Trial Outcomes & Findings for Group CBT for Aggression in Veterans (NCT NCT02233517)

Last Updated: 2019-05-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

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

Results posted on

2019-05-31

Participant Flow

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

Participant milestones

Participant milestones
Measure	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 program, provides an 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. Cognitive Behavioral Therapy: 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.	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". Consistent with recommendations in the PCT manual, training will emphasize the approach rather than specific interventions.
Overall Study STARTED	19	17
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Group CBT for Aggression in Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Therapy n=19 Participants 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.	Present Centered Therapy n=17 Participants 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.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	50.8 years STANDARD_DEVIATION 11.7 • n=5 Participants	52.6 years STANDARD_DEVIATION 12.3 • n=7 Participants	51.6 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=18 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up. Baseline	0.50 units on a scale Standard Deviation 0.99	1.24 units on a scale Standard Deviation 4.13
Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up. post-treatment	0.22 units on a scale Standard Deviation 0.73	1.06 units on a scale Standard Deviation 4.12
Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up. 3-month follow-up	0.61 units on a scale Standard Deviation 1.50	1.19 units on a scale Standard Deviation 4.23
Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up. 6-month follow-up	0.94 units on a scale Standard Deviation 2.04	1.18 units on a scale Standard Deviation 4.11

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=19 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
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 post-treatment	34.6 units on a scale Standard Deviation 14.2	36.8 units on a scale Standard Deviation 14.6
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 baseline	40.2 units on a scale Standard Deviation 12.6	41.2 units on a scale Standard Deviation 10.4
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 3 month follow-up	35.8 units on a scale Standard Deviation 13.2	38.2 units on a scale Standard Deviation 13.9
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 6 month follow-up	35.5 units on a scale Standard Deviation 13.4	36.1 units on a scale Standard Deviation 12.7

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=11 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up. baseline	74.2 units on a scale Standard Deviation 4.6	75.9 units on a scale Standard Deviation 3.1
Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up. post-treatment	74.3 units on a scale Standard Deviation 5.0	76.1 units on a scale Standard Deviation 3.5
Change 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-up	74.8 units on a scale Standard Deviation 3.3	76.3 units on a scale Standard Deviation 3.0
Change 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-up	74.7 units on a scale Standard Deviation 2.6	76.1 units on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=17 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=16 Participants 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 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.
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment. Baseline, Extent of Participation	38.4 units on a scale Standard Deviation 6.3	37.9 units on a scale Standard Deviation 7.9
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment. Baseline, Perceived Limitations	41.1 units on a scale Standard Deviation 3.5	41.0 units on a scale Standard Deviation 4.6
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment. Post-treatment, Perceived Limitations	40.7 units on a scale Standard Deviation 3.2	41.1 units on a scale Standard Deviation 5.9
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment. Post-treatment, Extent of Participation	37.7 units on a scale Standard Deviation 5.8	39.5 units on a scale Standard Deviation 8.5
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment. Baseline, Satisfacation	41.4 units on a scale Standard Deviation 3.6	40.7 units on a scale Standard Deviation 3.4
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment. Post-treatment, Satisfaction	41.6 units on a scale Standard Deviation 3.7	41.6 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=18 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
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. 3 month follow-up	20.1 units on a scale Standard Deviation 9.4	22.4 units on a scale Standard Deviation 8.2
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. Baseline	19.3 units on a scale Standard Deviation 8.3	24.6 units on a scale Standard Deviation 7.3
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. Post-treatment	21.6 units on a scale Standard Deviation 9.0	20.7 units on a scale Standard Deviation 9.7
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. 6 month follow-up	22.0 units on a scale Standard Deviation 8.7	22.3 units on a scale Standard Deviation 7.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=18 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up. Post-treatment	48.5 units on a scale Standard Deviation 12.7	52.7 units on a scale Standard Deviation 14.9
Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up. Baseline	47.7 units on a scale Standard Deviation 10.7	53.4 units on a scale Standard Deviation 15.4
Change 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-up	50.5 units on a scale Standard Deviation 13.2	54.8 units on a scale Standard Deviation 14.1
Change 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-up	49.2 units on a scale Standard Deviation 10.7	55.8 units on a scale Standard Deviation 14.7

