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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Shannon R Miles, PhD
- Telefonnummer: 106728 8139-972-2000
- E-post: shannon.miles@va.gov
Studer Kontakt Backup
- Navn: Michelle Gaudet
- Telefonnummer: 813-485-2968
- E-post: Michelle.Gaudet@va.gov
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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:
-
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.
-
Unable to complete self-report measures based on clinical judgement.
-
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).
-
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.
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overt Aggression Scale - Modified (OAS-M)
Tidsramme: 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.
|
|
State-Trait Anger Expression Inventory-2: State Anger (STAXI-2 S-Anger) Subscale
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Shannon Miles, PhD, James A. Haley Veterans' Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Traumer og stressorerelaterte lidelser
- Avvikende motorisk oppførsel ved demens
- Psykiske lidelser
- Atferdssymptomer
- Stresslidelser, traumatiske
- Oppførsel
- Sosial oppførsel
- Aggresjon
- Stresslidelser, posttraumatisk
- Undersøkelsesteknikker
- Terapeutikk
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Blodkjemisk analyse
- Kliniske kjemitester
- Diagnostiske teknikker, endokrin
- Overvåking, fysiologisk
- Selvtesting
- Egenomsorg
- Blodsukker selvovervåking
Andre studie-ID-numre
- IRBnet #: 1937626
- HT94252510651 (Annet stipend/finansieringsnummer: Department of War)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
One year after the end of the study.
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .