Clinical trial NCT06609330: Treatment of Chronic Anger and Aggression Following Military-Related Betrayal
Official title: Assessment and Treatment of Chronic Anger and Aggression Following Military-Related Interpersonal and Institutional Betrayal: A Pilot Investigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anger Problems
Aggression
Keywords: Anger management
Military-related betrayal
Deficit of trust
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Detailed description: Participants will undergo the study procedures described below. The preferred method of assessment and treatment is face-to-face in the STRONG STAR offices at Fort Cavazos. However, there may be circumstances when participants can complete the treatment through telebehavioral health (i.e., by phone or using a HIPAA-compliant video calling platform like Zoom). Decisions will be made on a case-by-case basis as issues arise for individuals (e.g., childcare) and in discussion with the treatment team. If participants do not have internet access they may need to complete assessments in person at the STRONG STAR office or by phone.

* During the wait time:

  * Complete a 5-10 minute assessment twice per week (Monday/Thursday or Tuesday/Friday) to assess level of anger, aggression, and interactions with others since last assessment.
  * The assigned therapist will call participants once a week for a 10-minute, check-in.
  * At the end of participants' assigned wait time, they will complete an assessment of level of anger, aggression, interactions with others, mental, and physical health.
* During treatment:

  * Begin treatment within 1 week of last wait time assessment.
  * Participate in 7-24 (average 14) one-hour bi-weekly (Monday/Thursday or Tuesday/Friday) CART sessions.
  * Prior to each session, participants will complete the same 5-10 minute assessment to assess level of anger, aggression, and interactions with others since last assessment.
  * At the final treatment session, participants will be scheduled to complete a 1-month follow-up assessment.
* For follow-up:

  * Complete a 1-month follow up assessment between 4-8 weeks after the final treatment session.
  * Participants will be sent a link to complete the follow-up assessment.
  * Complete the same questionnaires completed at pre-treatment plus an exit interview and a brief satisfaction survey.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Successful recruitment
timeFrame: Study start to last subject enrolled, approximately 1 year
measure: Client satisfaction survey (CSQ-8)
timeFrame: 1 month after study end ( at approximately 11-18 weeks)
measure: Overt Aggression Scale-Modified (OAS-M)
timeFrame: Baseline to 1 month post treatment (approximately 11-18 weeks)
measure: Inventory of Interpersonal Problems-Short Version (IIP-32)
timeFrame: Baseline to 1 month post treatment (approximately 11-18 weeks)
measure: State Trait Anger Expression Inventory-2 (STAXI-2)
timeFrame: Baseline to 1 month post treatment (approximately 11-18 weeks)
Secondary outcomes:
measure: Rate of protocol completion
timeFrame: Treatment end (Approximately 7-14 weeks)
measure: Number of modules completed
timeFrame: Baseline to end of treatment (approximately 7-14 weeks)
measure: Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: Baseline to 1 month post treatment (approximately 11-18 weeks)
measure: Dimensions of Anger Reactions (DAR-5)
timeFrame: Baseline to 1 month post treatment (approximately 11-18 weeks)
measure: Revised Conflict Tactics Scale Short Form (CTS-2)
timeFrame: Baseline to 1 month post treatment (approximately 11-18 weeks)
measure: Trauma-Related Anger Scale (TRAS)
timeFrame: Baseline to 1 month post treatment (approximately 11-18 weeks)
Other outcomes:
Locations:
city: Fort Cavazos
country: United States
facility: Carl R. Darnall Army Medical Center (CRDAMC) at Fort Cavazos
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Vanessa Jacoby, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Alan Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References: