Treatment of Chronic Anger and Aggression Following Military-Related Betrayal

NCT06609330 | Recruiting DMC

• 2 other identifiers: 20230329HUW81XWH-22-2-0085
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a treatment designed to deal with anger and aggression from a past betrayal will work. The study will be done on active duty military service members and veterans aged 18 or older. The main questions it aims to answer are:

• Will participants be satisfied with the treatment, and is the treatment feasible to do in a military outpatient setting
• Will the treatment help with anger and aggression issues. Researchers will compare differences in groups that have different wait times (2-, 3-, or 4-weeks). Participants will complete surveys before, during and after the treatment. The treatment will be 14 modules given twice a week. About 1 month after treatment ends, surveys will be taken again.

Conditions

Anger Problems; Aggression

Keywords

Anger management; Military-related betrayal; Deficit of trust

Outcome Measures

Primary Outcomes (5)

• Successful recruitment

  Number of eligible referrals that are recruited, enrolled into the study and randomized to treatment

  Study start to last subject enrolled, approximately 1 year

• Client satisfaction survey (CSQ-8)

  The survey will assess participant acceptability using the CSQ-8, an 8-item self-report measure designed to assess client satisfaction. Each question is answered on a 4-point scale with a possible range of scores between 8-32. A higher score indicates a higher level of overall satisfaction. Mean scores will be used to determine participant satisfaction.

  1 month after study end ( at approximately 11-18 weeks)

• Overt Aggression Scale-Modified (OAS-M)

  A 17-item measure that assesses frequency of different aggression acts in outpatient settings, including verbal and physical aggression against self, other, and objects. The OAS-M is scored by summing the instances of aggression since the last assessment. The OAS-M had been administered as an interview as well as self-report and will be administered as a self-report in this study, consistent with past aggression research with veterans (Miles, Kent et al., 2020). The score is calculated using a sum total of all instances of aggression. Higher scores indicate a greater frequency of aggressive behaviors.

  Baseline to 1 month post treatment (approximately 11-18 weeks)

• Inventory of Interpersonal Problems-Short Version (IIP-32)

  A 32-item self-report assessment designed to measure interpersonal functioning. Items are scored on a five-point scale from 0 (not at all) to 4 (extremely) in response to the stem: "How much have you been distressed by this problem?" There are 8 factors and a total score. The 8 factors are: hard to be assertive, hard to be sociable, hard to be supportive, too dependent, too caring, too aggressive, hard to be involved and too open. The possible total score ranges from a T-score are 0-100. T-scores that are higher than 60 are above average and T-scores 70 or higher suggest significant interpersonal difficulty.

  Baseline to 1 month post treatment (approximately 11-18 weeks)

• State Trait Anger Expression Inventory-2 (STAXI-2)

  A 57-item inventory which measures the frequency and intensity of anger as an emotional state. There are 6 scales, 5 subscales, and an Anger Expression Index (total anger expression). The State Anger scale (15 items) measures anger intensity as a momentary emotional state, while the Trait Anger scale (10 items) measures the disposition to experience angry feelings as a personality-like trait over lengthy time periods (i.e., the individual's disposition to become angry or angry temperament). The Anger Expression scale (16 items) and the Anger Control scale (16 items) measure four anger-related trait dimensions. Ratings of items are on a 4-point response scales that measure state anger (intensity) as well as trait anger (frequency). The possible total range is a T-score from 0 to 100. Individuals with anger scores higher than the 75-percentile experience and/ or express angry feelings to a degree that may interfere with optimal functioning.

  Baseline to 1 month post treatment (approximately 11-18 weeks)

Secondary Outcomes (6)

• Rate of protocol completion

  Treatment end (Approximately 7-14 weeks)

• Number of modules completed

  Baseline to end of treatment (approximately 7-14 weeks)

• Brief Inventory of Psychosocial Functioning (B-IPF)

  Baseline to 1 month post treatment (approximately 11-18 weeks)

• Dimensions of Anger Reactions (DAR-5)

  Baseline to 1 month post treatment (approximately 11-18 weeks)

• Revised Conflict Tactics Scale Short Form (CTS-2)

  Baseline to 1 month post treatment (approximately 11-18 weeks)

Study Arms (3)

2-week wait time group

EXPERIMENTAL

This group is randomized to a 2-week wait time prior to treatment with CART

Behavioral: Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART)

3-week wait time group

EXPERIMENTAL

This group is randomized to a 3-week wait time prior to treatment with CART

Behavioral: Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART)

4-week wait time group

EXPERIMENTAL

This group is randomized to a 4-week wait time prior to treatment with CART

Behavioral: Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART)

Interventions

Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART) BEHAVIORAL

Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART), a novel intervention for reducing chronic anger and aggression and improving interpersonal relationships, in military personnel who have experienced military-related betrayal delivered in 14 treatment modules twice a week.

Also known as: CART

2-week wait time group; 3-week wait time group; 4-week wait time group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult active duty military service members and veterans aged 18 or older.
• Endorses a history of military-related betrayal (on the Modified Moral Injury Questionnaire)
• Endorses problematic anger in the past month (as evidenced by a score of 12 or above on the Dimensions of Anger Reactions; DAR-5)
• Engaged in at least 1 self-reported act of aggression in the past 1 month (on the Overt Aggression Scale-Modified; OAS-M)

You may not qualify if:

• Participated in an anger management or trauma-focused intervention within the past 3 months as assessed by self-report.
• Acute suicidality requiring immediate intervention, such as hospitalization as assessed by the Depressive Symptoms Index-Suicidality Subscale (DSI-SS) combined with follow up clinical interview for elevated scores.
• Is currently homicidal with plans and intent to hurt a specific person and requiring immediate intervention as measured by self-report and follow-up with clinician if screened positive.
• Moderate to severe brain injury as measured by inability to comprehend the informed consent document or baseline assessments.
• Has severe alcohol consumption patterns as evidenced by a score of 19 or above on the Alcohol Use Disorders Identification Test (AUDIT).
• Experiencing active psychosis or mania as measured by the Prodromal Questionnaire-Brief Version and the Mood Disorders Questionnaire.

Sponsors & Collaborators

• United States Department of Defense: collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Carl R. Darnall Army Medical Center (CRDAMC) at Fort Cavazos

Fort Cavazos, Texas, 76554, United States

RECRUITING

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Vanessa Jacoby, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Alan Peterson, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Jacoby, PhD

CONTACT

(254) 289-3468; jacobyv@uthscsa.edu

Alan Peterson, PhD

CONTACT

(210) 562-6700; petersona3@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Upon enrollment into the study, participants will begin with a minimal contact wait condition followed by randomization to different wait times (2-, 3-, or 4-weeks)

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: September 24, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the conclusion of the study and after data are analyzed.
• Access Criteria: Researchers who are interested in IPD should contact STRONG STAR at https://www.strongstar.org/contact/

Locations

US (1)