Trial Outcomes & Findings for Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans (NCT NCT02157779)

Last Updated: 2021-11-18

Results Overview

The STAXI-2 is a revision of Spielberger's State-Trait Anger Expression Inventory (STAXI), expanded from 44 to 57 items. It is a self-report questionnaire consisting of six scales and an Anger Expression Index (AX). Scales include State Anger, Trait Anger, Anger Expression-Out, Anger Expression-In, Anger Control-Out and Anger Expression-In. The Anger Expression Index is an overall measure of the expression and control of anger based on responses to the two anger expression and the two anger control subscales. Minimum and Maximum Values range from 0 to 96, higher scores mean more anger.

Recruitment status

COMPLETED

Study phase

Target enrollment

112 participants

Primary outcome timeframe

Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment

Results posted on

2021-11-18

Participant Flow

Participants were recruited from a wide range of sources during the time period of January 1, 2015 through January 31, 2018. The primary recruitment source was the Providence Veterans Affairs Medical Center, including the OEF/OIF specialty primary care clinic, the Returning Veterans Outreach Program (REVOC) and the PTSD Clinic.

Of the 112 enrolled, 94 completed both the first and second baseline assessments and were deemed eligible for the study. Of the 94 who completed their second baseline and were deemed eligible for the study, 92 were randomized to treatment. Two of the 92 randomized participants did not respond to outreach and did not start treatment.

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Intervention 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Overall Study STARTED	47	45
Overall Study COMPLETED	23	34
Overall Study NOT COMPLETED	24	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitive Behavioral Intervention 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Overall Study Logistical	9	3
Overall Study Stopped attending, reason unknown	11	7
Overall Study No response to outreach after Baseline	1	1
Overall Study Moved	1	0
Overall Study Medical	1	0
Overall Study Legal issue	1	0

Baseline Characteristics

Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Intervention n=47 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention n=45 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.	Total n=92 Participants Total of all reporting groups
Age, Continuous	35.30 years STANDARD_DEVIATION 9.11 • n=5 Participants	36.5 years STANDARD_DEVIATION 9.77 • n=7 Participants	35.90 years STANDARD_DEVIATION 9.41 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	43 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	33 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	35 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Employment Status Full Time	22 Participants n=5 Participants	27 Participants n=7 Participants	49 Participants n=5 Participants
Employment Status Part Time	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Employment Status Unemployed	14 Participants n=5 Participants	3 Participants n=7 Participants	17 Participants n=5 Participants
Employment Status Retired	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Education High School Graduate/GED	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Education Some College/Technical School	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Education College Graduate	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Education Post Graduate	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
State Trait Anger Inventory 2 (STAXI-2) Anger Expression Index Score	55.67 units on a scale STANDARD_DEVIATION 12.98 • n=5 Participants	54.77 units on a scale STANDARD_DEVIATION 11.86 • n=7 Participants	55.24 units on a scale STANDARD_DEVIATION 12.39 • n=5 Participants
Overt Anger Scale-Modified Aggression Scale	1.335 units on a scale STANDARD_DEVIATION 0.525 • n=5 Participants	1.396 units on a scale STANDARD_DEVIATION 0.500 • n=7 Participants	1.365 units on a scale STANDARD_DEVIATION 0.511 • n=5 Participants
Longitudinal Interval Follow up (LIFE) social functioning global score	3.57 units on a scale STANDARD_DEVIATION 0.54 • n=5 Participants	3.64 units on a scale STANDARD_DEVIATION 0.71 • n=7 Participants	3.61 units on a scale STANDARD_DEVIATION 0.63 • n=5 Participants
LIFE Work Functioning Global Score	3.17 units on a scale STANDARD_DEVIATION 1.22 • n=5 Participants	2.98 units on a scale STANDARD_DEVIATION 1.08 • n=7 Participants	3.08 units on a scale STANDARD_DEVIATION 1.15 • n=5 Participants
Outcomes Questionnaire	82.45 units on a scale STANDARD_DEVIATION 26.50 • n=5 Participants	88.31 units on a scale STANDARD_DEVIATION 22.93 • n=7 Participants	85.32 units on a scale STANDARD_DEVIATION 24.86 • n=5 Participants
WHO Quality of Life (WHOQOL) Psychological Domain	11.54 units on a scale STANDARD_DEVIATION 3.17 • n=5 Participants	10.97 units on a scale STANDARD_DEVIATION 2.61 • n=7 Participants	11.26 units on a scale STANDARD_DEVIATION 2.91 • n=5 Participants
Clinician Administered PTSD Scale (CAPS)	30.02 units on a scale STANDARD_DEVIATION 10.62 • n=5 Participants	32.38 units on a scale STANDARD_DEVIATION 9.52 • n=7 Participants	31.17 units on a scale STANDARD_DEVIATION 10.11 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment

