Intermittent Explosive DisorderNCT04819230
A Cognitive Bias Modification RCT for Aggression
A study testing Cognitive Bias Modification in people with Intermittent Explosive Disorder, run by Temple University at 1 site in United States.
Trial summary
This randomized controlled trial will test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with primary aggression. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Intermittent Explosive Disorder
- What is being tested?
- Cognitive Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet DSM-5 criteria for current IED, as assessed via phone screen and confirmed during an in-person diagnostic interview conducted during visit one of the study
- Are able and willing to cooperate with study protocol; i.e. keep appointments, read and understand consent form, etc.
- Have written and verbal English proficiency for understanding consent and study materials
Who cannot join
- Have a lifetime history of psychosis
- Have current moderate to severe substance use disorder
- Have a history of bipolar disorder
- Have current major depressive disorder
- Are younger than 18 or older than 55 years old
- Are currently (past month) receiving treatment for anger or aggression
- Recently (past month) started or changed psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University
Philadelphia, Pennsylvania, 19122
Michael S McCloskey, Ph.D, 215-204-3738, mikemccloskey@temple.edu
Michael S McCloskey, Ph.D
About this study
Official title: Attention and Interpretation Bias Modification for Aggression Difficulties
This randomized controlled trial will test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with primary aggression.
Read the detailed description
The objective of the proposed study is to test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with Intermittent Explosive Disorder, a disorder characterized by habitual engagement in aggressive behavior. Efficacy of the CBM program will be assessed via a small randomized controlled trial comparing CBM to a computerized control condition. This training program would consist of a four-week regimen of twice-weekly 30-minute sessions (8 sessions total) during which individuals would learn to: (a) focus attention away from threatening words toward neutral words [attention bias], and (b) to disambiguate ambiguous interpersonal scenarios using more benign, rather than threatening, interpretations [interpretive bias]. Participants will be asked to complete behavioral measures of attention bias and interpretive bias, as well as self-report measures of anger / aggression, interpretive bias, emotion regulation and life satisfaction at baseline (pre-training), post-training, and 1-month follow-up.
- Conditions
- Intermittent Explosive Disorder
- Being tested
- Cognitive Bias Modification, Cognitive Bias Control
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias ModificationBehavioural
A four-week computerized attentional and interpretive bias modification protocol in which participants complete both ATT and ITT tasks twice per week, totaling to eight experimental sessions (see experimental arm for more detail.)
Cognitive Bias ControlBehavioural
A four-week computerized attentional and interpretive stimuli protocol in which participants complete both ATT-C and ITT-C tasks twice per week, totaling to eight control sessions (see placebo control arm for more detail.)
| Study group | Role | What they receive |
|---|---|---|
| Bias Modification | Experimental | Attention (ATT) and interpretation (ITT) bias training. Participants complete the ATT and ITT tasks twice per week for four weeks. The ATT trains attention toward neutral stimuli and away from negative stimuli. On trials with one neutral and one threat word, the probe will always follow the location of the neutral word. Therefore, there is a contingency between the valence of the word and the location of the probe. Participants will be asked to indicate which type of probe had appeared in each trial by pressing a corresponding button as rapidly and accurately as possible. The ITT trains participants to make benign (vs. threatening) interpretations of socially-ambiguous scenarios. For each trial, a word suggesting a socially threatening or benign interpretation is presented then replaced by a sentence describing a socially-ambiguous scenario. Participants indicate if they thought the word and sentence were related. Participants will receive corrective feedback after each trial. Receives: Behavioral: Cognitive Bias Modification |
| Control Condition | Placebo comparator | A combination of attention (ATT-C) and interpretation (ITT-C) control tasks
These tasks are identical to the experimental tasks (ATT and ITT) with the exceptions that:
ATT-C: It is designed to train attention toward neither neutral nor the threat stimuli. This will be achieved by having an equal number of probes follow the location of the threatening word and the neutral word.
ITT-C: It is not designed to train benign interpretations of ambiguous social scenarios. Thus, no feedback will be given during the inter-trial interval, rather participants will see a blank screen between trials.
