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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02157779
Acronym
TOTRA
Enrollment
112
Registered
2014-06-06
Start date
2015-01-01
Completion date
2019-02-28
Last updated
2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anger Problems

Keywords

Veterans, Anger, Cognitive Behavioral Therapy, Treatment

Brief summary

Excessive and poorly controlled anger is one of the most common problems experienced by war Veterans. The consequences can be severe, including increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Availability of effective treatments is critical to reducing the adverse effects of anger in Veterans. The investigators propose to conduct a controlled study to determine whether a cognitive behavior treatment that has been adapted for treating anger problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a supportive therapy. Results will be examined for improvement in anger, functioning, and quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.

Detailed description

Poorly controlled anger is a common problem with often devastating effects in Veterans who have served in a warzone. Adverse consequences include increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Recent evidence indicates that anger and aggression are likely to be problems for a significant proportion of Veterans of Iraq (Operation Iraqi Freedom, OIF; Operation New Dawn, OND) and Afghanistan (Operation Enduring Freedom, OEF). A survey of reintegration problems among 754 OEF/OIF combat Veterans receiving VA Medical care showed that anger was the most commonly reported problem, with 57% reporting increased problems in controlling anger. Despite encouraging evidence for efficacy of cognitive behavioral interventions in treating anger in civilian samples, much less is known about the efficacy of such treatments for anger problems in military personnel following exposure to war zone trauma. Promising preliminary findings for individually based cognitive behavioral treatment have been reported, and there is evidence that a group anger management treatment delivered by teleconferencing is as effective as the same treatment delivered in person, but to date there is not a single adequately powered randomized trial designed to test the efficacy of an anger treatment compared to an active control condition in Veterans. Building on findings from the investigators' randomized pilot study, the objective of the current proposal is to conduct a randomized clinical trial with sufficient statistical power to test the effectiveness of a manualized cognitive behavioral intervention (CBI) that has been adapted from an existing treatment (Anger Control Therapy; Novaco, 1994, 2001) for the treatment of anger problems in OEF/OIF/OND Veterans, compared to a manualized supportive therapy intervention (SI) control condition. Ninety OEF/OIF/OND Veterans reporting significant problems with anger will be randomized to receive 12 individual sessions of one of the two study conditions. Outcomes including measures of anger and aggression; interpersonal, social and occupational functioning; and quality of life will be assessed during and at the end of treatment and at 3 and 6 month follow-ups. Exploratory analyses will examine 1) whether a diagnosis of PTSD impacts treatment effectiveness and 2) potential mediators of treatment outcome with CBI.

Interventions

Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management

Includes individual therapy sessions using supportive and problem-solving strategies.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or Female current or former member of the military (active duty, National Guard or Reserve) Deployed to Iraq or Afghanistan * Experience trauma during deployment * Clinically significant anger * At least 2 additional symptoms of PTSD hyperarousal * If on medication, no changes within prior 4 weeks

Exclusion criteria

* Current severe substance use disorder or prior severe substance use disorder not in remission for at least 3 months * Current psychotic symptoms * current Mania or Bipolar Disorder * Current suicidal or homicidal ideation requiring hospitalization * Any severe cognitive impairment or history of Organic Mental Disorder

Design outcomes

Primary

MeasureTime frameDescription
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 EffectsBaseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatmentStructured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to no maximum, higher scores mean more anger.
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 EffectsBaseline, Weeks 4, 8,12, 3 and 6 months post-treatmentThe 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.

Secondary

MeasureTime frameDescription
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 EffectsBaseline, 12 weeks (end of treatment), 3 and 6 months post-treatmentPsychosocial 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.
Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time EffectsBaseline, 12 weeks, 3 and 6 months post-treatmentThe 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.
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 EffectsBaseline,12 weeks (end of treatment), 3 and 6 months post-treatmentThe 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.
Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time EffectsBaseline, 12 weeks (end of treatment), 3 and 6 months post-treatmentThe 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.
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 EffectsBaseline, 12 weeks (end of treatment), 3 and 6 months post-treatmentPsychosocial 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.

