
Anger Control Therapy

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

Also known as: CBT and biofeedback
ACT with RAGE-Control

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph Gonzalez-Heydrich

Boston, Massachusetts, 02125, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Aggression

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Joseph W Gonzalez-Heydrich, MD

    Boston Children's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2011

First Posted

March 13, 2012

Study Start

August 31, 2011

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations