Anger Self-Management in Traumatic Brain Injury

NCT01745146 | Completed Results

• 2 other identifiers: R01 ASMT HN43851R01HD061400-01A2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

The present study addresses problematic anger and irritability in community dwelling persons with traumatic brain injury (TBI). It is designed to test the worth of a novel treatment approach called Anger Self-Management Training (ASMT), compared to a treatment offering supportive therapy focused on personal readjustment and education, the PRE (Personal Readjustment and Education). The project is a 3-center randomized controlled trial employing equivalent therapist time and therapeutic structure in the delivery of treatment options. The overall aim is to evaluate the relative response rate and correlates of treatment response for the ASMT as compared to the PRE.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; TBI; head injury; brain injury; Psych-educational treatment; Anger; irritability; anger management

Outcome Measures

Primary Outcomes (1)

• Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report

  Participant report only. The State-Trait Anger Expression Inventory-Revised Trait Anger Scale (STAXI-2 TA) measures how often angry feelings are experienced and the Anger Expression-Out (STAXI-2 AX-O) Scale addresses the expression of anger toward other persons or objects in the environment. The Brief Anger-Aggression Questionnaire (BAAQ) is a 6-item self-report scale that measures frequency of "acting-out" symptoms of anger. Overall treatment response is defined as ≥ 1 standard deviation change in the direction of improvement from pre- to 10 wk post-treatment on any 1 of the three anger scales used. Analysis first done by including participants who did not complete the assessment as non-responders (labeled as "missing outcomes included" or "MOI"). Analysis done a second time only using participants who completed the assessment (labeled as "missing outcomes removed" or "MOR").

  Baseline, 10 weeks (post-treatment)

Study Arms (2)

Anger Self-Management Training (ASMT)

EXPERIMENTAL

8-session, individual, psycho-educational intervention based on principles of self-monitoring and problem-solving training Significant other (friend or relative) invited to participate in 3 of 8 sessions

Behavioral: ASMT

Personal Readjustment and Ed (PRE)

ACTIVE COMPARATOR

8-session, individual, psycho-educational intervention based on principles of education and personal readjustment. Significant other (friend or relative) invited to participate in 3 of 8 sessions

Behavioral: PRE

Interventions

ASMT BEHAVIORAL

8-session, individual, psycho-educational intervention based on principles of self-monitoring and problem-solving training Significant other (friend or relative) invited to participate in 3 of 8 sessions

Anger Self-Management Training (ASMT)

PRE BEHAVIORAL

8-session, individual, psycho-educational intervention based on principles of education and personal readjustment to TBI Significant other (friend or relative) invited to participate in 3 of 8 sessions

Personal Readjustment and Ed (PRE)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 16 at the time of injury
• ages 18 to 65 at the time of enrollment
• TBI (closed or penetrating) occurring a minimum of 6 months prior to enrollment
• TBI documented as complicated mild, moderate, or severe TBI by any one or more of the following indices:
• post-resuscitation score on Glasgow Coma Scale (GCS) \< 13 or GCS Motor \< 6;
• loss of consciousness, unresponsiveness or coma attributable to the TBI and persisting ≥ 1 hour;
• post-traumatic amnesia, or disorientation (O x 0, 1 or 2) attributable to the TBI and persisting ≥ 24 hours; or
• neuro-imaging study positive for TBI-related findings such as contusion, hematoma, hemorrhage, diffuse axonal injury, shear injury, and/ or depressed skull fracture
• Able to travel independently in the community (to maximize the probability that participants will be cognitively and physically able to engage in the treatment)
• Indication from self or other report that participant has problematic anger/ irritability that is new since the injury or worse than before the injury
• Self-report of anger ≥ 1 standard deviation above the mean for age and gender on the Trait Anger or Anger Expression-Out (AX-O) subscales of the State-Trait Anger Expression Inventory-2 (STAXI-2), or a score of ≥ 7 on the Brief Anger-Aggression Questionnaire (BAAQ)
• Able to speak and understand English sufficiently to complete the screening and outcome measures and to participate in a verbally based treatment program, which thus far exists only in English
• Informed consent given by participant or legally authorized representative.

You may not qualify if:

• History of schizophrenia or schizo-affective disorder, as documented in medical records or by self-report that a medical professional has given the diagnosis
• Current psychosis, major depression, or suicidal ideation; or history of manic or hypomanic episode as determined by the Mini-International Neuropsychiatric Interview for DSM-IV (MINI) Current alcohol-l dependence, as determined by the MINI.
• Self-reported use of cocaine or amphetamines "daily" or "almost daily" using the relevant questions from the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
• TBI requiring hospitalization that has occurred within 6 months prior to enrollment
• Involvement in one-to-one counseling or psychotherapy targeted to emotional health issues
• Involvement in another treatment trial that may affect participation or outcomes
• Evidence of severe, intractable anger as indicated by history of violence-related crimes, e.g., charges for assault.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Craig Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Craig Hospital

Englewood, Colorado, 80237, United States

Location

Data Cordinating Center

Englewood, Colorado, 80237, United States

Location

Moss Rehabilitation Research Institue

Elkins Park, Pennsylvania, 19027, United States

Location

Related Publications (2)

• Hart T, Vaccaro MJ, Hays C, Maiuro RD. Anger self-management training for people with traumatic brain injury: a preliminary investigation. J Head Trauma Rehabil. 2012 Mar-Apr;27(2):113-22. doi: 10.1097/HTR.0b013e31820e686c.

  PMID: 21407088 BACKGROUND

• Hart T, Brockway JA, Maiuro RD, Vaccaro M, Fann JR, Mellick D, Harrison-Felix C, Barber J, Temkin N. Anger Self-Management Training for Chronic Moderate to Severe Traumatic Brain Injury: Results of a Randomized Controlled Trial. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):319-331. doi: 10.1097/HTR.0000000000000316.

  PMID: 28520666 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

All participants had self-reported problems with anger and were excluded for serious limitations in communication. Thus, the study cannot be generalized to those with very severe cognitive or communication deficits or who deny anger problems.

Results Point of Contact

• Title: Dr. Tessa Hart, PhD
• Organization: Moss Rehabilitation Research Institute

thart@einstein.edu

215-663-6153

Study Officials

• Tessa Hart, PhD

  Moss Rehabilitation Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Scientist, MRRI

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-10

Locations

US (3)