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Group CBT for Aggression in Veterans

Group Cognitive Behavioral Therapy for Anger and Aggression in Veterans With PTSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02233517
Acronym
CBT-A
Enrollment
66
Registered
2014-09-08
Start date
2015-02-09
Completion date
2017-07-05
Last updated
2019-05-31

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

Conditions

Aggression, Anger, Posttraumatic Stress Disorder

Keywords

Veterans, Cognitive-Behavioral Therapy, Aggression, Anger, Posttraumatic Stress Disorder, Combat Disorders

Brief summary

Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S. Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among their top priorities. PTSD-related anger and aggression are associated with profound functional impairments, yet to date there are no empirically-supported treatments for Veterans with PTSD and aggression. Effective group treatment programs could improve functioning and facilitate community reintegration for these Veterans. Given that anger impedes progress in treatment of PTSD symptoms, group anger treatment could also improve Veterans' capacity to benefit from individually-administered empirically-supported therapy for PTSD such as prolonged exposure or cognitive processing therapy.

Detailed description

Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression (Olatunji, Ciesielski, & Tolin, 2010), and U.S. Iraq/Afghanistan-era Veterans report that controlling anger and aggressive urges are primary readjustment concerns (Sayer et al, 2010). Trauma-related anger and aggression are associated with functional impairments that significantly limit community reintegration (Rodriguez, Holowka, & Marx, 2012) and that may persist for decades (Koenen et al, 2003). As more troops return from multiple deployments to Iraq and Afghanistan, there is an urgent and growing need for the development and testing of psychosocial treatment for anger and aggression in combat Veterans with PTSD. VA clinicians are doing their best to be responsive to Veteran's needs by offering anger management treatment to Veterans: A survey of clinical practices within the VA found that 35-65% of VA PTSD specialists report providing anger management to their patients (Rosen et al., 2004). Yet to date only one randomized clinical trial (RCT), published in 1997, has investigated the efficacy of treatment of anger and aggression in Veterans with PTSD (Chemtob et al., 1997). A recent review noted that most researchers who have examined the effects of anger management interventions have not done so as part of a systematic program of research (DiGiuseppe and Tafrate, 2003). The proposed CDA-2 application outlines Training and Mentoring Plans that will provide the applicant with the foundation to establish a career systematically developing, testing, and refining treatments for PTSD-related anger and aggression in Veterans. The following specific Training Goals have been formulated: 1) To acquire the advanced skills in the development and evaluation of clinical interventions necessary to begin an independent research career within the VA; 2) To develop greater expertise in delivery of behavioral interventions to improve functional outcomes and community reintegration in Veterans with PTSD, anger problems, and aggression; 3) To acquire expertise in the development and evaluation of treatment innovations to help Veterans generalize treatment gains beyond the therapy setting; 4) To increase understanding of rehabilitation theory and methods in treatment practices and research; and 5) To achieve critical professional development milestones, including submission of a Merit Review proposal based on the pilot data generated from the CDA-2 project. The Research Plan proposes a pilot feasibility trial for an RCT of Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A). CBT-A is a 12-week manualized group treatment protocol that has been designed to address the specific needs of combat Veterans whose PTSD-related anger and aggression interfere with effective community reintegration. The group was implemented with 4 male Vietnam Veterans with severe combat-related PTSD who were referred for anger management treatment, and preliminary data were promising. The active comparison treatment for the pilot RCT will be group Present-Centered Therapy (PCT), a manualized treatment for PTSD that controls for treatment time, social support, and instillation of hope. The proposed research project will address the following Specific Aims: Aim 1: Characterize the differential effects of group CBT-A and group PCT on anger, aggression, and anger/aggression-related limitations to psychosocial functioning and community reintegration in combat Veterans with PTSD; and Aim 2: Evaluate study feasibility and treatment delivery procedures of an RCT comparing CBT-A to a PCT comparison condition. The results generated will guide the design of a full RCT to be funded by the end of the CDA-2 funding period. The research, training, and mentoring plans outlined here will provide the foundation for the PI's independent research career developing a systematic program of research in the treatment of anger and aggression among combat Veterans with PTSD. The availability of empirically-supported anger treatment would benefit the many Veterans with PTSD who return from combat reporting problems with anger and aggression.

Interventions

BEHAVIORALCognitive Behavioral Therapy

Cognitive Behavioral Therapy provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning.

Present Centered Therapy utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the here-and-now to support patients in their efforts to improve functioning.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

A Veteran will meet criteria for inclusion if he/she meets all of the following criteria: * Current PTSD based on the CAPS; * served in combat (regardless of era or country of combat service); * can speak and write fluent conversational English; * at least 18 years of age; * report problems with irritability, anger, or aggression within the past month. Problems with anger and aggression will be defined via the rule of 4: Inclusion in the study will require a CAPS-V score \> 2 on item 15 (E1), irritable or angry and showed it in your behavior item within the past month.

Exclusion criteria

A Veteran will be excluded from participation if he/she: * is expected to be unstable on his/her medication regimen during the study; * currently meets criteria for Bipolar I Disorder or a primary psychotic disorder as determined by the Structured Clinical Interview for the DSM (most current version available) (SCID); * is receiving (or plan to) other anger-management psychotherapy during the course of the study; * will be undergoing empirically supported psychotherapy for PTSD during the treatment component of the study; * meets criteria for substance dependence (other than nicotine) within the past month as determined by the SCID; or * is determined to have moderate or severe impairment related to traumatic brain injury as measured by the Brief Traumatic Brain Injury Screen and consultation with the Veteran's provider.

Design outcomes

Primary

MeasureTime frameDescription
Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)Physically aggressive behaviors including throwing something at someone, pushing, grabbing, shoving, slapping, kicking, biting, hitting, beating up, threatening with a gun or knife, or using a gun or knife on someone. Scale range 0 (never) to 6 (more than 20 times) over past 30 days.
Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)The NAS is a measure anger and coping that indexes four aspects of the experience of anger: Cognitive, Arousal, Behavior, and Anger Regulation. The T-score for the total NAS is used as the outcome, with a range of 0 to 100. Higher scores reflect greater impairment.
Change in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-uppre-treatment (baseline), weekly treatment sessions, post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. The scale will be administered weekly to provide information about the pattern of change in anger- and aggression-related cognitions over the course of the group. Scores range from 0 to 56, with higher scores reflecting greater impairment.

Secondary

MeasureTime frameDescription
Change in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)The 12-item, self-report version of the WHO-DAS 2.0 will be administered to assess the impact of anger and aggression on broad functioning, as well as across six ICF functioning domains of mobility, self-care, getting along, life activities (household and work) and participation. In addition to the outcome time frame listed above, the WHO-DAS 2.0 will be administered weekly to collect exploratory information about Veterans' perceptions of how their overall functioning changes over the course of the group. The scale range is 0 to 48, with higher scores reflecting greater impairment.
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.pre-treatment (baseline), post-treatment (12 weeks)The computer-adaptive version of the CRIS was developed specifically to assess the ICF domain of Participation in Veterans. The Perceived Limitations to Participation subscale assesses Veterans' perceived limitations in participation, and includes items such as I felt that I easily lost control of my feelings. The Extent of Participation subscale assesses how often Veterans experience a challenge in participation, and includes items such as How often did you get together with friends? The Satisfaction with Participation subscale assesses Veterans' level of satisfaction with participation, and includes items such as How satisfied were you with your daily accomplishments? Each of the scales has a range of 0-100, with higher scores reflecting better functioning.
Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)The IPF is an 80-item self-report measure that assesses functioning over the past 30 days in the following domains: romantic relationships; family relationships; work; friendships and socializing; parenting; academic pursuits; and self-care. The IPF Total score will be used in these analyses. Scores range from 11 to 80, with higher scores reflecting greater functional impairment.
The McMaster Family Assessment Device (FAD)pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatmentThe FAD is a 60-item scale that consists of statements about families to which respondents indicated agreement or disagreement on a 4-point scale. It yields a General Functioning (GF) score, as well as indices of 6 areas of family activity: problem solving; communication; roles; affective responses; affective involvement; and behavioral control. The General Functioning Scale will be used for this outcome. The General Functional Scale scores range from 1-4, with higher scores reflect greater impairment.

Other

MeasureTime frameDescription
PTSD Checklist (PCL)pre-treatment (baseline), post-treatment (12 weeks)On the PCL participants first report an autobiographical narrative of a trauma, and subsequently rate symptom frequency (0 \[not at all\] - 4 \[everyday\]) and severity (0 \[not at all distressing\] - 4 \[extremely distressing\]) for all DSM-V PTSD symptoms within the past week. The PCL will be administered weekly to evaluate the association of PTSD symptoms with anger cognitions (as measured by the DAR) over the course of the group. Total score ranges from 0 to 80, with higher scores reflecting greater impairment.
The Drug Abuse Screening Test (DAST)pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks)The DAST contains 20 yes/no questions about behavior and symptoms pertaining to substance use. Scale range is 0-20, with higher scores reflecting greater impairment.
The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)The Adaptability Scale is an 8-item subscale of the CD-RISC that measures adaptability in the face of challenges (e.g., I am able to adapt when changes occur). Cronbach's alpha for the 8-item Adaptability scale was found to be .91 in a sample of 1981Veterans (Green et al, under review). One of the primary goals of the CBT-A intervention is to increase Veterans' behavioral repertoire and range of Activities by targeting maladaptive Thought Functions and Emotion Functions. The Adaptability scale of the CD-RISC will be included among the outcome measures as it may assess improvements in Thought Functions and Emotion Functions that underlie limitations to Activities and Participation. The Adaptability scale scores can range from 0 to 32, with higher scores reflecting better functioning.
The Alcohol Use Disorder Identification Test (AUDIT)pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)The AUDIT contains 10 multiple choice questions about behavior and symptoms related to alcohol consumption. Scale scores range from 0 to 40, with higher scores reflecting greater impairment. Scores over 8 reflect a strong likelihood of hazardous our harmful alcohol consumption.

Countries

United States

Participant flow

Pre-assignment details

30 participants were excluded after enrollment: 13 did not meet inclusion criteria; 17 declined to participate or were lost to contact.

Participants by arm

ArmCount
Cognitive Behavioral Therapy
Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol. Each session lasts 90 minutes. The first session orients participants to the structure and philosophy of the program, provides a historical overview of PTSD, and introduces the concept of the survival mode of functioning. The remaining 11 sessions follow a standard format: 1) practice relaxation training (15-20 minutes); 2) review homework, introduce new material, and engage in group activities focused on implementing new skills and behaviors (70-80 minutes); and 3) review problems or concerns of group members. CBT-A provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning.
19
Present Centered Therapy
Present Centered Therapy (PCT) is an active, manualized treatment comparison condition for psychotherapy trials. PCT is designed to control for nonspecific factors of therapy such as contact with a trained therapist, rationale for treatment, and instillation of expectancy for therapeutic gains. The therapeutic approach was drawn from Yalom's group therapy model, which utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the here-and-now. Previous large-scale randomized clinical trials of Veterans with PTSD have found reduced PTSD symptoms in the PCT comparison condition (Schnurr et al., 2003), and a survey of practice patterns within the VA suggests that similar present-focused approaches are routinely employed by VA mental health providers (Rosen et al., 2004). Consistent with recommendations in the PCT manual, training will emphasize the approach rather than specific interventions.
17
Total36

Baseline characteristics

CharacteristicCognitive Behavioral TherapyPresent Centered TherapyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants4 Participants7 Participants
Age, Categorical
Between 18 and 65 years
16 Participants13 Participants29 Participants
Age, Continuous50.8 years
STANDARD_DEVIATION 11.7
52.6 years
STANDARD_DEVIATION 12.3
51.6 years
STANDARD_DEVIATION 11.9
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants16 Participants35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
11 Participants10 Participants21 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 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
7 Participants7 Participants14 Participants
Region of Enrollment
United States
19 Participants17 Participants36 Participants
Sex: Female, Male
Female
5 Participants6 Participants11 Participants
Sex: Female, Male
Male
14 Participants11 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 17
other
Total, other adverse events
0 / 190 / 17
serious
Total, serious adverse events
2 / 191 / 17

Outcome results

Primary

Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.

Physically aggressive behaviors including throwing something at someone, pushing, grabbing, shoving, slapping, kicking, biting, hitting, beating up, threatening with a gun or knife, or using a gun or knife on someone. Scale range 0 (never) to 6 (more than 20 times) over past 30 days.

Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Population: Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed. One participant (male, PCT arm) contacted, confirmed that 3 month data was invalid; data for this subject, this time point, this measure not used.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyChange in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.3-month follow-up0.61 units on a scaleStandard Deviation 1.5
Cognitive Behavioral TherapyChange in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.Baseline0.50 units on a scaleStandard Deviation 0.99
Cognitive Behavioral TherapyChange in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.6-month follow-up0.94 units on a scaleStandard Deviation 2.04
Cognitive Behavioral TherapyChange in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.post-treatment0.22 units on a scaleStandard Deviation 0.73
Present Centered TherapyChange in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.6-month follow-up1.18 units on a scaleStandard Deviation 4.11
Present Centered TherapyChange in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.Baseline1.24 units on a scaleStandard Deviation 4.13
Present Centered TherapyChange in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.3-month follow-up1.19 units on a scaleStandard Deviation 4.23
Present Centered TherapyChange in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.post-treatment1.06 units on a scaleStandard Deviation 4.12
p-value: 0.84Mixed Models Analysis
p-value: <0.44Mixed Models Analysis
p-value: 0.33Mixed Models Analysis
Primary

Change in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up

The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. The scale will be administered weekly to provide information about the pattern of change in anger- and aggression-related cognitions over the course of the group. Scores range from 0 to 56, with higher scores reflecting greater impairment.

Time frame: pre-treatment (baseline), weekly treatment sessions, post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Population: Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed. Data for baseline session incomplete/unscorable for one participant (female, CBT arm); her data not included in outcome means table, so n for CBT arm is 17.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyChange in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-upbaseline40.2 units on a scaleStandard Deviation 12.6
Cognitive Behavioral TherapyChange in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-uppost-treatment34.6 units on a scaleStandard Deviation 14.2
Cognitive Behavioral TherapyChange in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up3 month follow-up35.8 units on a scaleStandard Deviation 13.2
Cognitive Behavioral TherapyChange in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up6 month follow-up35.5 units on a scaleStandard Deviation 13.4
Present Centered TherapyChange in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up6 month follow-up36.1 units on a scaleStandard Deviation 12.7
Present Centered TherapyChange in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-upbaseline41.2 units on a scaleStandard Deviation 10.4
Present Centered TherapyChange in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up3 month follow-up38.2 units on a scaleStandard Deviation 13.9
Present Centered TherapyChange in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-uppost-treatment36.8 units on a scaleStandard Deviation 14.6
Comparison: Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on DAR scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.p-value: 0.26Mixed Models Analysis
Primary

Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.

The NAS is a measure anger and coping that indexes four aspects of the experience of anger: Cognitive, Arousal, Behavior, and Anger Regulation. The T-score for the total NAS is used as the outcome, with a range of 0 to 100. Higher scores reflect greater impairment.

Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Population: The NAS was not used with the first cohort of CBT, so the total N for this measure is 28. Last observation carried forward used to address missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyChange in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.baseline74.2 units on a scaleStandard Deviation 4.6
Cognitive Behavioral TherapyChange in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.post-treatment74.3 units on a scaleStandard Deviation 5
Cognitive Behavioral TherapyChange in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.3 month follow-up74.8 units on a scaleStandard Deviation 3.3
Cognitive Behavioral TherapyChange in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.6 month follow-up74.7 units on a scaleStandard Deviation 2.6
Present Centered TherapyChange in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.6 month follow-up76.1 units on a scaleStandard Deviation 3.4
Present Centered TherapyChange in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.baseline75.9 units on a scaleStandard Deviation 3.1
Present Centered TherapyChange in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.3 month follow-up76.3 units on a scaleStandard Deviation 3
Present Centered TherapyChange in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.post-treatment76.1 units on a scaleStandard Deviation 3.5
p-value: 0.85Mixed Models Analysis
p-value: 0.79Mixed Models Analysis
p-value: 0.9Mixed Models Analysis
Secondary

Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.

The computer-adaptive version of the CRIS was developed specifically to assess the ICF domain of Participation in Veterans. The Perceived Limitations to Participation subscale assesses Veterans' perceived limitations in participation, and includes items such as I felt that I easily lost control of my feelings. The Extent of Participation subscale assesses how often Veterans experience a challenge in participation, and includes items such as How often did you get together with friends? The Satisfaction with Participation subscale assesses Veterans' level of satisfaction with participation, and includes items such as How satisfied were you with your daily accomplishments? Each of the scales has a range of 0-100, with higher scores reflecting better functioning.

