Trauma, BrainICANNCT03648476
Intervention to Change Attributions That Are Negative (ICAN)
A study testing ICAN in people with Trauma, Brain and Brain Injuries, run by Indiana University at 1 site in United States.
Trial summary
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. This is a randomized waitlist control trial. The length of time in the trial is approximately 15 weeks and the intervention is 6 weeks long. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Brain, Brain Injuries, Traumatic Brain Injury
- What is being tested?
- ICAN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2018to 11 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of complicated mild to severe TBI (injury due to an external physical force), with injury severity being defined either by Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes), or positive head CT scan consistent with TBI.
- At least 18 years of age or older;
- ≥1 year post-injury;
- Have adequate vision, hearing, and speech/ language skills to participate in assessments and group therapy (determined based on interaction with the participant at screening)
- Have adequate reading comprehension (due to the primary assessment involving written scenarios)
- Have abnormal scores of negative attributions or perspective taking (determined at T0 screening)
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- Have above average aggression (prescreened on telephone, and confirmed T0 screening).
- No anticipated medication changes for emotions/ behavior during length of study participation; medications for emotions/ behavior must be stable within last 30 days prior to consent at T0 (Screening)
- Have reliable mode of transportation
Who cannot join
- Pre-morbid neurological disorders that could affect mood and cognition (e.g. stroke); does not include controlled seizures
- Progressive central nervous system disorders (e.g. dementia, Parkinson's)
- Developmental disability (e.g., autism, developmental delay);
- Major psychiatric disorders (e.g. schizophrenia, Borderline Personality Disorder);
- Severe Depression and/or perceived risk to self or others (mental health resources will be provided and if suicide risk, approved suicide protocol will be utilized);
- Currently receiving active behavioral therapy for anger.
- On drug research study for irritability, anger, aggression
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
About this study
Official title: Intervention to Change Attributions That Are Negative (ICAN): a New Approach to Reducing Anger and Aggression After Brain Injury
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. This is a randomized waitlist control trial. The length of time in the trial is approximately 15 weeks and the intervention is 6 weeks long.
Read the detailed description
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. Since the investigator's prior research shows that stronger hostile attributions are associated with poorer perspective taking,39 ICAN employs a unique perspective-positioning technique to train perspective taking and reduce hostile attributions. After recalling a personal situation in which others' ambiguous actions led to an unpleasant outcome, participants will explore different perspectives: sitting or standing in one position, s/he will explore his or her own thoughts and feelings (self-perspective), then move to a different position to experience the other person's perspective, eliciting their thoughts and feelings.
In 40 participants with TBI, we will conduct a Phase I, randomized waitlist controlled trial with 4 data collection points: Baseline; Week 1; Week 8 (post-treatment for ICAN; post-wait period for WLC); Week 15 (WLC post-treatment).
- Conditions
- Trauma, Brain, Brain Injuries, Traumatic Brain Injury, Brain Injuries, Traumatic, Brain, Trauma
- Being tested
- ICAN
- Keywords
- Anger, Aggression, Hostility
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICANBehavioural
A 6-week group therapy sessions once a week for 90-120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ICAN | Experimental | 6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing Receives: Behavioral: ICAN |
| WLC: Waitlist Control | Other | WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions. Receives: Behavioral: ICAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Buss-Perry Aggression Questionnaire Score
The Buss-Perry Aggression Questionnaire (AQ), is a standardized measure comprised of 34 statements to assess total aggression, as well as the following aggression subconstructs: anger, hostile thoughts, and physical and verbal aggression. Participants rate statements using a 5-point Likert scale (1, 2, 3, 4, 5).
Subscales are summed to compute a Total Aggression raw score and total Aggressions Scores were then converted to T scores (1-100) with a mean T-score =50 and Standard deviation=10 points.
Higher T-scores= more aggression/ worse outcome, thus a lower number indicates improvement Here, we are reporting the CHANGE in the group's MEAN t-score (e.g. Mean Post-test T score of 62 MINUS Mean Pre-test t score of 58 = Mean CHANGE score of -4, which means less aggression post-treatment). Thus, we are NOT reporting t-scores in this Results section; just the mean change of these scores. Negative scores indicate an improvement.
Measured: Change from Baseline at Week 8 and Week 15
Secondary outcomes (3)
Change in Anger Affect Score
The Anger-Affect Scale, from the PROMIS Anger, is a 5 item subjective questionnaire that requires participants to indicate the frequency with which they have been bothered by anger symptoms in the past week using a 5 point Likert scale (1.2,3,4,5). Total Raw scores range from 5-25. Higher scores indicate more severe anger; lower scores indicate lower levels of anger. Thus, a negative change score indicates a reduction in anger.
Measured: Change from Week 1 at Week 8 and Week 15
Global Impression of Change for Anger and Aggression
The Global Impression of change for Anger and Aggression is a 1 item question that measures perceived change in anger and aggression Using a 7-point scale (1="no change" to "A great deal better, and a considerable improvement that has made all the difference"). Total Raw scores range from 1-7.Higher scores indicate greater change.
