Impact of Cognitive Control Training on Anger Symptoms and Reactive Aggression

March 23, 2020 updated by: Monique Tremblay, Ryerson University

Impact of Cognitive Control Training on Anger Symptoms and Reactive Aggression (Anger Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Difficulties with anger control are reported in a number of psychological conditions and are associated with social problems, such as dating violence and workplace violence. High trait anger is a personality construct characterized by elevations in the frequency, duration, and intensity of anger episodes. However, the cognitive processes contributing to high trait anger are still poorly understood. According to the Integrative Cognitive Model of Anger and Reactive Aggression (ICM), three cognitive processes jointly contribute to the experience of high trait anger and reactive aggression: 1) hostile interpretation biases; 2) cognitive control; and 3) anger rumination. The proposed study will evaluate the validity of this model in relation to cognitive control using a computer-based cognitive control training (CCT) program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • Ryerson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Score of 22 or higher on the Trait Anger Scale.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cognitive Control Training
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
A computer-based flanker task that aims to reinforce the recruitment of cognitive control in the presence of hostile/aggressive stimuli.
SHAM_COMPARATOR: Sham Cognitive Control Training Program
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
State-Trait Anger Expression Inventory 2nd Edition
Time Frame: 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)
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
Time Frame: 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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anger Rumination Scale
Time Frame: 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)
A self-report measure of the degree to individuals focus on experiences with anger. The scale is comprised of four subscales, angry after thoughts (e.g., "Whenever I experience anger, I keep thinking about it for a while"), angry memories (e.g., "I re-enact the anger episode in my mind after it has happened"), understanding causes (e.g., "When someone provokes me, I keep wondering why this should have happened to me"), and thoughts of revenge (e.g. "I have difficulty forgiving people who have hurt me."). Participants will be asked to read each item and rate it in terms of how well it reflects their experience on a 4-point scale from 1 ("almost never") to 4 ("almost always"). Totals for each sub scale will be summed to produce a total score (range: 19-76), with higher scores indicating a greater propensity for rumination.
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)
Time Frame: 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)
A self-report measure of depression, anxiety, and stress symptoms.Items are summed for each subscale to create subscale totals (i.e., depression, anxiety, and stress), with higher scores reflecting more severe emotional distress. Symptom score ranges include: normal (0-4), mild (5-6), moderate (7-10), severe (11-13), and extremely severe (14+).
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
Time Frame: 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)
A behavioural measure of attentional bias towards angry faces.
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)
Time Frame: 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)
A self-report measure of one's ability to suppress inappropriate approach behavior, to perform an action when there is a strong tendency to avoid it, and to shift or focus behaviour.
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
Time Frame: 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)
A self-report measure of an individual's propensity for reactive aggression.
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)
Taylor Aggression Paradigm
Time Frame: Administered one time over the course of one week. Participants will be exposed to the paradigm following the second training session.]
A behavioural measure of reactive aggression.
Administered one time over the course of one week. Participants will be exposed to the paradigm following the second training session.]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ryerson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Anger Study 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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