Time frame: pre-treatment (baseline), post-treatment (12 weeks)

Population: Last observation carried forward analyses used. Three participants did not have baseline measures, so were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Baseline, Perceived Limitations41.1 units on a scaleStandard Deviation 3.5
Cognitive Behavioral TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Post-treatment, Perceived Limitations40.7 units on a scaleStandard Deviation 3.2
Cognitive Behavioral TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Baseline, Extent of Participation38.4 units on a scaleStandard Deviation 6.3
Cognitive Behavioral TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Post-treatment, Extent of Participation37.7 units on a scaleStandard Deviation 5.8
Cognitive Behavioral TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Baseline, Satisfacation41.4 units on a scaleStandard Deviation 3.6
Cognitive Behavioral TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Post-treatment, Satisfaction41.6 units on a scaleStandard Deviation 3.7
Present Centered TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Baseline, Satisfacation40.7 units on a scaleStandard Deviation 3.4
Present Centered TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Baseline, Perceived Limitations41.0 units on a scaleStandard Deviation 4.6
Present Centered TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Post-treatment, Extent of Participation39.5 units on a scaleStandard Deviation 8.5
Present Centered TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Post-treatment, Perceived Limitations41.1 units on a scaleStandard Deviation 5.9
Present Centered TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Post-treatment, Satisfaction41.6 units on a scaleStandard Deviation 4.4
Present Centered TherapyChange in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.Baseline, Extent of Participation37.9 units on a scaleStandard Deviation 7.9
Comparison: This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Extent of Participation scale.p-value: 0.0595% CI: [-4.5, -0.002]t-test, 2 sided
Comparison: This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Perceived Limitations scale.p-value: 0.5395% CI: [-2.03, 1.08]t-test, 2 sided
Comparison: This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Satisfaction scale.p-value: 0.595% CI: [-2.3, 1.14]t-test, 2 sided
Secondary

Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.

The IPF is an 80-item self-report measure that assesses functioning over the past 30 days in the following domains: romantic relationships; family relationships; work; friendships and socializing; parenting; academic pursuits; and self-care. The IPF Total score will be used in these analyses. Scores range from 11 to 80, with higher scores reflecting greater functional impairment.

Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Population: Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyChange in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.Baseline47.7 units on a scaleStandard Deviation 10.7
Cognitive Behavioral TherapyChange in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.Post-treatment48.5 units on a scaleStandard Deviation 12.7
Cognitive Behavioral TherapyChange in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.3 month follow-up50.5 units on a scaleStandard Deviation 13.2
Cognitive Behavioral TherapyChange in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.6 month follow-up49.2 units on a scaleStandard Deviation 10.7
Present Centered TherapyChange in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.6 month follow-up55.8 units on a scaleStandard Deviation 14.7
Present Centered TherapyChange in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.Baseline53.4 units on a scaleStandard Deviation 15.4
Present Centered TherapyChange in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.3 month follow-up54.8 units on a scaleStandard Deviation 14.1
Present Centered TherapyChange in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.Post-treatment52.7 units on a scaleStandard Deviation 14.9
p-value: 0.59Mixed Models Analysis
p-value: 0.61Mixed Models Analysis
p-value: 0.74Mixed Models Analysis
Secondary

Change in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.

The 12-item, self-report version of the WHO-DAS 2.0 will be administered to assess the impact of anger and aggression on broad functioning, as well as across six ICF functioning domains of mobility, self-care, getting along, life activities (household and work) and participation. In addition to the outcome time frame listed above, the WHO-DAS 2.0 will be administered weekly to collect exploratory information about Veterans' perceptions of how their overall functioning changes over the course of the group. The scale range is 0 to 48, with higher scores reflecting greater impairment.

Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Population: For participants without baseline data, the data from the first (of 12) intervention sessions was used as baseline. Last observation carried forward was used for all analyses. Data screening found one participant's data (male, CBT arm) were not valid; his data was not used.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyChange in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.Baseline19.3 units on a scaleStandard Deviation 8.3
Cognitive Behavioral TherapyChange in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.Post-treatment21.6 units on a scaleStandard Deviation 9
Cognitive Behavioral TherapyChange in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.3 month follow-up20.1 units on a scaleStandard Deviation 9.4
Cognitive Behavioral TherapyChange in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.6 month follow-up22.0 units on a scaleStandard Deviation 8.7
Present Centered TherapyChange in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.6 month follow-up22.3 units on a scaleStandard Deviation 7.7
Present Centered TherapyChange in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.Baseline24.6 units on a scaleStandard Deviation 7.3
Present Centered TherapyChange in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.3 month follow-up22.4 units on a scaleStandard Deviation 8.2
Present Centered TherapyChange in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.Post-treatment20.7 units on a scaleStandard Deviation 9.7
Comparison: Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).p-value: <0.0001Mixed Models Analysis
Secondary

The McMaster Family Assessment Device (FAD)

The FAD is a 60-item scale that consists of statements about families to which respondents indicated agreement or disagreement on a 4-point scale. It yields a General Functioning (GF) score, as well as indices of 6 areas of family activity: problem solving; communication; roles; affective responses; affective involvement; and behavioral control. The General Functioning Scale will be used for this outcome. The General Functional Scale scores range from 1-4, with higher scores reflect greater impairment.

