Clinical trial NCT03648476: Intervention to Change Attributions That Are Negative (ICAN)
Official title: Intervention to Change Attributions That Are Negative (ICAN): a New Approach to Reducing Anger and Aggression After Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma, Brain
Brain Injuries
Traumatic Brain Injury
Brain Injuries, Traumatic
Brain, Trauma
Keywords: Anger
Aggression
Hostility
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-08-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

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

Primary outcomes:
measure: Change in Buss-Perry Aggression Questionnaire Score
timeFrame: Change from Baseline at Week 8 and Week 15
Secondary outcomes:
measure: Change in Anger Affect Score
timeFrame: Change from Week 1 at Week 8 and Week 15
measure: Global Impression of Change for Anger and Aggression
timeFrame: Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment)
measure: Global Impression of Change for Perspective Taking and Empathy
timeFrame: Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment)
Other outcomes:
measure: Change in Interpersonal Reactivity Index (IRI) - Perspective Taking and Empathic Concern Score
timeFrame: Change from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15
measure: Change in Attributions of Hostility, Intent, Blame, and Anger (Epps Hypothetical Scenarios) Score
timeFrame: Change from Baseline at Week 8 and Week 15
measure: Change in The Awareness of Social Inference Test (TASIT) Score
timeFrame: Change from Baseline at Week 8 and Week 15
measure: Change in Difficulty With Emotion Regulation Scale (DERS) Score
timeFrame: Change from Week 1 at Week 8 and Week 15
measure: Change in The Ambiguous Intentions Hostility Questionnaire (AIHQ) Score
timeFrame: Change from Baseline or Week 1(depending on when collected) at Week 8 and Week 15
Locations:
city: Indianapolis
country: United States
facility: The Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Dawn Neumann, Phd
role: PRINCIPAL_INVESTIGATOR
References: