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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

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.

Condition or disease Intervention/treatment Phase
Aggression Anger Posttraumatic Stress Disorder Behavioral: Cognitive Behavioral Therapy Behavioral: Present Centered Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Cognitive Behavioral Therapy for Anger and Aggression in Veterans With PTSD
Actual Study Start Date : February 9, 2015
Actual Primary Completion Date : July 5, 2017
Actual Study Completion Date : July 5, 2017

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol 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.
Behavioral: Cognitive Behavioral Therapy
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.

Active Comparator: Present Centered Therapy
Present Centered Therapy (PCT) is an active, manualized treatment comparison condition for psychotherapy trials. PCT is designed to control for nonspecific factors of therapy such as contact with a trained therapist, rationale for treatment, and instillation of expectancy for therapeutic gains. The therapeutic approach was drawn from Yalom's group therapy model, which utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the "here-and-now". 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.
Behavioral: Present Centered Therapy
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. Change in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up. [ Time Frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks) ]
    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.

  3. 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 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.

  4. The McMaster Family Assessment Device (FAD) [ Time Frame: pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatment ]
    The FAD is a 60-item scale that consists of statements about families to which respondents indicated agreement or disagreement on a 4-point scale. It yields a General Functioning (GF) score, as well as indices of 6 areas of family activity: problem solving; communication; roles; affective responses; affective involvement; and behavioral control. The General Functioning Scale will be used for this outcome. The General Functional Scale scores range from 1-4, with higher scores reflect greater impairment.


Other Outcome Measures:
  1. The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks) ]
    The Adaptability Scale is an 8-item subscale of the CD-RISC that measures adaptability in the face of challenges (e.g., "I am able to adapt when changes occur"). Cronbach's alpha for the 8-item Adaptability scale was found to be .91 in a sample of 1981Veterans (Green et al, under review). One of the primary goals of the CBT-A intervention is to increase Veterans' behavioral repertoire and range of Activities by targeting maladaptive Thought Functions and Emotion Functions. The Adaptability scale of the CD-RISC will be included among the outcome measures as it may assess improvements in Thought Functions and Emotion Functions that underlie limitations to Activities and Participation. The Adaptability scale scores can range from 0 to 32, with higher scores reflecting better functioning.

  2. PTSD Checklist (PCL) [ Time Frame: pre-treatment (baseline), post-treatment (12 weeks) ]
    On the PCL participants first report an autobiographical narrative of a trauma, and subsequently rate symptom frequency (0 [not at all] - 4 [everyday]) and severity (0 [not at all distressing] - 4 [extremely distressing]) for all DSM-V PTSD symptoms within the past week. The PCL will be administered weekly to evaluate the association of PTSD symptoms with anger cognitions (as measured by the DAR) over the course of the group. Total score ranges from 0 to 80, with higher scores reflecting greater impairment.

  3. The Alcohol Use Disorder Identification Test (AUDIT) [ Time Frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks) ]
    The AUDIT contains 10 multiple choice questions about behavior and symptoms related to alcohol consumption. Scale scores range from 0 to 40, with higher scores reflecting greater impairment. Scores over 8 reflect a strong likelihood of hazardous our harmful alcohol consumption.

  4. The Drug Abuse Screening Test (DAST) [ Time Frame: pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233517


Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Elizabeth E Van Voorhees, PhD Durham VA Medical Center, Durham, NC
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Informed Consent Form  [PDF] March 24, 2016


Publications:

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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 Posted: September 8, 2014    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Veterans
Cognitive-Behavioral Therapy
Aggression
Anger
Posttraumatic Stress Disorder
Combat Disorders

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Aggression
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms