N/A
N=24
Intervention to Change Attributions That Are Negative (ICAN)
Trauma, Brain · Brain Injuries · Traumatic Brain Injury · Brain Injuries, Traumatic · Brain, Trauma
Bottom Line
View on ClinicalTrials.gov: NCT03648476 ↗Enrolled (actual)
24
Serious AEs
5.3%
Results posted
May 2022
Primary outcome: Primary: Change in Buss-Perry Aggression Questionnaire Score — -1.7; -5.91; -8.51 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ICAN (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Buss-Perry Aggression Questionnaire Score |
-1.7; -5.91; -8.51 | — |
| SECONDARY Change in Anger Affect Score |
-1.95; -.89; -4.49 | — |
| SECONDARY Global Impression of Change for Anger and Aggression |
4; 4 | — |
| SECONDARY Global Impression of Change for Perspective Taking and Empathy |
5; 6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03648476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.