Population: Participants were randomly assigned to CBI or SI. Those with one or more post-baseline assessments were included in Hierarchical Linear Model (HLM) analyses. Not all participants had post-baseline data; some treatment noncompleters had one or more post-baseline assessments. Least Square Means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=32 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=35 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Anger Expression Index Score on the State Trait Anger Inventory 2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline and Time Effects	41.42 score on a scale Standard Error 1.77	47.09 score on a scale Standard Error 1.65

PRIMARY outcome

Timeframe: Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment

Population: Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (4wk, 8wk, 12 wk, 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all participants had post-baseline data, and some non-completers had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated analyses of covariance are shown. Full Information Maximum Likelihood was used to account for missing data.

Structured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to no maximum, higher scores mean more anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=34 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=39 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Aggression Scale Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	1.00 units on a scale Standard Error 0.08	1.14 units on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

Population: Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.

Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation and satisfaction. The global social adjustment score is based upon a 5 point scale. Ratings are based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values range from 1 to 5, higher scores mean worse functioning.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=27 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=37 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Global Social Adjustment Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	2.85 units on a scale Standard Error 0.13	3.28 units on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation, satisfaction and global social adjustment. Ratings are based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values for the work functioning global score range from 1 to 5, higher scores mean worse functioning.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=27 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=37 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Global Work Functioning Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	2.78 units on a scale Standard Error 0.14	3.04 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 3 and 6 months post-treatment

The OQ is a self report measure that assesses functioning and includes three subscales: symptom distress, interpersonal relations, and social role functioning. Concurrent validity has been demonstrated in relation to internal consistency and reliability. Additionally, the OQ has been shown to be fairly stable in untreated individuals and sensitive to change in those individuals in treatment. Minimum and Maximum Values range from 0 to 180, higher scores mean worse functioning.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=26 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=37 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	60.69 score on a scale Standard Error 4.11	72.34 score on a scale Standard Error 3.27

SECONDARY outcome

Timeframe: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

The World Health Organization Quality of Life (WHOQOL-BREF), is 26 item self-report measure used to assess quality of life in multiple domains (i.e., physical, psychological, social, and environment). Psychometric properties suggest that the measure is valid and reliable across cultures and nations. Ratings are made on a 5 point scale. The psychological subscale, which consists of 6 items, was used in this study. Minimum and Maximum Values for the psychological domain range from 6 to 30, higher scores mean better quality of life.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=25 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=35 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	13.64 score on a scale Standard Error 0.40	12.09 score on a scale Standard Error 0.33

SECONDARY outcome

Timeframe: Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment

The CAPS-5 (updated for DSM-5) is a clinician administered structured interview for the assessment of DSM-5 PTSD. The CAPS has excellent reliability and validity and is widely used in PTSD treatment research. Each one of the DSM-5 PTSD symptoms is rated on a 0-4 (low to high) scale to determine symptom severity. The cutoff used to establish the presence of an individual symptom is a score of 2 or greater. Overall PTSD severity is computed by summing the totals for all items. Minimum and Maximum Values range from 0 to 80, higher scores mean higher levels of symptomatology.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=27 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=37 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean PTSD Severity Score on the Clinician-Administered PTSD Scale (CAPS) for DSM-5 Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	22.56 score on a scale Standard Error 2.01	24.71 score on a scale Standard Error 1.69

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12, 3 and 6 months Post-treatment

Population: Participants were randomly assigned to CBI or SI. Those with one or more post-baseline assessments (week 12, 3- and/or 6-month follow-up) were included in HLM analyses. Not all participants had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.

The ACQ is a brief self-report measure developed to assess the frequency of negative anger-related behavioral consequences. Internal consistencies of .75 to .91 have been reported. This scale includes items not covered by the other anger measures, including for example, trouble with the law, driving recklessly, getting into an accident, damaging relationships, etc. There are 50 items; minimum and maximum Values range from 0 to 200. Higher scores means more anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=25 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=35 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	30.48 score on a scale Standard Error 4.71	44.20 score on a scale Standard Error 3.75

POST_HOC outcome

Timeframe: The DAR was administered at each weekly 75-minute treatment session (up to 12 sessions). The mean DAR scores for sessions 1-4, 5-8, and 9-12 were calculated and used as outcome variables in the GLM repeated measures ANOVA.

