Intervention to Change Attributions That Are Negative (ICAN)

NCT03648476 | Completed Results

• 2 other identifiers: 18068297891R21HD094232-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anger; Aggression; Hostility

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline at Week 8 and Week 15

Secondary Outcomes (3)

• Change in Anger Affect Score

  Change from Week 1 at Week 8 and Week 15

• 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)

• 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)

Other Outcomes (5)

• Change in Interpersonal Reactivity Index (IRI) - Perspective Taking and Empathic Concern Score

  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

  Change from Baseline at Week 8 and Week 15

• Change in The Awareness of Social Inference Test (TASIT) Score

  Change from Baseline at Week 8 and Week 15

Study Arms (2)

ICAN

EXPERIMENTAL

6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing

Behavioral: ICAN

WLC: Waitlist Control

OTHER

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

Interventions

ICAN BEHAVIORAL

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

ICAN; WLC: Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries; Aggression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Results Point of Contact

• Title: Dawn Neumann
• Organization: Indiana University

dmneuman@iupui.edu

3173292188

Study Officials

• Dawn Neumann, Phd

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 27, 2018
• Study Start: November 2, 2018
• Primary Completion: November 23, 2020
• Study Completion: January 11, 2021
• Last Updated: May 23, 2022
• Results First Posted: May 23, 2022

Record last verified: 2022-05

Locations

US (1)