Trial Outcomes & Findings for Anger Self-Management in Traumatic Brain Injury (NCT NCT01745146)
NCT ID: NCT01745146
Last Updated: 2018-10-19
Results Overview
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").
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Baseline, 10 weeks (post-treatment)
Results posted on
2018-10-19
Participant Flow
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.
Participant milestones
| Measure |
Personal Readjustment and Education (PRE)
Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
60
|
|
Overall Study
Allocation to Intervention
|
30
|
60
|
|
Overall Study
Primary Outcome Assessment
|
27
|
57
|
|
Overall Study
Analysis
|
27
|
57
|
|
Overall Study
COMPLETED
|
27
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Personal Readjustment and Education (PRE)
Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
|
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Anger Self-Management in Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Personal Readjustment and Education (PRE)
n=30 Participants
Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
|
Anger Self-Management Training (ASMT)
n=60 Participants
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).
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 13.3 • n=93 Participants
|
30.4 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
32.1 years
STANDARD_DEVIATION 11.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Other
|
0 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Education
|
13.4 years
STANDARD_DEVIATION 2.5 • n=93 Participants
|
13.4 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
13.4 years
STANDARD_DEVIATION 2.2 • n=27 Participants
|
|
Cause of Injury
Vehicular Incident
|
17 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Cause of Injury
Fall
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Cause of Injury
Intentional Injury
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Cause of Injury
Other
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Median PTA Duration
< 15 days
|
7 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Median PTA Duration
15 - 30 days
|
9 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Median PTA Duration
31 - 90 days
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Median PTA Duration
> 90 days
|
3 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Neuropsychological Status
IQ Determined from WASI
|
94 units on a scale
STANDARD_DEVIATION 16.3 • n=93 Participants
|
97 units on a scale
STANDARD_DEVIATION 16.1 • n=4 Participants
|
95.97 units on a scale
STANDARD_DEVIATION 16.13 • n=27 Participants
|
|
Neuropsychological Status
RAVLT: Sum 5 Trials
|
37.8 units on a scale
STANDARD_DEVIATION 9.5 • n=93 Participants
|
40.3 units on a scale
STANDARD_DEVIATION 11.5 • n=4 Participants
|
39.43 units on a scale
STANDARD_DEVIATION 10.9 • n=27 Participants
|
|
Neuropsychological Status
Brixton Spatial Anticipation Test: Error Score
|
19.3 units on a scale
STANDARD_DEVIATION 6.7 • n=93 Participants
|
17.2 units on a scale
STANDARD_DEVIATION 7.7 • n=4 Participants
|
17.91 units on a scale
STANDARD_DEVIATION 7.39 • n=27 Participants
|
|
Neuropsychological Status
Trail Making Test Part B: T-Score
|
40 units on a scale
STANDARD_DEVIATION 15.2 • n=93 Participants
|
41.2 units on a scale
STANDARD_DEVIATION 13 • n=4 Participants
|
40.81 units on a scale
STANDARD_DEVIATION 13.71 • n=27 Participants
|
|
Neuropsychological Status
GOS-E
|
5.6 units on a scale
STANDARD_DEVIATION 0.9 • n=93 Participants
|
6 units on a scale
STANDARD_DEVIATION 1 • n=4 Participants
|
5.87 units on a scale
STANDARD_DEVIATION 0.96 • n=27 Participants
|
|
Neuropsychological Status
BSI GSI
|
66.7 units on a scale
STANDARD_DEVIATION 10.3 • n=93 Participants
|
68.9 units on a scale
STANDARD_DEVIATION 8.0 • n=4 Participants
|
68.2 units on a scale
STANDARD_DEVIATION 8.84 • n=27 Participants
|
|
Neuropsychological Status
FrSBe Self-Report
|
64.4 units on a scale
STANDARD_DEVIATION 17.4 • n=93 Participants
|
62.4 units on a scale
STANDARD_DEVIATION 15.7 • n=4 Participants
|
63.08 units on a scale
STANDARD_DEVIATION 16.2 • n=27 Participants
|
|
Median Time Post Injury
|
72 Months
n=93 Participants
|
69 Months
n=4 Participants
|
71 Months
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 10 weeks (post-treatment)Population: Missing outcomes originally treated as non-Responders (Protocol Specified) and then taken out of data set.
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").
Outcome measures
| Measure |
Personal Readjustment and Education (PRE)
n=30 Participants
Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
|
Anger Self-Management Training (ASMT)
n=60 Participants
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).
|
Difference
n=90 Participants
The difference in treatment response rates between the ASMT group and the PRE group.
