Indianapolis, Indiana 46254


Purpose:

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 15 weeks and the intervention is 6 weeks long.


Study summary:

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; Posttest I (post-treatment for ICAN; post-wait period for WLC); Posttest II (WLC post-treatment).


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; medica-tions 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) - 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


NCT ID:

NCT03648476


Primary Contact:

Principal Investigator
Dawn Neumann, Phd
Indiana University School of Medicine

Ryan Mayfield
Phone: 3173292380
Email: rymayfie@iu.edu


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46254
United States

Ryan Mayfield
Phone: 317-329-2380
Email: rymayfie@iu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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