Anger Self-Management in Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— ASMT  

Official title:

Anger Self-Management in Post-Acute Traumatic Brain Injury: Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745146
• Other study ID #: R01 ASMT HN4385
• Secondary ID: 1R01HD061400-01A
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2016

Study information

• Verified date: October 2018
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• ASMT
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
• PRE
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

Locations

Country	Name	City	State
United States	Moss Rehabilitation Research Institue	Elkins Park	Pennsylvania
United States	Craig Hospital	Englewood	Colorado
United States	Data Cordinating Center	Englewood	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network	Craig Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 201 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)