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Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans (TOTRA)

20. oktober 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

112

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02908
        • Providence VA Medical Center, Providence, RI

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cognitive Behavioral Intervention (CBI)
12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies
Atferdsmessig: Cognitive Behavioral Intervention
Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
Andre navn:
  • CBI
Aktiv komparator: Supportive Intervention (SI)
12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support
Atferdsmessig: Supportive Intervention
Includes individual therapy sessions using supportive and problem-solving strategies.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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
Tidsramme: 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
Tidsramme: 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.
Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

VA Office of Research and Development

Etterforskere

  • Hovedetterforsker: Tracie M. Shea, PhD, Providence VA Medical Center, Providence, RI

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2015

Primær fullføring (Faktiske)

28. februar 2019

Studiet fullført (Faktiske)

28. februar 2019

Datoer for studieregistrering

Først innsendt

6. mai 2014

Først innsendt som oppfylte QC-kriteriene

3. juni 2014

Først lagt ut (Anslag)

6. juni 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • D1146-R
  • Rx 001146 (Annet stipend/finansieringsnummer: VA RR&D)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

I anticipate sharing the data, but have not yet developed a specific plan.

IPD-delingstidsramme

April 1 2021

IPD-deling Støtteinformasjonstype

  • Studieprotokoll
  • Statistisk analyseplan (SAP)
  • Klinisk studierapport (CSR)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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