AggressionCBT-ANCT02233517
Group CBT for Aggression in Veterans
A study testing Cognitive Behavioral Therapy and Present Centered Therapy in people with Aggression and Anger, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S. Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among their top priorities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggression, Anger, Posttraumatic Stress Disorder
- What is being tested?
- Cognitive Behavioral Therapy and Present Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2015to 5 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A Veteran will meet criteria for inclusion if he/she meets all of the following criteria:
- Current PTSD based on the CAPS;
- served in combat (regardless of era or country of combat service);
- can speak and write fluent conversational English;
- at least 18 years of age;
- report problems with irritability, anger, or aggression within the past month. Problems with anger and aggression will be defined via the "rule of 4": Inclusion in the study will require a CAPS-V score > 2 on item 15 (E1), "irritable or angry and showed it in your behavior" item within the past month.
Who cannot join
- A Veteran will be excluded from participation if he/she:
- is expected to be unstable on his/her medication regimen during the study;
- currently meets criteria for Bipolar I Disorder or a primary psychotic disorder as determined by the Structured Clinical Interview for the DSM (most current version available) (SCID);
- is receiving (or plan to) other anger-management psychotherapy during the course of the study;
- will be undergoing empirically supported psychotherapy for PTSD during the treatment component of the study;
- meets criteria for substance dependence (other than nicotine) within the past month as determined by the SCID; or
- is determined to have moderate or severe impairment related to traumatic brain injury as measured by the Brief Traumatic Brain Injury Screen and consultation with the Veteran's provider.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Group Cognitive Behavioral Therapy for Anger and Aggression in Veterans With PTSD
Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S. Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among their top priorities. PTSD-related anger and aggression are associated with profound functional impairments, yet to date there are no empirically-supported treatments for Veterans with PTSD and aggression. Effective group treatment programs could improve functioning and facilitate community reintegration for these Veterans. Given that anger impedes progress in treatment of PTSD symptoms, group anger treatment could also improve Veterans' capacity to benefit from individually-administered empirically-supported therapy for PTSD such as prolonged exposure or cognitive processing therapy.
Read the detailed description
Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression (Olatunji, Ciesielski, \& Tolin, 2010), and U.S. Iraq/Afghanistan-era Veterans report that controlling anger and aggressive urges are primary readjustment concerns (Sayer et al, 2010). Trauma-related anger and aggression are associated with functional impairments that significantly limit community reintegration (Rodriguez, Holowka, \& Marx, 2012) and that may persist for decades (Koenen et al, 2003). As more troops return from multiple deployments to Iraq and Afghanistan, there is an urgent and growing need for the development and testing of psychosocial treatment for anger and aggression in combat Veterans with PTSD. VA clinicians are doing their best to be responsive to Veteran's needs by offering anger management treatment to Veterans: A survey of clinical practices within the VA found that 35-65% of VA PTSD specialists report providing anger management to their patients (Rosen et al., 2004). Yet to date only one randomized clinical trial (RCT), published in 1997, has investigated the efficacy of treatment of anger and aggression in Veterans with PTSD (Chemtob et al., 1997).
A recent review noted that most researchers who have examined the effects of anger management interventions have not done so as part of a systematic program of research (DiGiuseppe and Tafrate, 2003). The proposed CDA-2 application outlines Training and Mentoring Plans that will provide the applicant with the foundation to establish a career systematically developing, testing, and refining treatments for PTSD-related anger and aggression in Veterans. The following specific Training Goals have been formulated: 1) To acquire the advanced skills in the development and evaluation of clinical interventions necessary to begin an independent research career within the VA; 2) To develop greater expertise in delivery of behavioral interventions to improve functional outcomes and community reintegration in Veterans with PTSD, anger problems, and aggression; 3) To acquire expertise in the development and evaluation of treatment innovations to help Veterans generalize treatment gains beyond the therapy setting; 4) To increase understanding of rehabilitation theory and methods in treatment practices and research; and 5) To achieve critical professional development milestones, including submission of a Merit Review proposal based on the pilot data generated from the CDA-2 project.
The Research Plan proposes a pilot feasibility trial for an RCT of Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A). CBT-A is a 12-week manualized group treatment protocol that has been designed to address the specific needs of combat Veterans whose PTSD-related anger and aggression interfere with effective community reintegration. The group was implemented with 4 male Vietnam Veterans with severe combat-related PTSD who were referred for anger management treatment, and preliminary data were promising. The active comparison treatment for the pilot RCT will be group Present-Centered Therapy (PCT), a manualized treatment for PTSD that controls for treatment time, social support, and instillation of hope. The proposed research project will address the following Specific Aims: Aim 1: Characterize the differential effects of group CBT-A and group PCT on anger, aggression, and anger/aggression-related limitations to psychosocial functioning and community reintegration in combat Veterans with PTSD; and Aim 2: Evaluate study feasibility and treatment delivery procedures of an RCT comparing CBT-A to a PCT comparison condition. The results generated will guide the design of a full RCT to be funded by the end of the CDA-2 funding period. The research, training, and mentoring plans outlined here will provide the foundation for the PI's independent research career developing a systematic program of research in the treatment of anger and aggression among combat Veterans with PTSD. The availability of empirically-supported anger treatment would benefit the many Veterans with PTSD who return from combat reporting problems with anger and aggression.
- Conditions
- Aggression, Anger, Posttraumatic Stress Disorder
- Being tested
- Cognitive Behavioral Therapy, Present Centered Therapy
- Keywords
- Veterans, Cognitive-Behavioral Therapy, Aggression, Anger, Posttraumatic Stress Disorder, Combat Disorders
- Medical subject headings
- Aggression, Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Cognitive Behavioral Therapy provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning.
Present Centered TherapyBehavioural
Present Centered Therapy utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the "here-and-now" to support patients in their efforts to improve functioning.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy |
| Present Centered Therapy | Active comparator | 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. Receives: Behavioral: Present Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.
Physically aggressive behaviors including throwing something at someone, pushing, grabbing, shoving, slapping, kicking, biting, hitting, beating up, threatening with a gun or knife, or using a gun or knife on someone. Scale range 0 (never) to 6 (more than 20 times) over past 30 days.
Measured: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
Change in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up
The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. The scale will be administered weekly to provide information about the pattern of change in anger- and aggression-related cognitions over the course of the group. Scores range from 0 to 56, with higher scores reflecting greater impairment.
Measured: pre-treatment (baseline), weekly treatment sessions, post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.
The NAS is a measure anger and coping that indexes four aspects of the experience of anger: Cognitive, Arousal, Behavior, and Anger Regulation. The T-score for the total NAS is used as the outcome, with a range of 0 to 100. Higher scores reflect greater impairment.
Measured: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
Secondary outcomes (4)
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.
The computer-adaptive version of the CRIS was developed specifically to assess the ICF domain of Participation in Veterans. The Perceived Limitations to Participation subscale assesses Veterans' perceived limitations in participation, and includes items such as "I felt that I easily lost control of my feelings". The Extent of Participation subscale assesses how often Veterans experience a challenge in participation, and includes items such as "How often did you get together with friends?" The Satisfaction with Participation subscale assesses Veterans' level of satisfaction with participation, and includes items such as "How satisfied were you with your daily accomplishments?" Each of the scales has a range of 0-100, with higher scores reflecting better functioning.
Measured: pre-treatment (baseline), post-treatment (12 weeks)
Change in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.
The 12-item, self-report version of the WHO-DAS 2.0 will be administered to assess the impact of anger and aggression on broad functioning, as well as across six ICF functioning domains of mobility, self-care, getting along, life activities (household and work) and participation. In addition to the outcome time frame listed above, the WHO-DAS 2.0 will be administered weekly to collect exploratory information about Veterans' perceptions of how their overall functioning changes over the course of the group. The scale range is 0 to 48, with higher scores reflecting greater impairment.
Measured: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.
The IPF is an 80-item self-report measure that assesses functioning over the past 30 days in the following domains: romantic relationships; family relationships; work; friendships and socializing; parenting; academic pursuits; and self-care. The IPF Total score will be used in these analyses. Scores range from 11 to 80, with higher scores reflecting greater functional impairment.
