Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, TBI, head injury, brain injury, Psych-educational treatment, Anger, irritability, anger management
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.
Interventions
BEHAVIORALASMT
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
BEHAVIORALPRE
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
Sponsors
Craig Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Albert Einstein Healthcare Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | Baseline, 10 weeks (post-treatment) | 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). |
Countries
United States
Participant flow
Pre-assignment details
After consent and T1 assessment, participants were randomized (2:1 Anger Self-Management Training or Personal Readjustment and Education) using a computer-generated table provided by the study's Data Coordinating Center, and assigned to the therapist corresponding to their treatment condition. Participants stratified by site.
Participants by arm
| Arm | Count |
|---|---|
| Personal Readjustment and Education (PRE) Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles. | 30 |
| Anger Self-Management Training (ASMT) Participants provided with education emphasizing the teaching of behavioral skills (self-monitoring, problem-solving) in addition to focused education about anger and its links to traumatic brain injury (TBI). | 60 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Personal Readjustment and Education (PRE) | Total | Anger Self-Management Training (ASMT) |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 13.3 | 32.1 years STANDARD_DEVIATION 11.5 | 30.4 years STANDARD_DEVIATION 10.2 |
| Cause of Injury Fall | 6 Participants | 14 Participants | 8 Participants |
| Cause of Injury Intentional Injury | 5 Participants | 12 Participants | 7 Participants |
| Cause of Injury Other | 2 Participants | 9 Participants | 7 Participants |
| Cause of Injury Vehicular Incident | 17 Participants | 55 Participants | 38 Participants |
| Education | 13.4 years STANDARD_DEVIATION 2.5 | 13.4 years STANDARD_DEVIATION 2.2 | 13.4 years STANDARD_DEVIATION 2.1 |
| Median PTA Duration 15 - 30 days | 9 Participants | 27 Participants | 18 Participants |
| Median PTA Duration < 15 days | 7 Participants | 22 Participants | 15 Participants |
| Median PTA Duration 31 - 90 days | 11 Participants | 26 Participants | 15 Participants |
| Median PTA Duration > 90 days | 3 Participants | 15 Participants | 12 Participants |
| Median Time Post Injury | 72 Months | 71 Months | 69 Months |
| Neuropsychological Status Brixton Spatial Anticipation Test: Error Score | 19.3 units on a scale STANDARD_DEVIATION 6.7 | 17.91 units on a scale STANDARD_DEVIATION 7.39 | 17.2 units on a scale STANDARD_DEVIATION 7.7 |
| Neuropsychological Status BSI GSI | 66.7 units on a scale STANDARD_DEVIATION 10.3 | 68.2 units on a scale STANDARD_DEVIATION 8.84 | 68.9 units on a scale STANDARD_DEVIATION 8 |
| Neuropsychological Status FrSBe Self-Report | 64.4 units on a scale STANDARD_DEVIATION 17.4 | 63.08 units on a scale STANDARD_DEVIATION 16.2 | 62.4 units on a scale STANDARD_DEVIATION 15.7 |
| Neuropsychological Status GOS-E | 5.6 units on a scale STANDARD_DEVIATION 0.9 | 5.87 units on a scale STANDARD_DEVIATION 0.96 | 6 units on a scale STANDARD_DEVIATION 1 |
| Neuropsychological Status IQ Determined from WASI | 94 units on a scale STANDARD_DEVIATION 16.3 | 95.97 units on a scale STANDARD_DEVIATION 16.13 | 97 units on a scale STANDARD_DEVIATION 16.1 |
| Neuropsychological Status RAVLT: Sum 5 Trials | 37.8 units on a scale STANDARD_DEVIATION 9.5 | 39.43 units on a scale STANDARD_DEVIATION 10.9 | 40.3 units on a scale STANDARD_DEVIATION 11.5 |
| Neuropsychological Status Trail Making Test Part B: T-Score | 40 units on a scale STANDARD_DEVIATION 15.2 | 40.81 units on a scale STANDARD_DEVIATION 13.71 | 41.2 units on a scale STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 21 Participants | 13 Participants |
| Race/Ethnicity, Customized Hispanic or Other | 0 Participants | 7 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 62 Participants | 40 Participants |
| Sex: Female, Male Female | 6 Participants | 17 Participants | 11 Participants |
| Sex: Female, Male Male | 24 Participants | 73 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 60 |
| other Total, other adverse events | 9 / 30 | 2 / 60 |
| serious Total, serious adverse events | 2 / 30 | 7 / 60 |
Outcome results
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).
