- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00640445
Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration (M2C)
21. september 2015 oppdatert av: Nina A. Sayer, Minneapolis Veterans Affairs Medical Center
Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration
Veterans returning from combat deployments face the interrelated challenges of processing their combat experiences and transitioning back to civilian life.
Unfortunately, many veterans wait years or decades before seeking help for post-deployment problems, if they seek it at all.
This study seeks to determine whether Internet-Based Expressive Writing (IB-EW), a brief, low-cost, easily disseminated, and resource-efficient intervention, can reduce psychological symptoms and improve functioning among Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans as they navigate this transition, while also attempting to reduce barriers to help-seeking.
Expressive Writing, a highly private, readily accessible, and non-stigmatizing intervention, has a strong evidence-base in civilian populations, but its efficacy in combat veterans has not been tested.
This study therefore seeks to test the efficacy of Expressive Writing in a veteran population while further enhancing its accessibility by delivering it over the internet (Internet-Based Expressive Writing; IB-EW).
This study will comprise a randomized controlled trial with three conditions: (a) Internet-Based Expressive Writing, (b) Internet-Based Control Writing, and (c) No Writing/Treatment As Usual, with a total of 1152 OIF/OEF veterans randomized across these groups.
Expressive Writing participants will write with feeling about their transition from being a soldier to being a civilian; Control Writing participants will write factually about the information needs of new veterans; and Treatment as Usual participants will complete the assessments but not engage in any writing assignments.
Participants will complete standardized self-report measures of psychological symptoms, psychosocial functioning, and life satisfaction at baseline (Session 1) and at three months (Session 6) and six months (Session 7) post-intervention.
Participants in writing conditions will write for 20 minutes on four consecutive days (Sessions 2-5) following completion of baseline measures (participants in the TAU condition will not complete Sessions 2-5).
The study will also attempt to identify individual difference characteristics related to the efficacy of the treatment, to see who may be most likely to benefit from the treatment.
Analyses will primarily entail multivariate analyses of variance.
Power is adequate to detect even a small effect.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1292
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55417
- VA Medical Center
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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
19 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Veteran from current wars in Iraq and Afghanistan
- At least a little difficulty transitioning from soldier to civilian
- Access to computer with internet
- Provide valid contact information
- Available to participate for up to 40 minutes per session
- Interested in participation
- Understand procedures and consent
- Note: participants are recruited by random selection from the target population
Exclusion Criteria:
- Severe depression
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: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Expressive Writing
Participants assigned to the Expressive Writing (EW) condition will write about their deepest thoughts and feelings associated with their experience transitioning from being a soldier to being a civilian for 20 minutes a day for 4 days within a week.
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In EW, people are asked to write about their deepest thoughts and feelings surrounding a significant life event for 20 minutes a day for 4 days
|
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Aktiv komparator: Control Writing
Those assigned to control writing condition will write factually about the information needs of veterans transitioning from active duty to civilian status for 20 minutes on 4 days within one week.
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Those assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.
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Ingen inngripen: No Writing Control
Treatment As Usual
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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PTSD symptoms
Tidsramme: Baseline, 3-month, 6-month
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Baseline, 3-month, 6-month
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Hostility
Tidsramme: Baseline, 3-month, 6-month
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Baseline, 3-month, 6-month
|
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Psychological distress
Tidsramme: Baseline, 3-month, 6-month
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Baseline, 3-month, 6-month
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Physical symptoms
Tidsramme: Baseline, 3-month, 6-month
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Baseline, 3-month, 6-month
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Reintegration difficulty
Tidsramme: Baseline, 3-month, 6-month
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Baseline, 3-month, 6-month
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Social support
Tidsramme: Baseline, 3-month, 6-month
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Baseline, 3-month, 6-month
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Life satisfaction
Tidsramme: Baseline, 3-month, 6-month
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Baseline, 3-month, 6-month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Emotion and causal word use in participants' essays
Tidsramme: Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)
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Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)
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Employment status
Tidsramme: Baseline, 3-month, 6-month
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Baseline, 3-month, 6-month
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Nina A Sayer, PhD, Minneapolis Veterans Affairs Medical Center
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.
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
1. juni 2011
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. september 2013
Datoer for studieregistrering
Først innsendt
18. mars 2008
Først innsendt som oppfylte QC-kriteriene
18. mars 2008
Først lagt ut (Anslag)
21. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. september 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. september 2015
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PT074432
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. .