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Intervention to Change Attributions That Are Negative (ICAN) (ICAN)

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ClinicalTrials.gov Identifier: NCT03648476
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Dawn Neumann, Indiana University

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 15 weeks and the intervention is 6 weeks long.

Condition or disease Intervention/treatment Phase
Trauma, Brain Brain Injuries Traumatic Brain Injury Brain Injuries, Traumatic Brain, Trauma Behavioral: ICAN Not Applicable

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; Posttest I (post-treatment for ICAN; post-wait period for WLC); Posttest II (WLC post-treatment).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention to Change Attributions That Are Negative (ICAN): a New Approach to Reducing Anger and Aggression After Brain Injury
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2021

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

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




Primary Outcome Measures :
  1. Change in Buss-Perry Aggression Questionnaire Score [ Time Frame: Week 0, Week 1, Week 8, 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).

    Total Raw Aggression scores range from 34-170. Subscales are summed to compute a Total Aggression raw score. Higher scores indicate higher aggression Total Aggressions Scores are converted to T scores (1-100).



Secondary Outcome Measures :
  1. Change in Anger Affect [ Time Frame: Week 0, Week 1, Week 8, Week 15 ]

    The Anger-Affect Scale, from the NIH Emotion Toolbox, 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. Scores are converted to standard scores, with higher scores indicating greater anger severity.


  2. Global Impression of Change for Anger and Aggression [ Time Frame: Week 8 ]

    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"). This measure will be administered to patient participants and their caregivers.

    Total Raw scores range from 1-7. Higher scores indicate greater change.


  3. Global Impression of Change for Perspective taking and Empathy [ Time Frame: Week 8 ]

    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"). This measure will be administered to patient participants and their caregivers.

    Total Raw scores range from 1-7. Higher scores indicate greater change.



Other Outcome Measures:
  1. Change in Interpersonal Reactivity Index (IRI)- Perspective Taking and Empathic Concern [ Time Frame: Time 1 Visit,Time 2 Visit, and Time 3 Visit (Waitlist Control Only) ]

    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


  2. Change in Attributions of hostility. intent, blame, and anger (Epps Hypothetical scenarios) [ Time Frame: Week 0, Week 1, Week 8, 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.


  3. Change in The Awareness of Social Inference Test (TASIT) [ Time Frame: Week 0, Week 1, Week 8, 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.


  4. Change in Difficulty with Emotion Regulation Scale (DERS) [ Time Frame: Week 0, Week 1, Week 8, 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 negative attribution bias (above average attribution ratings for intent or hostility, which will be de-termined during screening).
  • Have above average aggression (prescreened on telephone, and confirmed T0 screening).
  • No anticipated medication changes for emotions/ behavior during length of study participation; medica-tions 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)
  • Progressive central nervous system disorders (e.g. dementia, Parkinson's)
  • Developmental disability (e.g., autism, developmental delay);
  • Major psychiatric disorders (e.g. schizophrenia, Bipolar Disorder, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648476


Contacts
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Contact: Kelsey Hurm, MS 3173292044 khurm@iu.edu

Locations
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United States, Indiana
The Rehabilitation Hospital of Indiana Recruiting
Indianapolis, Indiana, United States, 46254
Contact: Kelsey Hurm, MS    317-329-2044    khurm@iu.edu   
Sponsors and Collaborators
Indiana University
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Dawn Neumann, Phd Indiana University School of Medicine

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Responsible Party: Dawn Neumann, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT03648476     History of Changes
Other Study ID Numbers: 1806829789
1R21HD094232-01 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dawn Neumann, Indiana University:
Anger
Aggression
Hostility

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System