Measured: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
The McMaster Family Assessment Device (FAD)
The FAD is a 60-item scale that consists of statements about families to which respondents indicated agreement or disagreement on a 4-point scale. It yields a General Functioning (GF) score, as well as indices of 6 areas of family activity: problem solving; communication; roles; affective responses; affective involvement; and behavioral control. The General Functioning Scale will be used for this outcome. The General Functional Scale scores range from 1-4, with higher scores reflect greater impairment.
Measured: pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study start9 Feb 2015
- Primary completion5 Jul 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AggressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elizabeth E Van Voorhees, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233517
- Sponsor's protocol ID
- D1298-W
- Other IDs
- 1IK2RX001298-01A2
- Acronym
- CBT-A
- Status last verified
- May 2019
- First submitted
- 18 Aug 2014
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dennis PA, Dennis NM, Van Voorhees EE, Calhoun PS, Dennis MF, Beckham JC. Moral transgression during the Vietnam War: a path analysis of the psychological impact of veterans' involvement in wartime atrocities. Anxiety Stress Coping. 2017 Mar;30(2):188-201. doi: 10.1080/10615806.2016.1230669. Epub 2016 Sep 19.
PubMed 27580161Van Voorhees EE, Dennis PA, Neal LC, Hicks TA, Calhoun PS, Beckham JC, Elbogen EB. Posttraumatic Stress Disorder, Hostile Cognitions, and Aggression in Iraq/Afghanistan Era Veterans. Psychiatry. 2016 Spring;79(1):70-84. doi: 10.1080/00332747.2015.1123593.
PubMed 27187514Van Voorhees EE, Dennis PA, Elbogen EB, Clancy CP, Hertzberg MA, Beckham JC, Calhoun PS. Personality assessment inventory internalizing and externalizing structure in veterans with posttraumatic stress disorder: associations with aggression. Aggress Behav. 2014 Nov-Dec;40(6):582-92. doi: 10.1002/ab.21554. Epub 2014 Aug 16.
PubMed 25131806Ulmer CS, Van Voorhees E, Germain AE, Voils CI, Beckham JC; VA Mid-Atlantic Mental Illness Research Education and Clinical Center Registry Workgroup. A Comparison of Sleep Difficulties among Iraq/Afghanistan Theater Veterans with and without Mental Health Diagnoses. J Clin Sleep Med. 2015 Sep 15;11(9):995-1005. doi: 10.5664/jcsm.5012.
PubMed 26094928Van Voorhees EE, Beckham JC. Advancements in treating intimate partner violence in veterans. J Clin Psychiatry. 2015 Jun;76(6):e826-7. doi: 10.4088/JCP.14com09556. No abstract available.
PubMed 26132696Tye S, Van Voorhees E, Hu C, Lineberry T. Preclinical perspectives on posttraumatic stress disorder criteria in DSM-5. Harv Rev Psychiatry. 2015 Jan-Feb;23(1):51-8. doi: 10.1097/HRP.0000000000000035.
PubMed 25563569
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Cognitive Behavioral Therapy for Anger and Aggression in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT02233517
- Acronym / sponsor ID
- CBT-A / D1298-W
- Conditions
- Aggression, Anger, Posttraumatic Stress Disorder
- Keywords
- Veterans, Cognitive-Behavioral Therapy, Aggression, Anger, Posttraumatic Stress Disorder, Combat Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Feb 2015 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S. Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among their top priorities. PTSD-related anger and aggression are associated with profound functional impairments, yet to date there are no empirically-supported treatments for Veterans with PTSD and aggression. Effective group treatment programs could improve functioning and facilitate community reintegration for these Veterans. Given that anger impedes progress in treatment of PTSD symptoms, group anger treatment could also improve Veterans' capacity to benefit from individually-administered empirically-supported therapy for PTSD such as prolonged exposure or cognitive processing therapy.
Detailed description
Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression (Olatunji, Ciesielski, \& Tolin, 2010), and U.S. Iraq/Afghanistan-era Veterans report that controlling anger and aggressive urges are primary readjustment concerns (Sayer et al, 2010). Trauma-related anger and aggression are associated with functional impairments that significantly limit community reintegration (Rodriguez, Holowka, \& Marx, 2012) and that may persist for decades (Koenen et al, 2003). As more troops return from multiple deployments to Iraq and Afghanistan, there is an urgent and growing need for the development and testing of psychosocial treatment for anger and aggression in combat Veterans with PTSD. VA clinicians are doing their best to be responsive to Veteran's needs by offering anger management treatment to Veterans: A survey of clinical practices within the VA found that 35-65% of VA PTSD specialists report providing anger management to their patients (Rosen et al., 2004). Yet to date only one randomized clinical trial (RCT), published in 1997, has investigated the efficacy of treatment of anger and aggression in Veterans with PTSD (Chemtob et al., 1997).
A recent review noted that most researchers who have examined the effects of anger management interventions have not done so as part of a systematic program of research (DiGiuseppe and Tafrate, 2003). The proposed CDA-2 application outlines Training and Mentoring Plans that will provide the applicant with the foundation to establish a career systematically developing, testing, and refining treatments for PTSD-related anger and aggression in Veterans. The following specific Training Goals have been formulated: 1) To acquire the advanced skills in the development and evaluation of clinical interventions necessary to begin an independent research career within the VA; 2) To develop greater expertise in delivery of behavioral interventions to improve functional outcomes and community reintegration in Veterans with PTSD, anger problems, and aggression; 3) To acquire expertise in the development and evaluation of treatment innovations to help Veterans generalize treatment gains beyond the therapy setting; 4) To increase understanding of rehabilitation theory and methods in treatment practices and research; and 5) To achieve critical professional development milestones, including submission of a Merit Review proposal based on the pilot data generated from the CDA-2 project.
The Research Plan proposes a pilot feasibility trial for an RCT of Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A). CBT-A is a 12-week manualized group treatment protocol that has been designed to address the specific needs of combat Veterans whose PTSD-related anger and aggression interfere with effective community reintegration. The group was implemented with 4 male Vietnam Veterans with severe combat-related PTSD who were referred for anger management treatment, and preliminary data were promising. The active comparison treatment for the pilot RCT will be group Present-Centered Therapy (PCT), a manualized treatment for PTSD that controls for treatment time, social support, and instillation of hope. The proposed research project will address the following Specific Aims: Aim 1: Characterize the differential effects of group CBT-A and group PCT on anger, aggression, and anger/aggression-related limitations to psychosocial functioning and community reintegration in combat Veterans with PTSD; and Aim 2: Evaluate study feasibility and treatment delivery procedures of an RCT comparing CBT-A to a PCT comparison condition. The results generated will guide the design of a full RCT to be funded by the end of the CDA-2 funding period. The research, training, and mentoring plans outlined here will provide the foundation for the PI's independent research career developing a systematic program of research in the treatment of anger and aggression among combat Veterans with PTSD. The availability of empirically-supported anger treatment would benefit the many Veterans with PTSD who return from combat reporting problems with anger and aggression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive-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 | Active comparator | Behavioral: Present Centered TherapyPresent 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current PTSD based on the CAPS;
- served in combat (regardless of era or country of combat service);
- can speak and write fluent conversational English;
- at least 18 years of age;
- report problems with irritability, anger, or aggression within the past month. Problems with anger and aggression will be defined via the "rule of 4": Inclusion in the study will require a CAPS-V score > 2 on item 15 (E1), "irritable or angry and showed it in your behavior" item within the past month.
