Intervention to Change Attributions That Are Negative (ICAN)

Not Applicable

Completed

• Conditions: Brain Injuries; Trauma, Brain; Traumatic Brain Injury; Brain, Trauma; Brain Injuries, Traumatic
• Interventions: Behavioral: ICAN

• Registration Number: NCT03648476
• Lead Sponsor: 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 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Study Start: 2018-11-02
• Primary Completion: 2020-11-23
• Study Completion: 2021-01-11
• Results First Submitted: 2021-07-27
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Results First Posted: 2022-05-23
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICAN	ICAN	6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing
WLC: Waitlist Control	ICAN	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.

Primary Outcome Measures

Name	Time	Method
Change in Buss-Perry Aggression Questionnaire Score	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.

Secondary Outcome Measures

Name	Time	Method
Global Impression of Change for Anger and Aggression	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.; 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
Global Impression of Change for Perspective Taking and Empathy	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.; 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 Score	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.

Trial Locations

Locations (1)

The Rehabilitation Hospital of Indiana; 🇺🇸 Indianapolis, Indiana, United States