Other

MeasureTime frameDescription
Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time EffectsBaseline, Week 12, 3 and 6 months Post-treatmentThe 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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
47
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.
45
Total92

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLegal issue10
Overall StudyLogistical93
Overall StudyMedical10
Overall StudyMoved10
Overall StudyNo response to outreach after Baseline11
Overall StudyStopped attending, reason unknown117

Baseline characteristics

CharacteristicSupportive InterventionCognitive Behavioral InterventionTotal
Age, Continuous36.5 years
STANDARD_DEVIATION 9.77
35.30 years
STANDARD_DEVIATION 9.11
35.90 years
STANDARD_DEVIATION 9.41
Clinician Administered PTSD Scale (CAPS)32.38 units on a scale
STANDARD_DEVIATION 9.52
30.02 units on a scale
STANDARD_DEVIATION 10.62
31.17 units on a scale
STANDARD_DEVIATION 10.11
Education
College Graduate
7 Participants4 Participants11 Participants
Education
High School Graduate/GED
11 Participants11 Participants22 Participants
Education
Post Graduate
3 Participants2 Participants5 Participants
Education
Some College/Technical School
24 Participants30 Participants54 Participants
Employment Status
Full Time
27 Participants22 Participants49 Participants
Employment Status
Part Time
15 Participants5 Participants20 Participants
Employment Status
Retired
0 Participants6 Participants6 Participants
Employment Status
Unemployed
3 Participants14 Participants17 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants7 Participants19 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants40 Participants73 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
LIFE Work Functioning Global Score2.98 units on a scale
STANDARD_DEVIATION 1.08
3.17 units on a scale
STANDARD_DEVIATION 1.22
3.08 units on a scale
STANDARD_DEVIATION 1.15
Longitudinal Interval Follow up (LIFE) social functioning global score3.64 units on a scale
STANDARD_DEVIATION 0.71
3.57 units on a scale
STANDARD_DEVIATION 0.54
3.61 units on a scale
STANDARD_DEVIATION 0.63
Outcomes Questionnaire88.31 units on a scale
STANDARD_DEVIATION 22.93
82.45 units on a scale
STANDARD_DEVIATION 26.5
85.32 units on a scale
STANDARD_DEVIATION 24.86
Overt Anger Scale-Modified Aggression Scale1.396 units on a scale
STANDARD_DEVIATION 0.5
1.335 units on a scale
STANDARD_DEVIATION 0.525
1.365 units on a scale
STANDARD_DEVIATION 0.511
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants1 Participants4 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
4 Participants1 Participants5 Participants
Race (NIH/OMB)
More than one race
3 Participants2 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
35 Participants42 Participants77 Participants
Sex: Female, Male
Female
2 Participants1 Participants3 Participants
Sex: Female, Male
Male
43 Participants46 Participants89 Participants
State Trait Anger Inventory 2 (STAXI-2) Anger Expression Index Score54.77 units on a scale
STANDARD_DEVIATION 11.86
55.67 units on a scale
STANDARD_DEVIATION 12.98
55.24 units on a scale
STANDARD_DEVIATION 12.39
WHO Quality of Life (WHOQOL) Psychological Domain10.97 units on a scale
STANDARD_DEVIATION 2.61
11.54 units on a scale
STANDARD_DEVIATION 3.17
11.26 units on a scale
STANDARD_DEVIATION 2.91

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 471 / 45
other
Total, other adverse events
0 / 470 / 45
serious
Total, serious adverse events
3 / 471 / 45

Outcome results

Primary

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

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

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects1.00 units on a scaleStandard Error 0.08
Supportive Intervention (SI)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 Effects1.14 units on a scaleStandard Error 0.07
Comparison: Population Description: 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 used in the statistical analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.p-value: 0.1995% CI: [-0.33, 0.06]ANCOVA
Primary

