Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans (TOTRA)

• ClinicalTrials.gov Identifier: NCT02157779
• Recruitment Status: Completed
• First Posted: June 6, 2014
• Results First Posted: March 16, 2020
• Last Update Posted: November 18, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

Excessive and poorly controlled anger is one of the most common problems experienced by war Veterans. The consequences can be severe, including increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Availability of effective treatments is critical to reducing the adverse effects of anger in Veterans. The investigators propose to conduct a controlled study to determine whether a cognitive behavior treatment that has been adapted for treating anger problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a supportive therapy. Results will be examined for improvement in anger, functioning, and quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.

Condition or disease	Intervention/treatment	Phase
Anger Problems	Behavioral: Cognitive Behavioral Intervention; Behavioral: Supportive Intervention	Not Applicable

Detailed Description:

Poorly controlled anger is a common problem with often devastating effects in Veterans who have served in a warzone. Adverse consequences include increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Recent evidence indicates that anger and aggression are likely to be problems for a significant proportion of Veterans of Iraq (Operation Iraqi Freedom, OIF; Operation New Dawn, OND) and Afghanistan (Operation Enduring Freedom, OEF). A survey of reintegration problems among 754 OEF/OIF combat Veterans receiving VA Medical care showed that anger was the most commonly reported problem, with 57% reporting increased problems in controlling anger. Despite encouraging evidence for efficacy of cognitive behavioral interventions in treating anger in civilian samples, much less is known about the efficacy of such treatments for anger problems in military personnel following exposure to war zone trauma. Promising preliminary findings for individually based cognitive behavioral treatment have been reported, and there is evidence that a group anger management treatment delivered by teleconferencing is as effective as the same treatment delivered in person, but to date there is not a single adequately powered randomized trial designed to test the efficacy of an anger treatment compared to an active control condition in Veterans. Building on findings from the investigators' randomized pilot study, the objective of the current proposal is to conduct a randomized clinical trial with sufficient statistical power to test the effectiveness of a manualized cognitive behavioral intervention (CBI) that has been adapted from an existing treatment (Anger Control Therapy; Novaco, 1994, 2001) for the treatment of anger problems in OEF/OIF/OND Veterans, compared to a manualized supportive therapy intervention (SI) control condition. Ninety OEF/OIF/OND Veterans reporting significant problems with anger will be randomized to receive 12 individual sessions of one of the two study conditions. Outcomes including measures of anger and aggression; interpersonal, social and occupational functioning; and quality of life will be assessed during and at the end of treatment and at 3 and 6 month follow-ups. Exploratory analyses will examine 1) whether a diagnosis of PTSD impacts treatment effectiveness and 2) potential mediators of treatment outcome with CBI.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans
• Actual Study Start Date: January 1, 2015
• Actual Primary Completion Date: February 28, 2019
• Actual Study Completion Date: February 28, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cognitive Behavioral Intervention (CBI); 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies	Behavioral: Cognitive Behavioral Intervention; Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management; Other Name: CBI
Active Comparator: Supportive Intervention (SI); 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support	Behavioral: Supportive Intervention; Includes individual therapy sessions using supportive and problem-solving strategies.

Outcome Measures

Primary Outcome Measures :

1. Least Squares Mean Anger Expression Index Score on the State Trait Anger Inventory 2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline and Time Effects [ Time Frame: Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment ]
   The STAXI-2 is a revision of Spielberger's State-Trait Anger Expression Inventory (STAXI), expanded from 44 to 57 items. It is a self-report questionnaire consisting of six scales and an Anger Expression Index (AX). Scales include State Anger, Trait Anger, Anger Expression-Out, Anger Expression-In, Anger Control-Out and Anger Expression-In. The Anger Expression Index is an overall measure of the expression and control of anger based on responses to the two anger expression and the two anger control subscales. Minimum and Maximum Values range from 0 to 96, higher scores mean more anger.
2. Least Squares Mean Aggression Scale Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects [ Time Frame: Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment ]
   Structured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to no maximum, higher scores mean more anger.

