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Group CBT for Aggression in Veterans (CBT-A)

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ClinicalTrials.gov Identifier: NCT02233517
Recruitment Status : Completed
First Posted : September 8, 2014
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Aggression
Anger
Posttraumatic Stress Disorder
Interventions Behavioral: Cognitive Behavioral Therapy
Behavioral: Present Centered Therapy
Enrollment 66
Recruitment Details  
Pre-assignment Details 30 participants were excluded after enrollment: 13 did not meet inclusion criteria; 17 declined to participate or were lost to contact.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description 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 (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.
Period Title: Overall Study
Started 19 17
Completed 12 13
Not Completed 7 4
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy Total
Hide Arm/Group Description 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 (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 of all reporting groups
Overall Number of Baseline Participants 19 17 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  84.2%
13
  76.5%
29
  80.6%
>=65 years
3
  15.8%
4
  23.5%
7
  19.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 36 participants
50.8  (11.7) 52.6  (12.3) 51.6  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Female
5
  26.3%
6
  35.3%
11
  30.6%
Male
14
  73.7%
11
  64.7%
25
  69.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Hispanic or Latino
0
   0.0%
1
   5.9%
1
   2.8%
Not Hispanic or Latino
19
 100.0%
16
  94.1%
35
  97.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  57.9%
10
  58.8%
21
  58.3%
White
7
  36.8%
7
  41.2%
14
  38.9%
More than one race
1
   5.3%
0
   0.0%
1
   2.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 17 participants 36 participants
19
 100.0%
17
 100.0%
36
 100.0%
1.Primary Outcome
Title Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants 17 participants
0.50  (0.99) 1.24  (4.13)
post-treatment Number Analyzed 18 participants 17 participants
0.22  (0.73) 1.06  (4.12)
3-month follow-up Number Analyzed 18 participants 16 participants
0.61  (1.50) 1.19  (4.23)
6-month follow-up Number Analyzed 18 participants 17 participants
0.94  (2.04) 1.18  (4.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments Baseline to post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.44
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.52
Estimation Comments Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.
2.Primary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 19 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline Number Analyzed 17 participants 17 participants
40.2  (12.6) 41.2  (10.4)
post-treatment Number Analyzed 17 participants 17 participants
34.6  (14.2) 36.8  (14.6)
3 month follow-up Number Analyzed 17 participants 17 participants
35.8  (13.2) 38.2  (13.9)
6 month follow-up Number Analyzed 17 participants 17 participants
35.5  (13.4) 36.1  (12.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments 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.
Type of Statistical Test Superiority
Comments 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).
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 11 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 74.2  (4.6) 75.9  (3.1)
post-treatment 74.3  (5.0) 76.1  (3.5)
3 month follow-up 74.8  (3.3) 76.3  (3.0)
6 month follow-up 74.7  (2.6) 76.1  (3.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.16
Estimation Comments Baseline to post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.16
Estimation Comments Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.16
Estimation Comments Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.
4.Secondary Outcome
Title Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Last observation carried forward analyses used. Three participants did not have baseline measures, so were not included.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, Perceived Limitations 41.1  (3.5) 41.0  (4.6)
Post-treatment, Perceived Limitations 40.7  (3.2) 41.1  (5.9)
Baseline, Extent of Participation 38.4  (6.3) 37.9  (7.9)
Post-treatment, Extent of Participation 37.7  (5.8) 39.5  (8.5)
Baseline, Satisfacation 41.4  (3.6) 40.7  (3.4)
Post-treatment, Satisfaction 41.6  (3.7) 41.6  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-4.5 to -.002
Parameter Dispersion
Type: Standard Deviation
Value: 3.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-2.03 to 1.08
Parameter Dispersion
Type: Standard Deviation
Value: 2.09
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Satisfaction scale.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-2.30 to 1.14
Parameter Dispersion
Type: Standard Deviation
Value: 2.42
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 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.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 19.3  (8.3) 24.6  (7.3)
Post-treatment 21.6  (9.0) 20.7  (9.7)
3 month follow-up 20.1  (9.4) 22.4  (8.2)
6 month follow-up 22.0  (8.7) 22.3  (7.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments 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).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments The estimation parameter of 0.28 indicates that at each of the 16 time points, participants in the CBT arm had 0.28 point less of a decrease in disability than those in PCT arm.
6.Secondary Outcome
Title Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 47.7  (10.7) 53.4  (15.4)
Post-treatment 48.5  (12.7) 52.7  (14.9)
3 month follow-up 50.5  (13.2) 54.8  (14.1)
6 month follow-up 49.2  (10.7) 55.8  (14.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.71
Estimation Comments Baseline to post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.71
Estimation Comments Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.71
Estimation Comments Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.
7.Secondary Outcome
Title The McMaster Family Assessment Device (FAD)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.81  (0.61) 2.50  (0.44)
Post-treatment 2.72  (0.49) 2.60  (0.51)
3 month follow-up 2.89  (0.52) 2.58  (0.51)
6 month follow-up 2.86  (0.48) 2.49  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments Baseline to post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.006
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.17
Estimation Comments Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.
8.Other Pre-specified Outcome
Title The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 13.4  (3.78) 13.1  (3.05)
Post-treatment 13.5  (3.54) 13.8  (3.54)
3 month follow-up 13.2  (3.37) 13.4  (3.52)
6 month follow-up 12.4  (3.18) 13.1  (3.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments Baseline to post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.
9.Other Pre-specified Outcome
Title PTSD Checklist (PCL)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 58.8  (13.2) 56.0  (12.1)
Post-treatment 56.3  (16.4) 50.8  (17.5)
3 month follow-up 57.2  (16.2) 52.9  (17.7)
6 month follow-up 56.1  (15.1) 52.9  (16.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments 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 PTSD in PCT).
10.Other Pre-specified Outcome
Title The Alcohol Use Disorder Identification Test (AUDIT)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.89  (2.45) 3.0  (4.46)
Post-treatment 2.11  (2.42) 2.94  (4.23)
3 month follow-up 1.72  (2.11) 3.06  (4.25)
6 month follow-up 1.83  (2.33) 2.88  (4.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.37
Estimation Comments Baseline to post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.37
Estimation Comments Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.37
Estimation Comments Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.
11.Other Pre-specified Outcome
Title The Drug Abuse Screening Test (DAST)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description:
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 (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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants 16 participants
2.46  (4.24) 1.27  (1.88)
Post-treatment Number Analyzed 18 participants 16 participants
2.11  (3.72) 1.64  (2.19)
3 month follow-up Number Analyzed 18 participants 16 participants
2.30  (3.74) 1.52  (1.79)
6 month follow-up Number Analyzed 18 participants 17 participants
2.24  (3.69) 1.80  (2.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments Baseline to post-treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.
Time Frame AE data were collected from baseline to the 6-month posttreatment visit, which is about 10 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Behavioral Therapy Present Centered Therapy
Hide Arm/Group Description 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 (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.
All-Cause Mortality
Cognitive Behavioral Therapy Present Centered Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/17 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Behavioral Therapy Present Centered Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/19 (10.53%)      1/17 (5.88%)    
Eye disorders     
Hospitalization  [1]  1/19 (5.26%)  1 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Diagnosed with cancer  [2]  1/19 (5.26%)  1 0/17 (0.00%)  0
Hospitalization  [3]  0/19 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
[1]
Pt. was hospitalized after a botched eye surgery, not related to study participation
[2]
Participant was diagnosed with stage 4 lung cancer, unrelated to study participation
[3]
Pt. was hospitalized due to a collapsed lung, not related to study participation.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cognitive Behavioral Therapy Present Centered Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/17 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Elizabeth Van Voorhees
Organization: VAORD
Phone: (919) 286-0411 ext 6435
Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02233517     History of Changes
Other Study ID Numbers: D1298-W
1IK2RX001298-01A2 ( U.S. NIH Grant/Contract )
First Submitted: August 18, 2014
First Posted: September 8, 2014
Results First Submitted: June 25, 2018
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019