Anger Self-Management in Traumatic Brain Injury

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID: NCT01745146
Run by: Albert Einstein Healthcare Network
People needed: 90
Starts: 2012-09-01
Expected to finish: 2016-09-01
Last updated by the study team: 2018-10-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Craig Hospital — Englewood, Colorado, United States
Data Cordinating Center — Englewood, Colorado, United States
Moss Rehabilitation Research Institue — Elkins Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.