NCT03684031

Brief Summary

High trait anger is a personality construct characterized by elevations in the frequency, duration, and intensity of anger episodes. According to many social cognitive theories, hostile interpretations of everyday situations contribute to the development and maintenance of anger symptoms. This study will examine the effectiveness of a computer-based cognitive control training task.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

September 22, 2018

Last Update Submit

March 23, 2020

Conditions

Keywords

Reactive AggressionAngerCognitive Control TrainingAnger Rumination

Outcome Measures

Primary Outcomes (2)

  • State-Trait Anger Expression Inventory 2nd Edition

    A self-report measure of the experience of anger.

    Administered two times over the course of one week. Changes will be examined from visit 1 (before CCT training program) to visit 2 (after CCT training program)

  • Computer-based cognitive control assessment

    A behavioural measure of hostility-primed cognitive control involving aggressive and neutral words.

    Administered two times over the course of one week. Changes will be examined from visit 1 (before CCT training program) to visit 2 (after CCT training program)

Secondary Outcomes (6)

  • Anger Rumination Scale

    Administered two times over the course of one week. Changes will be examined from visit 1 (before CCT training program) to visit 2 (after CCT training program)

  • Depression and Anxiety Stress Scale-21 (DASS-21)

    Administered two times over the course of one week. Changes will be examined from visit 1 (before CCT training program) to visit 2 (after CCT training program)

  • Dot probe task

    Administered two times over the course of one week. Changes will be examined from visit 1 (before CCT training program) to visit 2 (after CCT training program)

  • Adult Temperament Questionnaire (Effortful Control section)

    Administered two times over the course of one week. Changes will be examined from visit 1 (before CCT training program) to visit 2 (after CCT training program)

  • Reactive-Proactive Aggression Questionnaire

    Administered two times over the course of one week. Changes will be examined from visit 1 (before CCT training program) to visit 2 (after CCT training program)

  • +1 more secondary outcomes

Study Arms (2)

Cognitive Control Training

EXPERIMENTAL

Participants in this arm will complete a computer-based training program two times in the lab. Participants will complete the first training session in the lab during their initial visit and they will return to the lab one week later to complete the second session.

Behavioral: Cognitive Control Training

Sham Cognitive Control Training Program

SHAM COMPARATOR

Participants in this arm will complete a sham training program two times in the lab. The program will look similar in length and design to the experimental training program, but the content of the program will remain affectively neutral. As in the experimental condition, participants will complete the first training session in the lab during their initial visit and they will return to the lab one week later to complete the second session.

Behavioral: Sham Cognitive Control Training Program

Interventions

A computer-based flanker task that aims to reinforce the recruitment of cognitive control in the presence of hostile/aggressive stimuli.

Cognitive Control Training

A placebo version of the computer-based cognitive control training. Designed to appear similar to the experimental task, but will not reinforce the recruitment of cognitive control in the presence of hostile/aggressive stimuli.

Sham Cognitive Control Training Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Score of 22 or higher on the Trait Anger Scale.

You may not qualify if:

  • Reports currently receiving psychological treatment or counseling for anger management difficulties.
  • Reports changes in psychiatric medication within the last month.
  • Endorsement of current psychosis or bipolar disorder symptoms.
  • Indicates poor English language proficiency.
  • Reports clinically significant suicidal ideation, intent, or plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (1)

  • Wilkowski BM, Robinson MD. The cognitive basis of trait anger and reactive aggression: an integrative analysis. Pers Soc Psychol Rev. 2008 Feb;12(1):3-21. doi: 10.1177/1088868307309874. Epub 2007 Dec 18.

    PMID: 18453470BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Monique D Tremblay, M.A Ryerson University

Study Record Dates

First Submitted

September 22, 2018

First Posted

September 25, 2018

Study Start

April 30, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

The results of this study will be disseminated through conference presentations, journal publications, and through the lab website. Anonymized aggregate participant data may be made available upon request to a publishing journal or individual research group. However, research groups interested in accessing anonymized data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.

Locations