Time frame: Baseline, 10 weeks (post-treatment)
Population: Missing outcomes originally treated as non-Responders (Protocol Specified) and then taken out of data set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Personal Readjustment and Education (PRE) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 TA (MOI) | 46.7 percentage of participants |
| Personal Readjustment and Education (PRE) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 AX-O (MOI) | 50.0 percentage of participants |
| Personal Readjustment and Education (PRE) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | BAAQ (MOI) | 16.7 percentage of participants |
| Personal Readjustment and Education (PRE) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | Overall (MOI) | 63.3 percentage of participants |
| Personal Readjustment and Education (PRE) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 TA (MOR) | 51.9 percentage of participants |
| Personal Readjustment and Education (PRE) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 AX-O (MOR) | 55.6 percentage of participants |
| Personal Readjustment and Education (PRE) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | BAAQ (MOR) | 18.5 percentage of participants |
| Personal Readjustment and Education (PRE) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | Overall (MOR) | 70.4 percentage of participants |
| Anger Self-Management Training (ASMT) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | BAAQ (MOI) | 11.7 percentage of participants |
| Anger Self-Management Training (ASMT) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | BAAQ (MOR) | 12.3 percentage of participants |
| Anger Self-Management Training (ASMT) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | Overall (MOI) | 71.1 percentage of participants |
| Anger Self-Management Training (ASMT) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 TA (MOR) | 71.9 percentage of participants |
| Anger Self-Management Training (ASMT) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 AX-O (MOR) | 59.6 percentage of participants |
| Anger Self-Management Training (ASMT) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 TA (MOI) | 68.3 percentage of participants |
| Anger Self-Management Training (ASMT) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 AX-O (MOI) | 56.7 percentage of participants |
| Anger Self-Management Training (ASMT) | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | Overall (MOR) | 75.4 percentage of participants |
| Difference | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | BAAQ (MOI) | -5.0 percentage of participants |
| Difference | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 AX-O (MOI) | 6.7 percentage of participants |
| Difference | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 TA (MOI) | 21.7 percentage of participants |
| Difference | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | Overall (MOI) | 8.3 percentage of participants |
| Difference | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | BAAQ (MOR) | -6.2 percentage of participants |
| Difference | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 AX-O (MOR) | 4.1 percentage of participants |
| Difference | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | STAXI-2 TA (MOR) | 20.1 percentage of participants |
| Difference | Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report | Overall (MOR) | 5.1 percentage of participants |
Comparison: Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes reported at non-responders.p-value: 0.047Chi-squared
Comparison: Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes reported at non-responders.p-value: 0.549Chi-squared
Comparison: Significance of difference in post-treatment response rate for BAAQ. Missing outcomes reported at non-responders.p-value: 0.511Chi-squared
Comparison: Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes excluded for this analysis.p-value: 0.031Chi-squared
Comparison: Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes excluded for this analysis.p-value: 0.483Chi-squared
Comparison: Significance of difference in post-treatment response rate for BAAQ. Missing outcomes excluded for this analysis.p-value: 0.53Chi-squared
Comparison: Significance of difference in overall post-treatment response rate. Missing outcomes included as non-responders.p-value: 0.421Chi-squared
Comparison: Significance of difference in overall post-treatment response rate. Missing outcomes excluded for this analysis.p-value: 0.332Chi-squared