Clinical trial NCT01745146: Anger Self-Management in Traumatic Brain Injury
Official title: Anger Self-Management in Post-Acute Traumatic Brain Injury: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
TBI
head injury
brain injury
Psych-educational treatment
Anger
irritability
anger management
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: Craig Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-12-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
timeFrame: Baseline, 10 weeks (post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: Englewood
country: United States
facility: Data Cordinating Center
state: Colorado
city: Elkins Park
country: United States
facility: Moss Rehabilitation Research Institue
state: Pennsylvania
Study officials:
affiliation: Moss Rehabilitation Research Institute
name: Tessa Hart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.