SECONDARY outcome

Timeframe: pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatment

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=18 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
The McMaster Family Assessment Device (FAD) Baseline	2.81 units on a scale Standard Deviation 0.61	2.50 units on a scale Standard Deviation 0.44
The McMaster Family Assessment Device (FAD) Post-treatment	2.72 units on a scale Standard Deviation 0.49	2.60 units on a scale Standard Deviation 0.51
The McMaster Family Assessment Device (FAD) 3 month follow-up	2.89 units on a scale Standard Deviation 0.52	2.58 units on a scale Standard Deviation 0.51
The McMaster Family Assessment Device (FAD) 6 month follow-up	2.86 units on a scale Standard Deviation 0.48	2.49 units on a scale Standard Deviation 0.65

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=18 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC) Baseline	13.4 units on a scale Standard Deviation 3.78	13.1 units on a scale Standard Deviation 3.05
The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC) Post-treatment	13.5 units on a scale Standard Deviation 3.54	13.8 units on a scale Standard Deviation 3.54
The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC) 3 month follow-up	13.2 units on a scale Standard Deviation 3.37	13.4 units on a scale Standard Deviation 3.52
The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC) 6 month follow-up	12.4 units on a scale Standard Deviation 3.18	13.1 units on a scale Standard Deviation 3.54

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=18 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
PTSD Checklist (PCL) Baseline	58.8 units on a scale Standard Deviation 13.2	56.0 units on a scale Standard Deviation 12.1
PTSD Checklist (PCL) Post-treatment	56.3 units on a scale Standard Deviation 16.4	50.8 units on a scale Standard Deviation 17.5
PTSD Checklist (PCL) 3 month follow-up	57.2 units on a scale Standard Deviation 16.2	52.9 units on a scale Standard Deviation 17.7
PTSD Checklist (PCL) 6 month follow-up	56.1 units on a scale Standard Deviation 15.1	52.9 units on a scale Standard Deviation 16.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=18 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
The Alcohol Use Disorder Identification Test (AUDIT) 3 month follow-up	1.72 units on a scale Standard Deviation 2.11	3.06 units on a scale Standard Deviation 4.25
The Alcohol Use Disorder Identification Test (AUDIT) Baseline	1.89 units on a scale Standard Deviation 2.45	3.0 units on a scale Standard Deviation 4.46
The Alcohol Use Disorder Identification Test (AUDIT) Post-treatment	2.11 units on a scale Standard Deviation 2.42	2.94 units on a scale Standard Deviation 4.23
The Alcohol Use Disorder Identification Test (AUDIT) 6 month follow-up	1.83 units on a scale Standard Deviation 2.33	2.88 units on a scale Standard Deviation 4.03

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=18 Participants Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. 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 (Chemtob et al., 1997). 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.	Present Centered Therapy n=17 Participants 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 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.
The Drug Abuse Screening Test (DAST) Baseline	2.46 units on a scale Standard Deviation 4.24	1.27 units on a scale Standard Deviation 1.88
The Drug Abuse Screening Test (DAST) Post-treatment	2.11 units on a scale Standard Deviation 3.72	1.64 units on a scale Standard Deviation 2.19
The Drug Abuse Screening Test (DAST) 3 month follow-up	2.30 units on a scale Standard Deviation 3.74	1.52 units on a scale Standard Deviation 1.79
The Drug Abuse Screening Test (DAST) 6 month follow-up	2.24 units on a scale Standard Deviation 3.69	1.80 units on a scale Standard Deviation 2.15

Adverse Events

Cognitive Behavioral Therapy

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Present Centered Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive Behavioral Therapy n=19 participants at risk 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 program, provides an 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. Cognitive Behavioral Therapy: 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.	Present Centered Therapy n=17 participants at risk 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". Consistent with recommendations in the PCT manual, training will emphasize the approach rather than specific interventions.
Respiratory, thoracic and mediastinal disorders Diagnosed with cancer	5.3% 1/19 • Number of events 1 • AE data were collected from baseline to the 6-month posttreatment visit, which is about 10 months.	0.00% 0/17 • AE data were collected from baseline to the 6-month posttreatment visit, which is about 10 months.
Respiratory, thoracic and mediastinal disorders Hospitalization	0.00% 0/19 • AE data were collected from baseline to the 6-month posttreatment visit, which is about 10 months.	5.9% 1/17 • Number of events 1 • AE data were collected from baseline to the 6-month posttreatment visit, which is about 10 months.
Eye disorders Hospitalization	5.3% 1/19 • Number of events 1 • AE data were collected from baseline to the 6-month posttreatment visit, which is about 10 months.	0.00% 0/17 • AE data were collected from baseline to the 6-month posttreatment visit, which is about 10 months.

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Van Voorhees

VAORD

Phone: (919) 286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place