Intervention to Change Attributions That Are Negative (ICAN)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Intervention to Change Attributions That Are Negative (ICAN): a New Approach to Reducing Anger and Aggression After Brain Injury

Conditions
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Trauma, Brain, Brain Injuries, Traumatic Brain Injury, Brain Injuries, Traumatic, Brain, Trauma

Intervention / Treatment
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* Behavioral: ICAN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICAN<br>6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing | Behavioral: ICAN<br>* A 6-week group therapy sessions once a week for 90-120 minutes.<br>|
| Other: WLC: Waitlist Control<br>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. | Behavioral: ICAN<br>* A 6-week group therapy sessions once a week for 90-120 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline at Week 8 and Week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anger, Aggression, Hostility