- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03684031
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
50
Phase
- 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
-
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Ontario
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Toronto, Ontario, Canada, M5B 2K3
- Ryerson University
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-
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
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:
- 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.
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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.
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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
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)
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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
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.
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)
April 30, 2019
Primary Completion (ACTUAL)
March 13, 2020
Study Completion (ACTUAL)
March 13, 2020
Study Registration Dates
First Submitted
September 22, 2018
First Submitted That Met QC Criteria
September 22, 2018
First Posted (ACTUAL)
September 25, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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