Back to resultsIntervention to Change Attributions That Are Negative (ICAN) (ICAN)
Primary Purpose
Trauma, Brain, Brain Injuries, Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICAN
Sponsored by
About this trial
This is an interventional treatment trial for Trauma, Brain focused on measuring Anger, Aggression, Hostility
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
Sites / Locations
- The Rehabilitation Hospital of Indiana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ICAN
WLC: Waitlist Control
Arm Description
6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing
WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
Full Information
NCT ID
NCT03648476
First Posted
August 20, 2018
Last Updated
May 19, 2022
Sponsor
Indiana University
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03648476
Brief Title
Intervention to Change Attributions That Are Negative (ICAN)
Acronym
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
January 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Brain, Brain Injuries, Traumatic Brain Injury, Brain Injuries, Traumatic, Brain, Trauma
Keywords
Anger, Aggression, Hostility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICAN
Arm Type
Experimental
Arm Description
6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing
Arm Title
WLC: Waitlist Control
Arm Type
Other
Arm Description
WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions.
Intervention Type
Behavioral
Intervention Name(s)
ICAN
Intervention Description
A 6-week group therapy sessions once a week for 90-120 minutes.
Primary Outcome Measure Information:
Title
Change in Buss-Perry Aggression Questionnaire Score
Description
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.
Time Frame
Change from Baseline at Week 8 and Week 15
Secondary Outcome Measure Information:
Title
Change in Anger Affect Score
Description
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.
Time Frame
Change from Week 1 at Week 8 and Week 15
Title
Global Impression of Change for Anger and Aggression
Description
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
Time Frame
Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment)
Title
Global Impression of Change for Perspective Taking and Empathy
Description
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
Time Frame
Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment)
Other Pre-specified Outcome Measures:
Title
Change in Interpersonal Reactivity Index (IRI) - Perspective Taking and Empathic Concern Score
Description
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
Time Frame
Change from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15
Title
Change in Attributions of Hostility, Intent, Blame, and Anger (Epps Hypothetical Scenarios) Score
Description
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.
Time Frame
Change from Baseline at Week 8 and Week 15
Title
Change in The Awareness of Social Inference Test (TASIT) Score
Description
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.
Time Frame
Change from Baseline at Week 8 and Week 15
Title
Change in Difficulty With Emotion Regulation Scale (DERS) Score
Description
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.
Time Frame
Change from Week 1 at Week 8 and Week 15
Title
Change in The Ambiguous Intentions Hostility Questionnaire (AIHQ) Score
Description
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).
Time Frame
Change from Baseline or Week 1(depending on when collected) at Week 8 and Week 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Neumann, Phd
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
12. IPD Sharing Statement
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Intervention to Change Attributions That Are Negative (ICAN)
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