Population: Participants were randomly assigned to CBI or SI. Participants with at one or more DARs completed during each of the time frames (sessions 1-4, 5-8, 9-12) were included in the analyses. Not all randomized participants had one or more DARs in all time frames. Some who did not complete treatment did have at least one DAR in all time frames.

The DAR is a 7 item self-report measure of anger reactions. It has been found to be reliable and sensitive to change. Higher scores reflect more severe anger. Scores can range from 0 to 28.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=25 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=34 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Mean Scores for Sessions 1-4, 5-8, and 9-12 on the Dimensions of Anger Response (DAR) Measure Using a Generalized Linear Model (GLM) Repeated Measures ANOVA Sessions 1-4	14.35 score on a scale Standard Deviation 4.91	15.43 score on a scale Standard Deviation 5.65
Mean Scores for Sessions 1-4, 5-8, and 9-12 on the Dimensions of Anger Response (DAR) Measure Using a Generalized Linear Model (GLM) Repeated Measures ANOVA Sessions 5-8	10.76 score on a scale Standard Deviation 5.77	12.96 score on a scale Standard Deviation 5.99
Mean Scores for Sessions 1-4, 5-8, and 9-12 on the Dimensions of Anger Response (DAR) Measure Using a Generalized Linear Model (GLM) Repeated Measures ANOVA Sessions 9-12	8.60 score on a scale Standard Deviation 5.80	11.88 score on a scale Standard Deviation 6.53

POST_HOC outcome

Timeframe: Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment

Population: Participants were randomly assigned to the CBI or SI. Those with at least one post-baseline measure (4wk, 8wk, 12 wk, 3 mo and/or 6 mo f/u) were included in HLM analysis. . Not all participants had post-baseline data, and some non-completers had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated analyses of covariance are shown. Full Information Maximum Likelihood was used to account for missing data.

The OAS-M is a structured Interview that assesses verbal and physical aggressive behaviors. The Global Anger and Aggression Score consists of two items - subjective experience and overt expression of anger, each rated on a scale from 0 to 5. Minimum and Maximum Values range from 0 to 10, higher scores means more anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=34 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=39 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Global Anger and Aggression Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	4.02 score on a scale Standard Error 0.29	4.84 score on a scale Standard Error 0.26

POST_HOC outcome

Timeframe: Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment

Population: Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (4wk, 8wk, 12 wk, 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.

The OAS-M is a structured Interview that assesses verbal and physical aggressive behaviors. Aggressive Outbursts is a measure of the frequency and severity of all aggressive outbursts over the past week.Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=34 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=39 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Aggressive Outbursts Score From the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	0.26 units on a scale Standard Error 0.03	0.34 units on a scale Standard Error 0.02

POST_HOC outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 month and 6 month follow-ups

The OAS-M is a structured interview that assesses frequency of anger and aggression. The verbal assault subscale measures the frequency and severity of verbal assaults over the previous week. Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=34 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=39 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Verbal Assault Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	0.85 units on a scale Standard Error 0.07	0.96 units on a scale Standard Error 0.06

POST_HOC outcome

Timeframe: Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment follow-ups

The OAS-M is a structured interview that assesses anger and aggressive behaviors. The Assaults on Objects Subscale assesses the frequency and severity of assaults against objects over the past week. Minimum and Maximum Values range from 0 to no maximum, higher scores means more assaults.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=34 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=39 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Assaults on Objects Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	0.19 units on a scale Standard Error 0.05	0.33 units on a scale Standard Error 0.04

POST_HOC outcome

Timeframe: Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment

The Assault Against Others Subscale assesses the frequency and severity of aggressive behaviors towards others. Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=34 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=39 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Assault Against Others Score on the Overt Aggression Scale-Modified Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	0.11 units on a scale Standard Error 0.06	0.14 units on a scale Standard Error 0.05

POST_HOC outcome

Timeframe: Baseline, weeks 4, 8, 12 (posttreatment), 3 and 6 months posttreatment

Population: All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were included in the analyses. Data were winsorized and log 10 transformed to counter high levels of skewness. Least Square means and differences adjusted for baseline and time effects from repeated analyses of covariance are shown. Full Information Maximum Likelihood was used to account for missing data.

The OAS-M is a structured interview assessing anger and aggression. The Assault against Self Subscale assesses the frequency and severity of aggression towards oneself during the past week. Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=34 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=39 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Assault Against Self Scale on the Overt Aggression Scale-Modified Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	0.11 units on a scale Standard Error 0.06	0.14 units on a scale Standard Error 0.05

POST_HOC outcome

Timeframe: Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment

Population: Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (4 wk, 8wk,12 wk (end of tx), 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.

