Intervention to Change Attributions That Are Negative (ICAN)

Traumatic Brain Injury Clinical Trial

— ICAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648476
• Other study ID #: 1806829789
• Secondary ID: 1R21HD094232-01
• Status: Completed
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: January 11, 2021

Study information

• Verified date: May 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 11, 2021
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain, Trauma
• Trauma, Brain
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• ICAN
A 6-week group therapy sessions once a week for 90-120 minutes.

Locations

Country	Name	City	State
United States	The Rehabilitation Hospital of Indiana	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Interpersonal Reactivity Index (IRI) - Perspective Taking and Empathic Concern Score	We will use 2 subscales from the Interpersonal Reactivity Index: Perspective-taking and Empathic Concern. It is a standardized, subjective measure that uses a 5 point scale. There are 7 questions for each subscale.; Scale (0,1,2,3,4). Scores are calculated each subscale Perspective scale scores range from 0-28 Empathic concern scores range from 0-28 Higher scores indicate more perspective taking and empathy	Change from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15
Other	Change in Attributions of Hostility, Intent, Blame, and Anger (Epps Hypothetical Scenarios) Score	Participants are presented with 21 hypothetical scenarios are 21. After each scenario, participants rate attributions of intent, hostility, and blame, as well as how angry they would be in response to the scenario using a 9-point Likert scale. Scores are calculated for attributions of intent; 2) attributions of hostility; 3) attributions of blame; 4) and anger responses.; Rating Scale:1,2,3,4,5,6,7,8,9 Scores are calculated for each attribution (intent, hostility, blame) and anger response) Separate average scores are calculated for attributions of intent, hostility, blame and ange.; Average scores for each range from 1-9. Higher scores indicate more negative attributions or anger.	Change from Baseline at Week 8 and Week 15
Other	Change in The Awareness of Social Inference Test (TASIT) Score	The Awareness of Social Inference Test (TASIT) is a performance-based measure that uses short one minute video vignettes to assess emotion recognition and social inferences. Participants' responses are scored as right or wrong. Each correct response earns 1 points. Below are the three subtests that comprise the TASIT. Correct responses are tallied as total scores.; Part I: Emotion Perception. 28 items. Score ranges from 0-28. Higher score is better performance.; Part 2: Social inference (minimal context- not much context available to make inference of sincere and sarcastic exchanges). 15 items. Scores range from 0-15. Higher score is better performance.; Part 3: Social Inference (Enriched context - more context available to make inference of sarcasm and lies). 16 items. Scores range from 0-16. Higher score is better performance.	Change from Baseline at Week 8 and Week 15
Other	Change in Difficulty With Emotion Regulation Scale (DERS) Score	The Difficulty with Emotion Regulation Scale (DERS) is a 5-point Likert scale that participants use to rate the frequency they utilize self-regulation behaviors in response to general emotional distress.; Total scores indicate emotion dysregulation or problems with regulating emotions. There are 6 subscales. Subscale scores are summed to generate a total emotion dysregulation score.; Likert scale (1, 2, 3, 4, 5). Total Raw scores range from 36-180. Higher scores indicate more emotion regulation problems (worse outcome) Subscales are summed to compute a Total Emotion dysregulation raw score.	Change from Week 1 at Week 8 and Week 15
Other	Change in The Ambiguous Intentions Hostility Questionnaire (AIHQ) Score	This questionnaire consists of 15 written vignettes describing actions/ situations that were intentional (5), am-biguous (5) and accidental (5). After participants read each vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other person (or persons) acted that way toward you (open-ended response later rated by two independent raters; score indicates ''hostility bias''); 2) Whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes'') using a Likert Scale (Intent score); 3) how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry'') using a Likert scale (anger score); 4) how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much'') using a Likert scale (blame score); and 5) how she or he would respond to the situation, (open-ended re-sponse).	Change from Baseline or Week 1(depending on when collected) at Week 8 and Week 15
Primary	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	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
Secondary	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)
Secondary	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)