- No change (or condition has gotten worse)
- Almost the same, hardly any change at all
- A little better, but no noticeable change
- Somewhat better, but the change has not made any real difference
- Moderately better, and a slight but noticeable change
- Better, and a definite improvement that has made a real and worthwhile difference
- A great deal better, and a considerable improvement that has made all the difference
Measured: Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment)
Global Impression of Change for Perspective Taking and Empathy
The Global Impression of change for Perspective Taking and Empathy is a 1 item question that measures perceived change in Perspective Taking and Empathy using a 7-point scale (1="no change" to "A great deal better, and a considerable improvement that has made all the difference"). Total Raw scores range from 1-7.Higher scores indicate greater change.
- No change (or condition has gotten worse)
- Almost the same, hardly any change at all
- A little better, but no noticeable change
- Somewhat better, but the change has not made any real difference
- Moderately better, and a slight but noticeable change
- Better, and a definite improvement that has made a real and worthwhile difference
- A great deal better, and a considerable improvement that has made all the difference
Measured: Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start2 Nov 2018
- Primary completion23 Nov 2020
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trauma, BrainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Dawn Neumann, Indiana University
- Investigators
- Dawn Neumann, Phd, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648476
- Sponsor's protocol ID
- 1806829789
- Other IDs
- 1R21HD094232-01
- Acronym
- ICAN
- Status last verified
- May 2022
- First submitted
- 20 Aug 2018
- Last updated
- 23 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Change Attributions That Are Negative (ICAN): a New Approach to Reducing Anger and Aggression After Brain Injury
- ClinicalTrials.gov ID
- NCT03648476
- Acronym / sponsor ID
- ICAN / 1806829789
- Conditions
- Trauma, Brain, Brain Injuries, Traumatic Brain Injury, Brain Injuries, Traumatic, Brain, Trauma
- Keywords
- Anger, Aggression, Hostility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Posted 23 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. This is a randomized waitlist control trial. The length of time in the trial is approximately 15 weeks and the intervention is 6 weeks long.
Detailed description
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. Since the investigator's prior research shows that stronger hostile attributions are associated with poorer perspective taking,39 ICAN employs a unique perspective-positioning technique to train perspective taking and reduce hostile attributions. After recalling a personal situation in which others' ambiguous actions led to an unpleasant outcome, participants will explore different perspectives: sitting or standing in one position, s/he will explore his or her own thoughts and feelings (self-perspective), then move to a different position to experience the other person's perspective, eliciting their thoughts and feelings.
In 40 participants with TBI, we will conduct a Phase I, randomized waitlist controlled trial with 4 data collection points: Baseline; Week 1; Week 8 (post-treatment for ICAN; post-wait period for WLC); Week 15 (WLC post-treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICAN | Experimental | Behavioral: ICAN6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing |
| WLC: Waitlist Control | Other | Behavioral: ICANWLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of complicated mild to severe TBI (injury due to an external physical force), with injury severity being defined either by Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes), or positive head CT scan consistent with TBI.
- At least 18 years of age or older;
- ≥1 year post-injury;
- Have adequate vision, hearing, and speech/ language skills to participate in assessments and group therapy (determined based on interaction with the participant at screening)
- Have adequate reading comprehension (due to the primary assessment involving written scenarios)
Key exclusion criteria (7 listed)
- Pre-morbid neurological disorders that could affect mood and cognition (e.g. stroke); does not include controlled seizures
- Progressive central nervous system disorders (e.g. dementia, Parkinson's)
- Developmental disability (e.g., autism, developmental delay);
- Major psychiatric disorders (e.g. schizophrenia, Borderline Personality Disorder);
- Severe Depression and/or perceived risk to self or others (mental health resources will be provided and if suicide risk, approved suicide protocol will be utilized);
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 |
|---|---|---|
| ICANA 6-week group therapy sessions once a week for 90-120 minutes. | Behavioural | ICAN, WLC: Waitlist Control |
Primary outcome
Change in Buss-Perry Aggression Questionnaire Score
Time frame: Change from Baseline at Week 8 and Week 15
The Buss-Perry Aggression Questionnaire (AQ), is a standardized measure comprised of 34 statements to assess total aggression, as well as the following aggression subconstructs: anger, hostile thoughts, and physical and verbal aggression. Participants rate statements using a 5-point Likert scale (1, 2, 3, 4, 5). Subscales are summed to compute a Total Aggression raw score and total Aggressions Scores were then converted to T scores (1-100) with a mean T-score =50 and Standard deviation=10 points. Higher T-scores= more aggression/ worse outcome, thus a lower number indicates improvement Here, we are reporting the CHANGE in the group's MEAN t-score (e.g. Mean Post-test T score of 62 MINUS Mean Pre-test t score of 58 = Mean CHANGE score of -4, which means less aggression post-treatment). Thus, we are NOT reporting t-scores in this Results section; just the mean change of these scores. Negative scores indicate an improvement.
3 secondary outcomes
Change in Anger Affect Score
Time frame: Change from Week 1 at Week 8 and Week 15
Global Impression of Change for Anger and Aggression
Time frame: Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment)
Global Impression of Change for Perspective Taking and Empathy
Time frame: Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dawn Neumann, Phd principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICAN in people with Trauma, Brain and Brain Injuries, run by Indiana 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 9 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: finished, as of the sponsor's last update on 23 May 2022. 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. 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?
Yes. Results are posted in the registry (first posted 23 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Buss-Perry Aggression Questionnaire Score (time frame: Change from Baseline at Week 8 and Week 15). 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 23 May 2022.