Participants will complete both the ATT-C and ITT-C tasks twice per week for four weeks, totaling to eight experimental sessions. Receives: Behavioral: Cognitive Bias Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Overt Aggression Scale-Modified (higher score means more aggression)
Measured: preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months
Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
State-Trait Anger Expression Inventory-2:state anger scale modified(higher score means more anger)
Measured: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Social Information Processing - Attribution and Emotional Response Questionnaire
Measured: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Secondary outcomes (2)
Change in Emotion Regulation from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Difficulty in Emotion Regulation Scale (higher score means greater emotion dysregulation)
Measured: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Change in IED diagnosis from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Intermittent Explosive Disorder-Module (presence vs absence of current disorder)
Measured: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent Explosive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael McCloskey, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819230
- Sponsor's protocol ID
- 27093
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention and Interpretation Bias Modification for Aggression Difficulties
- ClinicalTrials.gov ID
- NCT04819230
- Acronym / sponsor ID
- 27093
- Conditions
- Intermittent Explosive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with primary aggression.
Detailed description
The objective of the proposed study is to test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with Intermittent Explosive Disorder, a disorder characterized by habitual engagement in aggressive behavior. Efficacy of the CBM program will be assessed via a small randomized controlled trial comparing CBM to a computerized control condition. This training program would consist of a four-week regimen of twice-weekly 30-minute sessions (8 sessions total) during which individuals would learn to: (a) focus attention away from threatening words toward neutral words [attention bias], and (b) to disambiguate ambiguous interpersonal scenarios using more benign, rather than threatening, interpretations [interpretive bias]. Participants will be asked to complete behavioral measures of attention bias and interpretive bias, as well as self-report measures of anger / aggression, interpretive bias, emotion regulation and life satisfaction at baseline (pre-training), post-training, and 1-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bias Modification | Experimental | Behavioral: Cognitive Bias ModificationAttention (ATT) and interpretation (ITT) bias training. Participants complete the ATT and ITT tasks twice per week for four weeks. The ATT trains attention toward neutral stimuli and away from negative stimuli. On trials with one neutral and one threat word, the probe will always follow the location of the neutral word. Therefore, there is a contingency between the valence of the word and the location of the probe. Participants will be asked to indicate which type of probe had appeared in each trial by pressing a corresponding button as rapidly and accurately as possible. The ITT trains participants to make benign (vs. threatening) interpretations of socially-ambiguous scenarios. For each trial, a word suggesting a socially threatening or benign interpretation is presented then replaced by a sentence describing a socially-ambiguous scenario. Participants indicate if they thought the word and sentence were related. Participants will receive corrective feedback after each trial. |
| Control Condition | Placebo comparator | Behavioral: Cognitive Bias ControlA combination of attention (ATT-C) and interpretation (ITT-C) control tasks These tasks are identical to the experimental tasks (ATT and ITT) with the exceptions that: ATT-C: It is designed to train attention toward neither neutral nor the threat stimuli. This will be achieved by having an equal number of probes follow the location of the threatening word and the neutral word. ITT-C: It is not designed to train benign interpretations of ambiguous social scenarios. Thus, no feedback will be given during the inter-trial interval, rather participants will see a blank screen between trials. Participants will complete both the ATT-C and ITT-C tasks twice per week for four weeks, totaling to eight experimental sessions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meet DSM-5 criteria for current IED, as assessed via phone screen and confirmed during an in-person diagnostic interview conducted during visit one of the study
- Are able and willing to cooperate with study protocol; i.e. keep appointments, read and understand consent form, etc.
- Have written and verbal English proficiency for understanding consent and study materials
Key exclusion criteria (7 listed)
- Have a lifetime history of psychosis
- Have current moderate to severe substance use disorder
- Have a history of bipolar disorder
- Have current major depressive disorder
- Are younger than 18 or older than 55 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Bias ModificationA four-week computerized attentional and interpretive bias modification protocol in which participants complete both ATT and ITT tasks twice per week, totaling to eight experimental sessions (see experimental arm for more detail.) | Behavioural | Bias Modification |
| Cognitive Bias ControlA four-week computerized attentional and interpretive stimuli protocol in which participants complete both ATT-C and ITT-C tasks twice per week, totaling to eight control sessions (see placebo control arm for more detail.) | Behavioural | Control Condition |
Primary outcome
Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Time frame: preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months
Overt Aggression Scale-Modified (higher score means more aggression)
Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Time frame: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
State-Trait Anger Expression Inventory-2:state anger scale modified(higher score means more anger)
Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Time frame: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Social Information Processing - Attribution and Emotional Response Questionnaire
2 secondary outcomes
Change in Emotion Regulation from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Time frame: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Change in IED diagnosis from pretreatment to end of treatment (4 weeks later) and 1-month follow-up
Time frame: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification in people with Intermittent Explosive Disorder, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up (time frame: preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.