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects41.42 score on a scaleStandard Error 1.77
Supportive Intervention (SI)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 Effects47.09 score on a scaleStandard Error 1.65
Comparison: 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 used in the HLM analyses.p-value: 0.01795% CI: [-10.32, -1.01]ANCOVA
Secondary

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects2.85 units on a scaleStandard Error 0.13
Supportive Intervention (SI)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 Effects3.28 units on a scaleStandard Error 0.1
Comparison: Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.p-value: 0.01195% CI: [-0.75, -0.09]ANCOVA
Secondary

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects2.78 units on a scaleStandard Error 0.14
Supportive Intervention (SI)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 Effects3.04 units on a scaleStandard Error 0.12
Comparison: All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment, 3 month and/or 6 month follow-up) were included in the analyses.p-value: 0.1695% CI: [-0.63, 0.11]ANCOVA
Secondary

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects13.64 score on a scaleStandard Error 0.4
Supportive Intervention (SI)Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects12.09 score on a scaleStandard Error 0.33
Comparison: All randomized participants with at least one post-baseline assessment (week 12 (end of treatment), 3 month, and/or 6 month follow-up) were used in the statistical analysis.p-value: 0.00495% CI: [0.51, 2.6]ANCOVA
Secondary

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects22.56 score on a scaleStandard Error 2.01
Supportive Intervention (SI)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 Effects24.71 score on a scaleStandard Error 1.69
Comparison: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.p-value: 0.41695% CI: [-7.37, 3.07]ANCOVA
Secondary

Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

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.

Time frame: Baseline, 12 weeks, 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects60.69 score on a scaleStandard Error 4.11
Supportive Intervention (SI)Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects72.34 score on a scaleStandard Error 3.27
Comparison: All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment), 3 month and/or 6 month follow-up) were included in the statistical analyses.p-value: 0.03195% CI: [-22.2, -1.09]ANCOVA
Post Hoc

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects0.26 units on a scaleStandard Error 0.03
Supportive Intervention (SI)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 Effects0.34 units on a scaleStandard Error 0.02
Comparison: All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.p-value: 0.02195% CI: [-0.158, -0.011]ANCOVA
Post Hoc

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

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.

Time frame: 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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects20.71 score on a scaleStandard Error 0.68
Supportive Intervention (SI)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 Effects19.38 score on a scaleStandard Error 0.54
Comparison: All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data.p-value: 0.195% CI: [-0.26, 2.92]ANCOVA
Post Hoc

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects16.42 score on a scaleStandard Error 0.44
Supportive Intervention (SI)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 Effects18.27 score on a scaleStandard Error 0.41
Comparison: All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.p-value: 0.00295% CI: [-3.038, -0.663]ANCOVA
Post Hoc

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Least Squares Mean Anger Expression Scale Score on the State-Trait Anger Inventory Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects18.31 score on a scaleStandard Error 0.55
Supportive Intervention (SI)Least Squares Mean Anger Expression Scale Score on the State-Trait Anger Inventory Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects19.31 score on a scaleStandard Error 0.52
Comparison: All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.p-value: 0.18695% CI: [-2.518, 0.524]ANCOVA
Post Hoc

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

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.

Time frame: 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 (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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Least Squares Mean Assault Against Others Score on the Overt Aggression Scale-Modified Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects0.11 units on a scaleStandard Error 0.06
Supportive Intervention (SI)Least Squares Mean Assault Against Others Score on the Overt Aggression Scale-Modified Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects0.14 units on a scaleStandard Error 0.05
Comparison: All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.p-value: 0.78695% CI: [-0.213, 0.1614]ANCOVA
Post Hoc

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Least Squares Mean Assault Against Self Scale on the Overt Aggression Scale-Modified Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects0.11 units on a scaleStandard Error 0.06
Supportive Intervention (SI)Least Squares Mean Assault Against Self Scale on the Overt Aggression Scale-Modified Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects0.14 units on a scaleStandard Error 0.05
Comparison: All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.p-value: 0.74495% CI: [-0.18, 0.13]ANCOVA
Post Hoc

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

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.