|
|---|---|---|---|
|
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
STAXI-2 AX-O (MOR)
|
55.6 percentage of participants
Interval 36.9 to 74.3
|
59.6 percentage of participants
Interval 46.9 to 72.3
|
4.1 percentage of participants
Interval -17.5 to 26.3
|
|
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
STAXI-2 TA (MOI)
|
46.7 percentage of participants
Interval 28.9 to 64.6
|
68.3 percentage of participants
Interval 56.5 to 80.1
|
21.7 percentage of participants
Interval 0.3 to 41.8
|
|
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
STAXI-2 AX-O (MOI)
|
50.0 percentage of participants
Interval 32.1 to 68.0
|
56.7 percentage of participants
Interval 44.2 to 69.2
|
6.7 percentage of participants
Interval -14.6 to 27.7
|
|
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
BAAQ (MOI)
|
16.7 percentage of participants
Interval 3.4 to 30.0
|
11.7 percentage of participants
Interval 3.2 to 19.1
|
-5.0 percentage of participants
Interval -22.2 to 8.4
|
|
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
Overall (MOI)
|
63.3 percentage of participants
Interval 46.0 to 80.1
|
71.1 percentage of participants
Interval 60.3 to 83.1
|
8.3 percentage of participants
Interval -11.1 to 29.0
|
|
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
STAXI-2 TA (MOR)
|
51.9 percentage of participants
Interval 33.0 to 70.8
|
71.9 percentage of participants
Interval 60.2 to 83.6
|
20.1 percentage of participants
Interval -1.6 to 41.2
|
|
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
BAAQ (MOR)
|
18.5 percentage of participants
Interval 3.8 to 33.1
|
12.3 percentage of participants
Interval 3.8 to 20.8
|
-6.2 percentage of participants
Interval -24.8 to 8.2
|
|
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
Overall (MOR)
|
70.4 percentage of participants
Interval 53.2 to 87.6
|
75.4 percentage of participants
Interval 64.2 to 86.6
|
5.1 percentage of participants
Interval -13.5 to 26.3
|
Adverse Events
Personal Readjustment and Education (PRE)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Anger Self-Management Training (ASMT)
Serious events: 7 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Personal Readjustment and Education (PRE)
n=30 participants at risk
Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
|
Anger Self-Management Training (ASMT)
n=60 participants at risk
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).
|
|---|---|---|
|
Surgical and medical procedures
Admission to Hospital or Overnight Treatment Facility
|
6.7%
2/30 • Number of events 2 • Adverse event data were monitored from the first treatment session to the final outcome evaluation. This consisted of a monitoring period of 4 months per study participant. Adverse events (AE) and serious adverse events (SAE) were queried with a checklist at each data collection episode and each therapy session through study completion (4 months altogether). If endorsed, events were evaluated as to seriousness, duration, resolution date if any, and possible relationship to study procedures.
For SAEs, we adhered to a standard definition used in medical trials: any event for which the outcome is death, hospitalization, life-threatening (i.e., person is at risk of death at the time of the event) or the event leads to disability and/or incapacity, or requires intervention to prevent those outcomes. We defined AEs as self-reported emergency care visits, arrests, episodes of violence, thoughts of harming self or others and withdrawal from therapy sessions and/or from the study at large.
|
11.7%
7/60 • Number of events 7 • Adverse event data were monitored from the first treatment session to the final outcome evaluation. This consisted of a monitoring period of 4 months per study participant. Adverse events (AE) and serious adverse events (SAE) were queried with a checklist at each data collection episode and each therapy session through study completion (4 months altogether). If endorsed, events were evaluated as to seriousness, duration, resolution date if any, and possible relationship to study procedures.
For SAEs, we adhered to a standard definition used in medical trials: any event for which the outcome is death, hospitalization, life-threatening (i.e., person is at risk of death at the time of the event) or the event leads to disability and/or incapacity, or requires intervention to prevent those outcomes. We defined AEs as self-reported emergency care visits, arrests, episodes of violence, thoughts of harming self or others and withdrawal from therapy sessions and/or from the study at large.
|
Other adverse events
| Measure |
Personal Readjustment and Education (PRE)
n=30 participants at risk
Participants provided with education about the effects of traumatic brain injury (TBI) on personal characteristics, relationships, and community roles.
|
Anger Self-Management Training (ASMT)
n=60 participants at risk
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).
|
|---|---|---|
|
Psychiatric disorders
Episode of rage
|
30.0%
9/30 • Number of events 9 • Adverse event data were monitored from the first treatment session to the final outcome evaluation. This consisted of a monitoring period of 4 months per study participant. Adverse events (AE) and serious adverse events (SAE) were queried with a checklist at each data collection episode and each therapy session through study completion (4 months altogether). If endorsed, events were evaluated as to seriousness, duration, resolution date if any, and possible relationship to study procedures.
For SAEs, we adhered to a standard definition used in medical trials: any event for which the outcome is death, hospitalization, life-threatening (i.e., person is at risk of death at the time of the event) or the event leads to disability and/or incapacity, or requires intervention to prevent those outcomes. We defined AEs as self-reported emergency care visits, arrests, episodes of violence, thoughts of harming self or others and withdrawal from therapy sessions and/or from the study at large.
|
3.3%
2/60 • Number of events 2 • Adverse event data were monitored from the first treatment session to the final outcome evaluation. This consisted of a monitoring period of 4 months per study participant. Adverse events (AE) and serious adverse events (SAE) were queried with a checklist at each data collection episode and each therapy session through study completion (4 months altogether). If endorsed, events were evaluated as to seriousness, duration, resolution date if any, and possible relationship to study procedures.
For SAEs, we adhered to a standard definition used in medical trials: any event for which the outcome is death, hospitalization, life-threatening (i.e., person is at risk of death at the time of the event) or the event leads to disability and/or incapacity, or requires intervention to prevent those outcomes. We defined AEs as self-reported emergency care visits, arrests, episodes of violence, thoughts of harming self or others and withdrawal from therapy sessions and/or from the study at large.
|
Additional Information
Dr. Tessa Hart, PhD
Moss Rehabilitation Research Institute
Phone: 215-663-6153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place