- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157779
Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans (TOTRA)
October 20, 2021 updated by: VA Office of Research and Development
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02908
- Providence VA Medical Center, Providence, RI
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Behavioral Intervention (CBI)
12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies
|
Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
Other Names:
|
Active Comparator: Supportive Intervention (SI)
12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support
|
Includes individual therapy sessions using supportive and problem-solving strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment
|
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.
|
Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
|
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.
|
Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
|
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.
|
Baseline, 12 weeks, 3 and 6 months post-treatment
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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.
|
Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
|
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.
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Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Week 12, 3 and 6 months Post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tracie M. Shea, PhD, Providence VA Medical Center, Providence, RI
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
February 28, 2019
Study Completion (Actual)
February 28, 2019
Study Registration Dates
First Submitted
May 6, 2014
First Submitted That Met QC Criteria
June 3, 2014
First Posted (Estimate)
June 6, 2014
Study Record Updates
Last Update Posted (Actual)
November 18, 2021
Last Update Submitted That Met QC Criteria
October 20, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- D1146-R
- Rx 001146 (Other Grant/Funding Number: VA RR&D)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
I anticipate sharing the data, but have not yet developed a specific plan.
IPD Sharing Time Frame
April 1 2021
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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