- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648476
Intervention to Change Attributions That Are Negative (ICAN) (ICAN)
Intervention to Change Attributions That Are Negative (ICAN): a New Approach to Reducing Anger and Aggression After Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46254
- The Rehabilitation Hospital of Indiana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ICAN
6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing
|
A 6-week group therapy sessions once a week for 90-120 minutes.
|
Other: 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.
|
A 6-week group therapy sessions once a week for 90-120 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Buss-Perry Aggression Questionnaire Score
Time Frame: Change from Baseline at Week 8 and Week 15
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Anger Affect Score
Time Frame: Change from Week 1 at Week 8 and Week 15
|
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
|
Global Impression of Change for Anger and Aggression
Time Frame: Week 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.
|
Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment)
|
Global Impression of Change for Perspective Taking and Empathy
Time Frame: Week 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.
|
Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Interpersonal Reactivity Index (IRI) - Perspective Taking and Empathic Concern Score
Time Frame: Change from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15
|
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
|
Change in Attributions of Hostility, Intent, Blame, and Anger (Epps Hypothetical Scenarios) Score
Time Frame: Change from Baseline at Week 8 and Week 15
|
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
|
Change in The Awareness of Social Inference Test (TASIT) Score
Time Frame: Change from Baseline at Week 8 and Week 15
|
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
|
Change in Difficulty With Emotion Regulation Scale (DERS) Score
Time Frame: Change from Week 1 at Week 8 and Week 15
|
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
|
Change in The Ambiguous Intentions Hostility Questionnaire (AIHQ) Score
Time Frame: Change from Baseline or Week 1(depending on when collected) at Week 8 and Week 15
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dawn Neumann, Phd, Indiana University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1806829789
- 1R21HD094232-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Injuries
-
Eunice Kennedy Shriver National Institute of Child...CompletedTraumatic Brain Injuries
-
Technical University of MunichFederal Ministry of Defence (Germany); Bundesministerium der VerteidigungRecruitingTraumatic Brain InjuriesFrance, Germany
-
University of Colorado, DenverBinghamton University; Brooke Army Medical CenterRecruitingBrain ConcussionUnited States
-
University of Alabama at BirminghamCompletedTraumatic Brain InjuriesUnited States
-
More FoundationElMindA Ltd; Riddell, LLC; Mimic SystemsUnknownAthletic Injuries | Concussion, BrainUnited States
-
Mosaic Life CareMissouri Western State UniversityTerminatedBrain Injuries | Brain Concussion | Athletic Injuries | Diffuse Axonal Injury | Injury, Brain, TraumaticUnited States
-
Bayside HealthVictorian Trauma FoundationCompletedTraumatic Brain Injury | Multiple Trauma | Spinal InjuriesAustralia
-
La Trobe UniversityRecruitingAnterior Cruciate Ligament Injuries | Concussion, Brain | Musculoskeletal InjuryAustralia
-
Association de Recherche Bibliographique pour les...University of Cambridge; Centre Hospitalier Princesse Grace; Institut National...CompletedBrain Injuries | Sport Injury | Concussion, BrainMonaco
-
CentraCareElectroCore INCCompletedTraumatic Brain Injury | Acute Brain InjuriesUnited States
Clinical Trials on ICAN
-
Southcentral FoundationWashington State UniversityRecruitingHypertensionUnited States
-
University of Texas at AustinUniversity of Maryland; Agency for Healthcare Research and Quality (AHRQ); Sunrise...RecruitingMedication Adherence | Social Support | Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness | Pyschological Distress | Attainment of Social Needs (i.e., Housing, Employment, Receipt of Benefits)United States
-
Mary CharltonNational Cancer Institute (NCI)Active, not recruiting
-
University of CincinnatiNot yet recruitingDiabetes Mellitus, Type 2 | PreDiabetesUnited States
-
Florida State UniversityRecruitingAlzheimer Disease | Mild Cognitive ImpairmentUnited States