Anger Self-Management in Traumatic Brain Injury

Problematic anger/ irritability is common, persistent, and difficult to treat after TBI, and
has a broad impact on community and social function. Anger following TBI is related, in part,
to deficits in executive function including impaired problem-solving and impaired
self-monitoring. In this 2-group, 3-center clinical trial with masked outcome assessment, we
will explore feasibility and efficacy of a manualized, 8-session individual treatment, Anger
Self-Management Training (ASMT), compared to a treatment using non-specific ingredients of
therapist attention, education, and psychological support (PRE).

The ASMT was designed to decrease subjective and objective anger and irritability following
traumatic brain injury (TBI), using theoretically motivated "active ingredients." The ASMT
focuses on 2 executive deficits implicated in anger post TBI, (1) self-awareness and
self-monitoring and (2) problem-solving. Participants will be randomly assigned in 2:1
proportion to ASMT or PRE. The PRE treatment is manualized to the same degree as the ASMT,
but focuses on educational and personal readjustment to injury rather than anger-specific
strategy training.

The overall goals are to examine the effects of the ASMT compared to PRE on self-reported
problematic anger, both 1 week and 2 months after treatment, and to assess the time course of
treatment response during the treatment phase.

Specific Aims

1. To examine the efficacy of ASMT compared to a control treatment (PRE) as measured by
improvement from baseline to post-treatment on the State-Trait Anger Expression
Inventory-Revised (STAXI-2) Trait Anger; STAXI-2 Anger Expression-Out; or the Brief
Anger-Aggression Questionnaire (BAAQ) (primary outcome).

2. To examine the trajectory of treatment response within the treatment phase of ASMT/ PRE
as shown by a change on 1 or more of the target scales halfway through the treatment
(i.e., after 4 of 8 sessions) for those participants who exhibited a positive response
post treatment (as defined above).

3. To examine the persistence of treatment effects 2 months after the end of the treatment
phase.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.