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

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects0.19 units on a scaleStandard Error 0.05
Supportive Intervention (SI)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 Effects0.33 units on a scaleStandard Error 0.04
Comparison: All randomized participants with at least one post-baseline assessment were used in the statistical analysis. Data were winsorized and log 10 transformed to counter high levels of skewness.p-value: 0.03695% CI: [-0.27, -0.01]ANCOVA
Post Hoc

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects4.02 score on a scaleStandard Error 0.29
Supportive Intervention (SI)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 Effects4.84 score on a scaleStandard Error 0.26
Comparison: All randomized participants with at least one post-baseline assessment (week 4, week 8, week 12 (end of treatment), 3 mo and/or 6 month follow-up) were included in the HLM analyses.p-value: 0.0395% CI: [-1.578, -0.063]ANCOVA
Post Hoc

Least Squares Mean Interpersonal Relations Scale Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

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.

Time frame: 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 (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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Least Squares Mean Interpersonal Relations Scale Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects14.66 score on a scaleStandard Error 1.09
Supportive Intervention (SI)Least Squares Mean Interpersonal Relations Scale Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects17.93 score on a scaleStandard Error 0.86
Comparison: All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data.p-value: 0.02395% CI: [-6.083, -0.458]ANCOVA
Post Hoc

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

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects20.07 score on a scaleStandard Error 0.68
Supportive Intervention (SI)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 Effects18.80 score on a scaleStandard Error 0.62
Comparison: All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data.p-value: 0.16495% CI: [-0.56, 3.09]ANCOVA
Post Hoc

Least Squares Mean Symptom Distress Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Least Squares Mean Symptom Distress Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects35.29 score on a scaleStandard Error 2.56
Supportive Intervention (SI)Least Squares Mean Symptom Distress Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects41.58 score on a scaleStandard Error 2.08
Comparison: All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data.p-value: 0.0695% CI: [-12.85, 0.27]ANCOVA
Other Pre-specified

Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects30.48 score on a scaleStandard Error 4.71
Supportive Intervention (SI)Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects44.20 score on a scaleStandard Error 3.75
Comparison: All randomized participants with at least one post-baseline assessment were used in the analyses.p-value: 0.02895% CI: [-25.94, -1.5]ANCOVA
Post Hoc

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

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.

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

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 Effects0.85 units on a scaleStandard Error 0.07
Supportive Intervention (SI)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 Effects0.96 units on a scaleStandard Error 0.06
Comparison: All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were used in the HLM analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.p-value: 0.24695% CI: [-0.283, 0.073]ANCOVA
Post Hoc

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

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)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 ANOVASessions 1-414.35 score on a scaleStandard Deviation 4.91
Cognitive Behavioral Intervention (CBI)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 ANOVASessions 5-810.76 score on a scaleStandard Deviation 5.77
Cognitive Behavioral Intervention (CBI)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 ANOVASessions 9-128.60 score on a scaleStandard Deviation 5.8
Supportive Intervention (SI)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 ANOVASessions 1-415.43 score on a scaleStandard Deviation 5.65
Supportive Intervention (SI)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 ANOVASessions 5-812.96 score on a scaleStandard Deviation 5.99
Supportive Intervention (SI)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 ANOVASessions 9-1211.88 score on a scaleStandard Deviation 6.53
Comparison: All randomized participants with at least one DAR completed in each time frame (sessions 1-4, 5-8, and 9-12) were included in the analyses. 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.p-value: 0.13ANOVA
Post Hoc

Mean Social Role Scale on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

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.

Time frame: 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 (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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cognitive Behavioral Intervention (CBI)Mean Social Role Scale on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects11.39 units on a scaleStandard Error 0.82
Supportive Intervention (SI)Mean Social Role Scale on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects12.68 units on a scaleStandard Error 0.67
Comparison: All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data.p-value: 0.2395% CI: [-3.39, 0.82]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026