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N/A N=24 Randomized Triple-blind Treatment

Intervention to Change Attributions That Are Negative (ICAN)

Trauma, Brain · Brain Injuries · Traumatic Brain Injury · Brain Injuries, Traumatic · Brain, Trauma

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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