Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups (Spouse READI)
20. oktober 2017 opdateret af: Linda O. Nichols, Ph.D., Memphis VA Medical Center
This 12-month study is for spouses or significant others of service members who have returned from Afghanistan or Iraq.
This study will determine if participating in a telephone discussion group, offering education, skills building, and support, will help increase post-deployment adjustment.
There will be 225 spouses recruited for this study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
228
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Tennessee
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Memphis, Tennessee, Forenede Stater, 38104
- Memphis VA Medical Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- have a spouse who participated in a deployment to Iraq and Afghanistan and is at least 1 month post-deployment
- if not married, must have lived as married for at least one year
- must be committed to the relationship
- have a telephone.
Exclusion Criteria:
- known deployment of spouse in the next six months
- auditory impairment that would make telephone use difficult.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Telephone Discussion Groups
Each telephone discussion group will meet 12 times during six months.
The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support.
A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
|
Each telephone discussion group will meet 12 times during six months.
The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support.
A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
|
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Aktiv komparator: Education sessions
Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months.
They will also receive the Participant Workbook.
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Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months.
They will also receive the Participant Workbook.
|
|
Ingen indgriben: Usual Care
Participants do not receive any services.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Spouse Self-report of Anxiety
Tidsramme: Baseline, 6 months, and 12 months
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Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety
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Baseline, 6 months, and 12 months
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Spouse Self-report of Depression
Tidsramme: Baseline, 6 months, and 12 months
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Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression
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Baseline, 6 months, and 12 months
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Spouse Self-report of Resilience
Tidsramme: Baseline, 6 months, and 12 months
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Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience
|
Baseline, 6 months, and 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Linda O Nichols, Ph.D., Memphis VA Medical Center and University of Tennessee Health Science Center
- Ledende efterforsker: Jennifer L Martindale-Adams, Ed.D., University of Tennessee Health Science Center and VA Medical Center Memphis
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Nichols, L.O., Martindale-Adams, J., Zuber, J., Graney, M., Burns, R., & Clark, C. Support for Spouses of Post Deployment Service Members. Military Behavioral Health, Published online: 30 Jan 2015. DOI:10.1080/21635781.2015.1009210
- Nichols L.O., Martindale-Adams, J., Zuber, J., & Graney, M. Service Member Need and Supportive Services Use of Military/Veteran Spouses. Military Behavioral Health, Published online: 09 Feb 2015, DOI:10.1080/21635781.2014.995251
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2009
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
7. maj 2010
Først indsendt, der opfyldte QC-kriterier
11. maj 2010
Først opslået (Skøn)
12. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- W81XWH-09-1-0242
Plan for individuelle deltagerdata (IPD)
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