The revised STAXI-2 is a 57 item self-report questionnaire that consists of five subscales and an anger expression index. The Anger Expression Out (AX-O) subscale measures how often angry feelings are expressed in verbally or physically aggressive behavior. It consists of 8 items, with a subscale range of 8 to 32. Higher scores indicate higher levels of expressed anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=33 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=36 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Anger Expression Out Scale Score on the State Trait Anger Inventory 2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	16.42 score on a scale Standard Error 0.44	18.27 score on a scale Standard Error 0.41

POST_HOC outcome

Timeframe: Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment

Population: Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (4 wk, 8 wk, 12 wk (posttreatment), 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline measures. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.

The revised STAXI-2 is a 57 item self-report questionnaire that consists of five subscales and an anger expression index. The Anger Expression In subscale measures how often angry feelings are experienced but not expressed (suppressed). It consists of 8 items with a score range of 8-32. Higher scores indicate higher levels of experienced anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=33 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=36 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Anger Expression Scale Score on the State-Trait Anger Inventory Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	18.31 score on a scale Standard Error 0.55	19.31 score on a scale Standard Error 0.52

POST_HOC outcome

Timeframe: Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment

Population: Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (posttreatment), 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline measures. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.

The STAXI-2 Anger Control Out subscale measures how often a person controls the outward expression of angry feelings. It consists of 8 items with a score range of 8 to 32. Higher scores reflect more effort in monitoring and preventing the outward expression of anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=32 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=36 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Score on the Anger Control Out Scale From the State Trait Anger Inventory-2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	20.07 score on a scale Standard Error 0.68	18.80 score on a scale Standard Error 0.62

POST_HOC outcome

Timeframe: Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment

The STAXI-2 Anger Control-In subscale measures how often a person attempts to control angry feelings by calming down or cooling off. It has 8 items with a score range of 8 to 32. Higher scores indicate more frequent attempts to control internal experiences of anger.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=33 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=36 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Anger Control-In Score on the State-Trait Anger Expression Inventory-2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	20.71 score on a scale Standard Error 0.68	19.38 score on a scale Standard Error 0.54

POST_HOC outcome

Timeframe: Baseline, week 12 (end of treatment), 3 and 6 months post-treatment

Population: Participants were randomly assigned to CBI or SI. Those with one or more post-baseline assessments (wk 12, 3- and/or 6-mo follow-up) were included in HLM analyses. Not all participants had post-baseline data, and some who didn't complete treatment had one or more post-baseline measures. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.

The Symptom Distress subscale assesses symptoms of affective disorders, anxiety disorders, adjustment disorders and stress related illness. It consists of 25 items, with a score range from 0 to 100. Higher scores indicate more symptoms and distress.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=26 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=37 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Symptom Distress Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	35.29 score on a scale Standard Error 2.56	41.58 score on a scale Standard Error 2.08

POST_HOC outcome

Timeframe: Baseline, Week 12 (End of Treatment), 3 and 6 months post-treatment

The OQ Interpersonal Relations subscale assesses complaints such as loneliness, conflicts with others, family and marriage problems. High scores reflect more difficulties in these areas. This subscale contains 11 items with a range of 0 to 44.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=26 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=37 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Least Squares Mean Interpersonal Relations Scale Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	14.66 score on a scale Standard Error 1.09	17.93 score on a scale Standard Error 0.86

POST_HOC outcome

Timeframe: Baseline, Week 12 (End of Treatment), 3 and 6 months post-treatment.

The Social Role scale measures the extent to which difficulties in the social roles of worker, homemaker, or student are present. This subscale contains 9 items with a range of 0 to 36. Higher scores indicate more conflicts at work, overwork, distress, and inefficiency in these roles.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Intervention (CBI) n=26 Participants 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management	Supportive Intervention (SI) n=37 Participants 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Mean Social Role Scale on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects	11.39 units on a scale Standard Error 0.82	12.68 units on a scale Standard Error 0.67

Adverse Events

Cognitive Behavioral Intervention

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Supportive Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive Behavioral Intervention n=47 participants at risk 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management.	Supportive Intervention n=45 participants at risk 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
Psychiatric disorders Panic Attack	4.3% 2/47 • Number of events 2 • 4 years	0.00% 0/45 • 4 years
Cardiac disorders Death	2.1% 1/47 • Number of events 1 • 4 years	0.00% 0/45 • 4 years
Psychiatric disorders Death	0.00% 0/47 • 4 years	2.2% 1/45 • Number of events 1 • 4 years

Other adverse events

Adverse event data not reported

Additional Information

M. Tracie Shea, PhD

Providence VA Medical Center

Phone: 401-273-7100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place