Intervention to Change Attributions That Are Negative (ICAN)

NCT ID: NCT03648476

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-02
• Study Completion Date: 2021-01-11

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ICAN

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

Group Type: EXPERIMENTAL

ICAN

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

ICAN

Intervention Type: BEHAVIORAL

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

Interventions

ICAN

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

Intervention Type: BEHAVIORAL

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Dawn Neumann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Neumann, Phd

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

The Rehabilitation Hospital of Indiana

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21HD094232-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1806829789

Identifier Type: -

Identifier Source: org_study_id