Aggression in Military Personnel (MERA)
Reducing Aggression in Military Personnel: A Randomized Clinical Trial
We propose to study if Manage Emotions to Reduce Aggression (MERA) is helpful in reducing anger and aggression in active duty service members by comparing it to self monitoring of one's anger and aggression. The proposed study has two treatment groups. The first group will receive MERA and then monitor their anger and aggression for 3 more weeks. The second group will be asked to monitor their anger and aggression for 3 weeks prior to receiving MERA. All service members will receive MERA and will be asked to self-monitor, but the order in which they are asked to complete these tasks will be randomized.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Shannon R Miles, PhD
- Telefonní číslo: 106728 8139-972-2000
- E-mail: shannon.miles@va.gov
Studijní záloha kontaktů
- Jméno: Michelle Gaudet
- Telefonní číslo: 813-485-2968
- E-mail: Michelle.Gaudet@va.gov
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Active duty service member 18 years or older.
- Currently meets criteria for full or subthreshold PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R; Jackson et al., 2024) endorsing trauma exposure and a score of > 3 on at least 1 Cluster B, 1 Cluster C, 1 Cluster D, and 1 Cluster E symptom. Symptoms must be present for at least 1 month with clinically significant distress and/or functional impairment (items 23-25 with scores of > 2).
- Engaged in at least 3 self-reported aggressive acts (e.g., yelling, throwing objects, hitting objects/people) in the last month, measured by the 20-item Overt Aggression Scale (OAS; Yudofsky et al., 1986).
- Impulsive aggression is primary form of aggression, determined by the Impulsive Premeditated Aggression Scale (IPAS; Standford et al., 2001).
- Clinically significant anger determined by scores of >12 on the Dimensions of Anger Reactions (DAR-5; Forbes et al., 2014) scale.
Exclusion Criteria:
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Currently suicidal or homicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider.
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Unable to complete self-report measures based on clinical judgement.
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Current manic episode as indicated on the Mood Disorder Questionnaire (MDQ; Hirschfeld et al., 2000) or experiencing psychotic symptoms as indicated on the Prodromal Questionnaire (PQ-16; Ising et al., 2012) requiring immediate stabilization or hospitalization (as determined by clinical assessment and judgment).
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Had a psychotropic medication change within 4 weeks prior to the baseline assessment. Service members receiving general mental health services or engaging in usual care will be allowed to participate.
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Manage Emotions to Reduce Aggression (MERA) X Self-Monitoring
MERA followed by Self-Monitoring. |
Three session treatment that teaches the adaptive value of emotions and emotion regulation skills. Three weeks of tracking anger and aggression and weekly check-ins with study team to assess for risk level. |
|
Aktivní komparátor: Self-Monitoring X Manage Emotions to Reduce Aggression (MERA)
Self-monitoring followed by MERA. |
Three session treatment that teaches the adaptive value of emotions and emotion regulation skills. Three weeks of tracking anger and aggression and weekly check-ins with study team to assess for risk level. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overt Aggression Scale - Modified (OAS-M)
Časové okno: Baseline to 4-week, 8-week, and 20-week post treatment assessments.
|
Overt Aggression Scale (OAS; Yudofsky et al., 1986) is a 16-item self-report measure that assesses frequency of verbal and physical aggression against self, other, and objects. Investigators added 3 items to assess aggression while driving and in virtual communication (e.g. aggression while texting or emailing) and gave a blank for other aggressive behavior. Investigators adapted the instructions to rate aggression over the past week. There are 20 items on the OAS-M. Pilot data demonstrated that this adapted measure is sensitive to detect changes in aggression frequency during the 3 weeks of MERA (Miles, Kent, et al., 2020). Self-reported aggressive acts will be summed to create an OAS total frequency count of aggressive acts at each assessment, with greater scores indicating more acts of aggression in the past week. |
Baseline to 4-week, 8-week, and 20-week post treatment assessments.
|
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State-Trait Anger Expression Inventory-2: State Anger (STAXI-2 S-Anger) Subscale
Časové okno: Baseline to 4-week, 8-week, and 20-week post treatment assessments.
|
State-Trait Anger Expression Inventory-2 Subscale-Anger (STAXI-2 S-Anger; Spielberger, 2010) is a 15-item subscale from the STAXI-2 that measures anger. Investigators adapted the instructions to measure anger in the past week. Items in this subscale ask participants to indicate how much they are experiencing certain feelings and desires on a four-point scale ranging from 1 (not at all) to 4 (very much so). Scores are summed to assess the overall intensity of anger felt in the past week. The total score range is 15-60, with greater scores indicating higher levels of anger. |
Baseline to 4-week, 8-week, and 20-week post treatment assessments.
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Shannon Miles, PhD, James A. Haley Veterans' Hospital
Publikace a užitečné odkazy
Obecné publikace
- Yudofsky SC, Silver JM, Jackson W, Endicott J, Williams D. The Overt Aggression Scale for the objective rating of verbal and physical aggression. Am J Psychiatry. 1986 Jan;143(1):35-9. doi: 10.1176/ajp.143.1.35.
- Spielberger CD. STAXI-2: State-trait anger expression inventory - 2. 1999. Lutz, FL: Psychological Assessment Resources, Inc.
- Miles SR, Kent TA, Stanley M, Thompson KE, Sharp C, Niles BL, Young-McCaughan S, Mintz J, Roache JD, Litz BT, Hale WJ, Stanford MS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Manage Emotions to Reduce Aggression: A Pilot Study of a Brief Treatment to Help Veterans Reduce Impulsive Aggression. J Nerv Ment Dis. 2020 Nov;208(11):897-903. doi: 10.1097/NMD.0000000000001229.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Trauma a poruchy související se stresem
- Aberantní motorické chování u demence
- Duševní poruchy
- Symptomy chování
- Stresové poruchy, traumatické
- Chování
- Společenské chování
- Agrese
- Stresové poruchy, posttraumatické
- Vyšetřovací techniky
- Terapeutika
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Chemická analýza krve
- Testy klinické chemie
- Diagnostické techniky, endokrinní
- Monitorování, fyziologické
- Samoobslužné testování
- Péče o sebe
- Krelodní glukóza samo monitorování
Další identifikační čísla studie
- IRBnet #: 1937626
- HT94252510651 (Jiné číslo grantu/financování: Department of War)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Sharing of the data collected in the conduct of the proposed project will be deposited into the National Institutes of Mental Health (NIMH) Data Archive (NDA) and the UT Health San Antonio Institutional Review Board (IRB)-approved STRONG STAR Repository (HSC2010-475H) for future use.
Časový rámec sdílení IPD
One year after the end of the study.
Kritéria přístupu pro sdílení IPD
Any future research using Repository data will require a research protocol for the proposed study reviewed and approved by an authorized official responsible for protecting human subjects of research. The data protections for privacy and confidentiality described in the consent form will apply to any future use of stored data.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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