Secondary Outcome Measures :

1. Least Squares Mean Global Social Adjustment Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects [ Time Frame: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment ]
   Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation and satisfaction. The global social adjustment score is based upon a 5 point scale. Ratings are based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values range from 1 to 5, higher scores mean worse functioning.
2. Least Squares Mean Global Work Functioning Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects [ Time Frame: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment ]
   Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation, satisfaction and global social adjustment. Ratings are based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values for the work functioning global score range from 1 to 5, higher scores mean worse functioning.
3. Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects [ Time Frame: Baseline, 12 weeks, 3 and 6 months post-treatment ]
   The OQ is a self report measure that assesses functioning and includes three subscales: symptom distress, interpersonal relations, and social role functioning. Concurrent validity has been demonstrated in relation to internal consistency and reliability. Additionally, the OQ has been shown to be fairly stable in untreated individuals and sensitive to change in those individuals in treatment. Minimum and Maximum Values range from 0 to 180, higher scores mean worse functioning.
4. Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects [ Time Frame: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment ]
   The World Health Organization Quality of Life (WHOQOL-BREF), is 26 item self-report measure used to assess quality of life in multiple domains (i.e., physical, psychological, social, and environment). Psychometric properties suggest that the measure is valid and reliable across cultures and nations. Ratings are made on a 5 point scale. The psychological subscale, which consists of 6 items, was used in this study. Minimum and Maximum Values for the psychological domain range from 6 to 30, higher scores mean better quality of life.
5. Least Squares Mean PTSD Severity Score on the Clinician-Administered PTSD Scale (CAPS) for DSM-5 Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects [ Time Frame: Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment ]
   The CAPS-5 (updated for DSM-5) is a clinician administered structured interview for the assessment of DSM-5 PTSD. The CAPS has excellent reliability and validity and is widely used in PTSD treatment research. Each one of the DSM-5 PTSD symptoms is rated on a 0-4 (low to high) scale to determine symptom severity. The cutoff used to establish the presence of an individual symptom is a score of 2 or greater. Overall PTSD severity is computed by summing the totals for all items. Minimum and Maximum Values range from 0 to 80, higher scores mean higher levels of symptomatology.

Other Outcome Measures:

1. Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects [ Time Frame: Baseline, Week 12, 3 and 6 months Post-treatment ]
   The ACQ is a brief self-report measure developed to assess the frequency of negative anger-related behavioral consequences. Internal consistencies of .75 to .91 have been reported. This scale includes items not covered by the other anger measures, including for example, trouble with the law, driving recklessly, getting into an accident, damaging relationships, etc. There are 50 items; minimum and maximum Values range from 0 to 200. Higher scores means more anger.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Male or Female current or former member of the military (active duty, National Guard or Reserve) Deployed to Iraq or Afghanistan
• Experience trauma during deployment
• Clinically significant anger
• At least 2 additional symptoms of PTSD hyperarousal
• If on medication, no changes within prior 4 weeks

Exclusion Criteria:

• Current severe substance use disorder or prior severe substance use disorder not in remission for at least 3 months
• Current psychotic symptoms
• current Mania or Bipolar Disorder
• Current suicidal or homicidal ideation requiring hospitalization
• Any severe cognitive impairment or history of Organic Mental Disorder

Contacts and Locations

Locations

United States, Rhode Island

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States, 02908

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Tracie M. Shea, PhD; Providence VA Medical Center, Providence, RI

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] November 28, 2018

Informed Consent Form  [PDF] September 18, 2017

More Information

Publications:

Shea MT, Lambert J, Reddy MK, Presseau C, Sevin E, Stout RL. Treatment of trauma related anger in operation enduring freedom, operation Iraqi freedom, and operation New Dawn veterans: Rationale and study protocol. Contemp Clin Trials Commun. 2018 Aug 24;12:26-31. doi: 10.1016/j.conctc.2018.08.011. eCollection 2018 Dec. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100688.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02157779
• Other Study ID Numbers: D1146-R; Rx 001146 ( Other Grant/Funding Number: VA RR&D )
• First Posted: June 6, 2014
• Results First Posted: March 16, 2020
• Last Update Posted: November 18, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: I anticipate sharing the data, but have not yet developed a specific plan.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: April 1 2021

• 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; Anger; Cognitive Behavioral Therapy; Treatment