Clinical trial NCT02233517: Group CBT for Aggression in Veterans
Official title: Group Cognitive Behavioral Therapy for Anger and Aggression in Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggression
Anger
Posttraumatic Stress Disorder
Keywords: Veterans
Cognitive-Behavioral Therapy
Aggression
Anger
Posttraumatic Stress Disorder
Combat Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-09-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression (Olatunji, Ciesielski, \& Tolin, 2010), and U.S. Iraq/Afghanistan-era Veterans report that controlling anger and aggressive urges are primary readjustment concerns (Sayer et al, 2010). Trauma-related anger and aggression are associated with functional impairments that significantly limit community reintegration (Rodriguez, Holowka, \& Marx, 2012) and that may persist for decades (Koenen et al, 2003). As more troops return from multiple deployments to Iraq and Afghanistan, there is an urgent and growing need for the development and testing of psychosocial treatment for anger and aggression in combat Veterans with PTSD. VA clinicians are doing their best to be responsive to Veteran's needs by offering anger management treatment to Veterans: A survey of clinical practices within the VA found that 35-65% of VA PTSD specialists report providing anger management to their patients (Rosen et al., 2004). Yet to date only one randomized clinical trial (RCT), published in 1997, has investigated the efficacy of treatment of anger and aggression in Veterans with PTSD (Chemtob et al., 1997).

A recent review noted that most researchers who have examined the effects of anger management interventions have not done so as part of a systematic program of research (DiGiuseppe and Tafrate, 2003). The proposed CDA-2 application outlines Training and Mentoring Plans that will provide the applicant with the foundation to establish a career systematically developing, testing, and refining treatments for PTSD-related anger and aggression in Veterans. The following specific Training Goals have been formulated: 1) To acquire the advanced skills in the development and evaluation of clinical interventions necessary to begin an independent research career within the VA; 2) To develop greater expertise in delivery of behavioral interventions to improve functional outcomes and community reintegration in Veterans with PTSD, anger problems, and aggression; 3) To acquire expertise in the development and evaluation of treatment innovations to help Veterans generalize treatment gains beyond the therapy setting; 4) To increase understanding of rehabilitation theory and methods in treatment practices and research; and 5) To achieve critical professional development milestones, including submission of a Merit Review proposal based on the pilot data generated from the CDA-2 project.

The Research Plan proposes a pilot feasibility trial for an RCT of Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A). CBT-A is a 12-week manualized group treatment protocol that has been designed to address the specific needs of combat Veterans whose PTSD-related anger and aggression interfere with effective community reintegration. The group was implemented with 4 male Vietnam Veterans with severe combat-related PTSD who were referred for anger management treatment, and preliminary data were promising. The active comparison treatment for the pilot RCT will be group Present-Centered Therapy (PCT), a manualized treatment for PTSD that controls for treatment time, social support, and instillation of hope. The proposed research project will address the following Specific Aims: Aim 1: Characterize the differential effects of group CBT-A and group PCT on anger, aggression, and anger/aggression-related limitations to psychosocial functioning and community reintegration in combat Veterans with PTSD; and Aim 2: Evaluate study feasibility and treatment delivery procedures of an RCT comparing CBT-A to a PCT comparison condition. The results generated will guide the design of a full RCT to be funded by the end of the CDA-2 funding period. The research, training, and mentoring plans outlined here will provide the foundation for the PI's independent research career developing a systematic program of research in the treatment of anger and aggression among combat Veterans with PTSD. The availability of empirically-supported anger treatment would benefit the many Veterans with PTSD who return from combat reporting problems with anger and aggression.

Eligibility criteria: Inclusion Criteria:

A Veteran will meet criteria for inclusion if he/she meets all of the following criteria:

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

Exclusion Criteria:

A Veteran will be excluded from participation if he/she:

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

Primary outcomes:
measure: Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.
timeFrame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
measure: 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
timeFrame: pre-treatment (baseline), weekly treatment sessions, post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
measure: Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.
timeFrame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
Secondary outcomes:
measure: Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.
timeFrame: pre-treatment (baseline), post-treatment (12 weeks)
measure: 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.
timeFrame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
measure: Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.
timeFrame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
measure: The McMaster Family Assessment Device (FAD)
timeFrame: pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatment
Other outcomes:
measure: The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
measure: PTSD Checklist (PCL)
timeFrame: pre-treatment (baseline), post-treatment (12 weeks)
measure: The Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)
measure: The Drug Abuse Screening Test (DAST)
timeFrame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks)
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Elizabeth E Van Voorhees, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Van 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.
citation: Van 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.
citation: Ulmer 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.
citation: Van 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.
citation: Tye 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.