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Intervention to Change Attributions That Are Negative (ICAN)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03648476
Acronym
ICAN
Enrollment
28
Registered
2018-08-27
Start date
2018-11-02
Completion date
2021-01-11
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Anger, Aggression, Hostility

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).

Interventions

BEHAVIORALICAN

A 6-week group therapy sessions once a week for 90-120 minutes.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Buss-Perry Aggression Questionnaire ScoreChange from Baseline at Week 8 and Week 15The 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

MeasureTime frameDescription
Global Impression of Change for Perspective Taking and EmpathyWeek 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment)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. 1. No change (or condition has gotten worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better, and a definite improvement that has made a real and worthwhile difference 7. A great deal better, and a considerable improvement that has made all the difference
Change in Anger Affect ScoreChange from Week 1 at Week 8 and Week 15The 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 AggressionWeek 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment)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. 1. No change (or condition has gotten worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better, and a definite improvement that has made a real and worthwhile difference 7. A great deal better, and a considerable improvement that has made all the difference

Other

MeasureTime frameDescription
Change in Difficulty With Emotion Regulation Scale (DERS) ScoreChange from Week 1 at Week 8 and Week 15The 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 in The Ambiguous Intentions Hostility Questionnaire (AIHQ) ScoreChange from Baseline or Week 1(depending on when collected) at Week 8 and Week 15This 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 in Interpersonal Reactivity Index (IRI) - Perspective Taking and Empathic Concern ScoreChange from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15We 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 in Attributions of Hostility, Intent, Blame, and Anger (Epps Hypothetical Scenarios) ScoreChange from Baseline at Week 8 and Week 15Participants 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 in The Awareness of Social Inference Test (TASIT) ScoreChange from Baseline at Week 8 and Week 15The 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.

Countries

United States

Participant flow

Pre-assignment details

28 participants were enrolled (signed consent); however, 4 participants withdrew from the study PRIOR to randomization to the study arm.

Participants by arm

ArmCount
ICAN
6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing ICAN: A 6-week group therapy sessions once a week for 90-120 minutes.
10
WLC: Waitlist Control
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. ICAN: A 6-week group therapy sessions once a week for 90-120 minutes.
14
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicICANTotalWLC: Waitlist Control
Age, Continuous40.9 years
STANDARD_DEVIATION 10.7
42 years
STANDARD_DEVIATION 11.7
43.1 years
STANDARD_DEVIATION 12.7
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants23 Participants13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
9 Participants20 Participants11 Participants
Region of Enrollment
United States
10 Participants24 Participants14 Participants
Sex: Female, Male
Female
3 Participants7 Participants4 Participants
Sex: Female, Male
Male
7 Participants17 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 14
other
Total, other adverse events
12 / 247 / 14
serious
Total, serious adverse events
2 / 240 / 14

Outcome results

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.

Time frame: Change from Baseline at Week 8 and Week 15

Population: Week 8 is post-intervention for ICAN, where as WLC had not yet received the intervention. Only WLC subjects were tested at Week 15, and that is their post-test.

ArmMeasureGroupValue (MEAN)Dispersion
ICANChange in Buss-Perry Aggression Questionnaire ScoreChange from Baseline to Week 8-1.7 score on a scaleStandard Deviation 0.27
WLC: Waitlist ControlChange in Buss-Perry Aggression Questionnaire ScoreChange from Baseline to Week 8-5.91 score on a scaleStandard Deviation 3.6
WLC: Waitlist ControlChange in Buss-Perry Aggression Questionnaire ScoreChange from baseline to week 15-8.51 score on a scaleStandard Deviation 1.32
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.

Time frame: Change from Week 1 at Week 8 and Week 15

Population: Week 8 is post intervention for ICAN, but WLC will not have received the intervention.

ArmMeasureGroupValue (MEAN)Dispersion
ICANChange in Anger Affect ScoreChange from Baseline to Week 8-1.95 score on a scaleStandard Deviation 0.19
WLC: Waitlist ControlChange in Anger Affect ScoreChange from Baseline to Week 8-.89 score on a scaleStandard Deviation 2.17
WLC: Waitlist ControlChange in Anger Affect ScoreChange from Baseline to Week 15-4.49 score on a scaleStandard Deviation 1.63
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. 1. No change (or condition has gotten worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better, and a definite improvement that has made a real and worthwhile difference 7. 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)

Population: This assessment was sent to the participants electronically. There is missing data from one participant who was randomized to ICAN. All participants (ICAN and WLC) had received the intervention by the time this outcome assessment was administered.

ArmMeasureValue (MEDIAN)Dispersion
ICANGlobal Impression of Change for Anger and Aggression4 score on a scaleStandard Deviation 1.9
WLC: Waitlist ControlGlobal Impression of Change for Anger and Aggression4 score on a scaleStandard Deviation 1.98
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. 1. No change (or condition has gotten worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better, and a definite improvement that has made a real and worthwhile difference 7. 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)

Population: This assessment was sent to the participants electronically. There is missing data from several participants who did not return their survey after multiple attempts (ICAN missing data=1; WLC missing data=8). All participants (ICAN and WLC) had received the intervention by the time this outcome assessment was administered.

ArmMeasureValue (MEDIAN)Dispersion
ICANGlobal Impression of Change for Perspective Taking and Empathy5 score on a scaleStandard Deviation 1.15
WLC: Waitlist ControlGlobal Impression of Change for Perspective Taking and Empathy6 score on a scaleStandard Deviation 0.55
Other Pre-specified

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.

Time frame: Change from Baseline at Week 8 and Week 15

Other Pre-specified

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.

Time frame: Change from Week 1 at Week 8 and Week 15

Other Pre-specified

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

Time frame: Change from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15

Other Pre-specified

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).

Time frame: Change from Baseline or Week 1(depending on when collected) at Week 8 and Week 15

Other Pre-specified

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.

Time frame: Change from Baseline at Week 8 and Week 15

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026