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Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims (SBIRT-PTSD)

10. januar 2020 oppdatert av: VA Office of Research and Development

Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims

Veterans can apply for compensation and pension (C & P) benefits for a disability related to military service. The application exam for these benefits provides an opportunity for Veterans returning from service to access VA care. The investigators will recruit Veterans applying for C & P to participate in this study. All enrolled participants will complete questionnaires around the time of their C & P exam related to substance abuse, PTSD, service use, and attitudes. The investigators will monitor enrolled Veterans' attendance at treatment over time, and examine whether C & P award, substance use, and beliefs about benefits are related to treatment attendance. Some enrolled participants will be assigned to one of two study groups: a treatment group and a no-additional-treatment group. People assigned to these groups will complete the same substance abuse, PTSD, service use, and attitudes questionnaires two additional times during the study. Participants assigned to the treatment group will receive information about the relationship between substance use and PTSD and will be referred to relevant treatment. The investigators will test whether Veterans who receive no-additional-treatment have different symptoms over time and attend less treatment sessions (mental health or substance abuse) than people assigned to treatment.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The Compensation examination that determines if a Veteran is entitled to any disability payments related to military service is a crucial gateway to accessing VA care for returning OEF/OIF Veterans. However, researchers and oversight agencies have noted that examiners typically do not have guidelines for evaluating comorbid conditions like substance abuse and for referring patients to treatment.

In the Evaluative Component of this study, OEF/OIF Veterans presenting for Compensation evaluations for PTSD will be approached to undergo a paid battery of confidential substance use, PTSD, service use and attitude assessments prior to their scheduled Compensation examinations. The batteries will be collected again twice, four and twelve weeks after the Compensation examinations. Long-term follow-up data will be extracted from VA databases including diagnoses, the results of the Veterans' Compensation evaluations, award determination, use of VA services and attendance at mental health and/or substance abuse treatment.

In the Clinical Trial Component of this study, one hundred sixty Veterans identified during the baseline evaluation as having a substance use disorder will be randomly assigned to a session of Screening, Brief Intervention and Referral to Treatment (SBIRT) or to No-Additional-Treatment. SBIRT is an approach to identifying and treating patients with substance abuse issues who are presenting for purposes other than substance abuse treatment. It involves Motivational Interviewing, which has been a consistently effective approach to facilitating engagement in substance abuse treatment in Veterans (Davis, Baer et al. 2003) and other populations. The study will examine factors associated with attendance at treatment including substance use, Veterans' beliefs about benefits, and compensation award. Group comparisons will be conducted on rates of treatment attendance, alcohol use, and PTSD symptoms.

Studietype

Intervensjonell

Registrering (Faktiske)

346

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
    • Connecticut
      • West Haven, Connecticut, Forente stater, 06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

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 til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Veteran of OEF or OIF,
  • Not currently receiving VBA Compensation for PTSD,
  • Able to participate psychologically and physically, able to give informed consent and complete, assessments, and participate in study procedures
  • Between the ages of 18-65 years old.

Exclusion Criteria:

  • Will not be able to attend the week 4 or 12 appointment because of anticipated incarceration or move

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: SBIRT

The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver.

Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing.
Atferdsmessig: SBIRT

SBIRT Therapy overview-

  1. Therapist explains purpose of the therapy.
  2. Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.
  3. Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.
  4. Discuss treatment needs, administer screening, provide feedback.
Ingen inngripen: No additional treatment
Veterans assigned to the control condition will not receive any study-related therapy. A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Treatment Attendance by Treatment Group Over Time
Tidsramme: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Mean number of weeks of substance abuse and/or mental health treatment attended (as measured by the Electronic Medical Record) by treatment group over time
4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Substance Use by Treatment Group Over Time
Tidsramme: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Mean days self-reported risky drug or alcohol use
4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Mean PTSD Severity Score
Tidsramme: 12 weeks
Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).
12 weeks

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

Samarbeidspartnere

Yale University

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)

18. mars 2013

Primær fullføring (Faktiske)

30. september 2017

Studiet fullført (Faktiske)

31. desember 2017

Datoer for studieregistrering

Først innsendt

10. mai 2012

Først innsendt som oppfylte QC-kriteriene

11. mai 2012

Først lagt ut (Anslag)

14. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. januar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. januar 2020

Sist bekreftet

1. januar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IIR 11-091

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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

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. .

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