Key exclusion criteria (7 listed)
- is expected to be unstable on his/her medication regimen during the study;
- currently meets criteria for Bipolar I Disorder or a primary psychotic disorder as determined by the Structured Clinical Interview for the DSM (most current version available) (SCID);
- is receiving (or plan to) other anger-management psychotherapy during the course of the study;
- will be undergoing empirically supported psychotherapy for PTSD during the treatment component of the study;
- meets criteria for substance dependence (other than nicotine) within the past month as determined by the SCID; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyCognitive Behavioral Therapy provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning. | Behavioural | Cognitive Behavioral Therapy |
| Present Centered TherapyPresent Centered Therapy utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the "here-and-now" to support patients in their efforts to improve functioning. | Behavioural | Present Centered Therapy |
Primary outcome
Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.
Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
Physically aggressive behaviors including throwing something at someone, pushing, grabbing, shoving, slapping, kicking, biting, hitting, beating up, threatening with a gun or knife, or using a gun or knife on someone. Scale range 0 (never) to 6 (more than 20 times) over past 30 days.
Change in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up
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)
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.
Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.
Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
The NAS is a measure anger and coping that indexes four aspects of the experience of anger: Cognitive, Arousal, Behavior, and Anger Regulation. The T-score for the total NAS is used as the outcome, with a range of 0 to 100. Higher scores reflect greater impairment.
4 secondary outcomes
Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.
Time frame: pre-treatment (baseline), post-treatment (12 weeks)
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.
Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.
Time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
The McMaster Family Assessment Device (FAD)
Time frame: pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27580161Dennis PA, Dennis NM, Van Voorhees EE, Calhoun PS, Dennis MF, Beckham JC. Moral transgression during the Vietnam War: a path analysis of the psychological impact of veterans' involvement in wartime atrocities. Anxiety Stress Coping. 2017 Mar;30(2):188-201. doi: 10.1080/10615806.2016.1230669. Epub 2016 Sep 19.
- Background: PubMed 27187514Van Voorhees EE, Dennis PA, Neal LC, Hicks TA, Calhoun PS, Beckham JC, Elbogen EB. Posttraumatic Stress Disorder, Hostile Cognitions, and Aggression in Iraq/Afghanistan Era Veterans. Psychiatry. 2016 Spring;79(1):70-84. doi: 10.1080/00332747.2015.1123593.
- Background: PubMed 25131806Van Voorhees EE, Dennis PA, Elbogen EB, Clancy CP, Hertzberg MA, Beckham JC, Calhoun PS. Personality assessment inventory internalizing and externalizing structure in veterans with posttraumatic stress disorder: associations with aggression. Aggress Behav. 2014 Nov-Dec;40(6):582-92. doi: 10.1002/ab.21554. Epub 2014 Aug 16.
- Background: PubMed 26094928Ulmer CS, Van Voorhees E, Germain AE, Voils CI, Beckham JC; VA Mid-Atlantic Mental Illness Research Education and Clinical Center Registry Workgroup. A Comparison of Sleep Difficulties among Iraq/Afghanistan Theater Veterans with and without Mental Health Diagnoses. J Clin Sleep Med. 2015 Sep 15;11(9):995-1005. doi: 10.5664/jcsm.5012.
- Background: PubMed 26132696Van Voorhees EE, Beckham JC. Advancements in treating intimate partner violence in veterans. J Clin Psychiatry. 2015 Jun;76(6):e826-7. doi: 10.4088/JCP.14com09556. No abstract available.
- Background: PubMed 25563569Tye S, Van Voorhees E, Hu C, Lineberry T. Preclinical perspectives on posttraumatic stress disorder criteria in DSM-5. Harv Rev Psychiatry. 2015 Jan-Feb;23(1):51-8. doi: 10.1097/HRP.0000000000000035.
- Individual participant dataSharing planned: Undecided
Related trials for Aggression
Recruiting
Virtual Reality Intervention (VR-GINSO) for Reducing Aggression in Young Offenders
Aggression
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
Active, not recruiting
Manage Emotions to Reduce Aggression (MERA)
Stress Disorders, Post-Traumatic, Aggression
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Recruiting
Just-in-Time Coping Prompts for Reactive Digital Behavior in College Students
Emotional Regulation, Alcohol Drinking in College
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth E Van Voorhees, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Present Centered Therapy in people with Aggression and Anger, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up. (time frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233517, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019; AzTrials last refreshed its copy on 27 Oct 2026.