Time frame: pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatment

Population: Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyThe McMaster Family Assessment Device (FAD)Baseline2.81 units on a scaleStandard Deviation 0.61
Cognitive Behavioral TherapyThe McMaster Family Assessment Device (FAD)3 month follow-up2.89 units on a scaleStandard Deviation 0.52
Cognitive Behavioral TherapyThe McMaster Family Assessment Device (FAD)6 month follow-up2.86 units on a scaleStandard Deviation 0.48
Cognitive Behavioral TherapyThe McMaster Family Assessment Device (FAD)Post-treatment2.72 units on a scaleStandard Deviation 0.49
Present Centered TherapyThe McMaster Family Assessment Device (FAD)6 month follow-up2.49 units on a scaleStandard Deviation 0.65
Present Centered TherapyThe McMaster Family Assessment Device (FAD)Baseline2.50 units on a scaleStandard Deviation 0.44
Present Centered TherapyThe McMaster Family Assessment Device (FAD)Post-treatment2.60 units on a scaleStandard Deviation 0.51
Present Centered TherapyThe McMaster Family Assessment Device (FAD)3 month follow-up2.58 units on a scaleStandard Deviation 0.51
p-value: 0.25Mixed Models Analysis
p-value: 0.97Mixed Models Analysis
p-value: 0.69Mixed Models Analysis
Other Pre-specified

PTSD Checklist (PCL)

On the PCL participants first report an autobiographical narrative of a trauma, and subsequently rate symptom frequency (0 \[not at all\] - 4 \[everyday\]) and severity (0 \[not at all distressing\] - 4 \[extremely distressing\]) for all DSM-V PTSD symptoms within the past week. The PCL will be administered weekly to evaluate the association of PTSD symptoms with anger cognitions (as measured by the DAR) over the course of the group. Total score ranges from 0 to 80, with higher scores reflecting greater impairment.

Time frame: pre-treatment (baseline), post-treatment (12 weeks)

Population: Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyPTSD Checklist (PCL)Baseline58.8 units on a scaleStandard Deviation 13.2
Cognitive Behavioral TherapyPTSD Checklist (PCL)Post-treatment56.3 units on a scaleStandard Deviation 16.4
Cognitive Behavioral TherapyPTSD Checklist (PCL)3 month follow-up57.2 units on a scaleStandard Deviation 16.2
Cognitive Behavioral TherapyPTSD Checklist (PCL)6 month follow-up56.1 units on a scaleStandard Deviation 15.1
Present Centered TherapyPTSD Checklist (PCL)6 month follow-up52.9 units on a scaleStandard Deviation 16.5
Present Centered TherapyPTSD Checklist (PCL)Baseline56.0 units on a scaleStandard Deviation 12.1
Present Centered TherapyPTSD Checklist (PCL)3 month follow-up52.9 units on a scaleStandard Deviation 17.7
Present Centered TherapyPTSD Checklist (PCL)Post-treatment50.8 units on a scaleStandard Deviation 17.5
Comparison: Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on PCL Total scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.p-value: 0.16Mixed Models Analysis
Other Pre-specified

The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)

The Adaptability Scale is an 8-item subscale of the CD-RISC that measures adaptability in the face of challenges (e.g., I am able to adapt when changes occur). Cronbach's alpha for the 8-item Adaptability scale was found to be .91 in a sample of 1981Veterans (Green et al, under review). One of the primary goals of the CBT-A intervention is to increase Veterans' behavioral repertoire and range of Activities by targeting maladaptive Thought Functions and Emotion Functions. The Adaptability scale of the CD-RISC will be included among the outcome measures as it may assess improvements in Thought Functions and Emotion Functions that underlie limitations to Activities and Participation. The Adaptability scale scores can range from 0 to 32, with higher scores reflecting better functioning.

Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Population: Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyThe Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)Baseline13.4 units on a scaleStandard Deviation 3.78
Cognitive Behavioral TherapyThe Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)Post-treatment13.5 units on a scaleStandard Deviation 3.54
Cognitive Behavioral TherapyThe Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)3 month follow-up13.2 units on a scaleStandard Deviation 3.37
Cognitive Behavioral TherapyThe Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)6 month follow-up12.4 units on a scaleStandard Deviation 3.18
Present Centered TherapyThe Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)6 month follow-up13.1 units on a scaleStandard Deviation 3.54
Present Centered TherapyThe Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)Baseline13.1 units on a scaleStandard Deviation 3.05
Present Centered TherapyThe Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)3 month follow-up13.4 units on a scaleStandard Deviation 3.52
Present Centered TherapyThe Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)Post-treatment13.8 units on a scaleStandard Deviation 3.54
p-value: 0.29Mixed Models Analysis
p-value: 0.44Mixed Models Analysis
p-value: 0.11Mixed Models Analysis
Other Pre-specified

The Alcohol Use Disorder Identification Test (AUDIT)

The AUDIT contains 10 multiple choice questions about behavior and symptoms related to alcohol consumption. Scale scores range from 0 to 40, with higher scores reflecting greater impairment. Scores over 8 reflect a strong likelihood of hazardous our harmful alcohol consumption.

Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Population: Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyThe Alcohol Use Disorder Identification Test (AUDIT)Baseline1.89 units on a scaleStandard Deviation 2.45
Cognitive Behavioral TherapyThe Alcohol Use Disorder Identification Test (AUDIT)Post-treatment2.11 units on a scaleStandard Deviation 2.42
Cognitive Behavioral TherapyThe Alcohol Use Disorder Identification Test (AUDIT)3 month follow-up1.72 units on a scaleStandard Deviation 2.11
Cognitive Behavioral TherapyThe Alcohol Use Disorder Identification Test (AUDIT)6 month follow-up1.83 units on a scaleStandard Deviation 2.33
Present Centered TherapyThe Alcohol Use Disorder Identification Test (AUDIT)6 month follow-up2.88 units on a scaleStandard Deviation 4.03
Present Centered TherapyThe Alcohol Use Disorder Identification Test (AUDIT)Baseline3.0 units on a scaleStandard Deviation 4.46
Present Centered TherapyThe Alcohol Use Disorder Identification Test (AUDIT)3 month follow-up3.06 units on a scaleStandard Deviation 4.25
Present Centered TherapyThe Alcohol Use Disorder Identification Test (AUDIT)Post-treatment2.94 units on a scaleStandard Deviation 4.23
p-value: 0.45Mixed Models Analysis
p-value: 0.55Mixed Models Analysis
p-value: 0.87Mixed Models Analysis
Other Pre-specified

The Drug Abuse Screening Test (DAST)

The DAST contains 20 yes/no questions about behavior and symptoms pertaining to substance use. Scale range is 0-20, with higher scores reflecting greater impairment.

Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks)

Population: Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed. For one participant (female, PCT), data was available only for 6 month follow-up.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral TherapyThe Drug Abuse Screening Test (DAST)Baseline2.46 units on a scaleStandard Deviation 4.24
Cognitive Behavioral TherapyThe Drug Abuse Screening Test (DAST)Post-treatment2.11 units on a scaleStandard Deviation 3.72
Cognitive Behavioral TherapyThe Drug Abuse Screening Test (DAST)3 month follow-up2.30 units on a scaleStandard Deviation 3.74
Cognitive Behavioral TherapyThe Drug Abuse Screening Test (DAST)6 month follow-up2.24 units on a scaleStandard Deviation 3.69
Present Centered TherapyThe Drug Abuse Screening Test (DAST)6 month follow-up1.80 units on a scaleStandard Deviation 2.15
Present Centered TherapyThe Drug Abuse Screening Test (DAST)Baseline1.27 units on a scaleStandard Deviation 1.88
Present Centered TherapyThe Drug Abuse Screening Test (DAST)3 month follow-up1.52 units on a scaleStandard Deviation 1.79
Present Centered TherapyThe Drug Abuse Screening Test (DAST)Post-treatment1.64 units on a scaleStandard Deviation 2.19
p-value: 0.49Mixed Models Analysis
p-value: 0.7Mixed Models Analysis
p-value: 0.45Mixed Models Analysis

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