Treatment of trauma related anger in operation enduring freedom, operation Iraqi freedom, and operation New Dawn veterans: Rationale and study protocol.

Contemporary Clinical Trials Communications 12 (2018) 26–31 Contents lists available at ScienceDirect Contemporary Clinical Trials Communications journal homepage: www.elsevier.com/locate/conctc Treatment of trauma related anger in operation enduring freedom, operation Iraqi freedom, and operation New Dawn veterans: Rationale and study protocol☆ T M. Tracie Sheaa,b,∗, Jennifer Lamberta,b, Madhavi K. Reddyc, Candice Presseaub, Elizabeth Sevina, Robert L. Stoutd a Department of Veterans Affairs Medical Center, 830 Chalkstone Avenue, Providence, RI, 02908, USA Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, 02912, USA Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, 1941 East Road, Houston, TX, 77054, USA d Decision Sciences Institute, 1005 Main Street, Pawtucket, RI, 02860, USA b c A R T I C LE I N FO A B S T R A C T Keywords: Veteran Anger Aggression Trauma Treatment Background: Problems with anger and aggression are highly prevalent in Veterans of multiple war eras, including the most recent conflicts in Afghanistan (Operation Enduring Freedom; OEF) and Iraq (Operation Iraqi Freedom; OIF). The consequences of these problems, such as increased rates of divorce, domestic violence, occupational instability, arrests and incarceration, are often devastating. Despite the seriousness of these problems, relatively little is known about effective treatments for anger in Veterans. Method and design: This paper describes the rationale and study protocol of a randomized controlled trial comparing an adapted cognitive behavioral intervention (CBI) with an active control condition (supportive intervention, SI) for the treatment of anger problems in OEF/OIF Veterans. The sample includes 92 OEF/OIF Veterans, randomized to CBI or SI. Both treatments include 12 weekly, 75-min individual sessions. Participants are assessed at baseline, after sessions 4 and 8, at post-treatment, and at 3 and 6 months post-treatment. Primary outcomes are reduction in anger and aggression; secondary outcomes are improved functioning and quality of life. We hypothesize that CBI will be associated with significantly more improvement than SI on primary and secondary measures. Discussion: Findings from this study will help to address the gap in evidence for effective treatments for anger in Veterans. The use of an active control condition will provide a stringent test of the effects of CBI beyond that of common factors of psychotherapy such as therapeutic relationship, mobilization of hope, and support. Findings have the potential to improve treatment outcomes for Veterans struggling with post-deployment anger problems. 1. Introduction Associations between combat and post-war problems with anger are well documented. Increased rates of anger have been shown among Veterans of multiple wars, including World War II [12,15], the Vietnam War [18,20], and more recently, the Afghanistan (Operation Enduring Freedom – OEF) and Iraq (Operation Iraqi Freedom – OIF) conflicts [13,14,29]. Reported rates of problematic anger or aggression in individuals having served in OEF/OIF have been as high as 57% in combat Veterans receiving VA medical care [29], and 67% in active duty soldiers 4 months after return from deployment [39]. The consequences of these problems can be devastating, including increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning [18]. Cognitive behavioral treatments for anger have been shown to be effective in civilian samples [2,7,8], but given the unique aspects of military training and combat that contribute to problematic anger, these findings cannot be assumed to generalize to Veterans. Military training involves responding to threat with aggression, aggression is powerfully re-enforced by survival, and repeated exposure to life threatening situations such as occurs in a warzone can result in a lower ☆ This research was supported by Grant Number 5I01RX001146, from the Department of Veterans Affairs, Rehabilitation Research and Development Program. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. ∗ Corresponding author. Veterans Affairs Medical Center, 830 Chalkstone Avenue, Bldg. 32, Providence, RI, 02908, USA. E-mail address: (M.T. Shea). https://doi.org/10.1016/j.conctc.2018.08.011 Received 30 March 2018; Received in revised form 10 August 2018; Accepted 23 August 2018 Available online 24 August 2018 2451-8654/ Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/BY-NC-ND/4.0/). Contemporary Clinical Trials Communications 12 (2018) 26–31 M.T. Shea et al. were scheduled for an interview to further describe the study, obtain written informed consent for study participation, and to determine eligibility according to inclusion and exclusion criteria. Participants determined to be eligible then completed the rest of the baseline assessment, including additional interview and self-report measures. Participants were asked if they were willing to have a collateral reporter (significant other or other person with whom they had a minimum of 5 h of contact per week) to provide an additional perspective on change following treatment. Participants who agreed were asked to sign an additional consent to provide permission to contact the identified individual. Collaterals were fully informed of the study requirements and asked to sign informed consent. Participants were randomly assigned to CBI or SI using urn randomization, a stratified randomization technique that systematically biases the randomization in favor of balance among the treatment condition on stratification variables [36,38]. Gender, PTSD diagnosis, and time since return from deployment (≤2 years vs. > 2 years) were used as balancing factors. threshold for perception of threat and for anger reactions. Despite the seriousness of anger problems among Veterans, little is known about effective treatments in this population. The few controlled studies to date have either had small sample sizes [3,32], or no control group [11,21,23]. We conducted a pilot study [32] of a cognitive behavioral treatment [24] that we adapted for OEF/OIF Veterans. This is the only study of anger treatment to our knowledge that has focused exclusively on OEF/OIF Veterans. Promising findings from this pilot led to the initiation of the current study. The primary aims of this study (ClinicalTrials.gov ID: NCT02157779) are to test the efficacy of the adapted treatment, Cognitive Behavioral Intervention (CBI), on primary outcome measures of anger and aggression, and on secondary measures of functioning, quality of life, and PTSD symptoms at post-treatment and at 3 and 6 month post-treatment assessments. We hy (...truncated)