- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03199742
Evaluation of a Mobile Phone App for Veterans With PTSD
24. april 2019 opdateret af: Jason Owen, VA Palo Alto Health Care System
The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD.
Participants in this study will be randomized to receive one of 2 possible mobile phone apps.
The term "randomized" means that which app a participant receives will not be based on any characteristic or behavior of the participant, but will be determined solely by chance like a flip of a coin.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants will receive access to the mobile app "PTSD Coach".
Participants will be randomized (by computerized coin flip) to one of two versions of the mobile app.
All versions of the app will provide comprehensive information and tools for managing trauma symptoms, but one version of the app will provide personalized, confidential coaching messages delivered by either a Veteran peer or clinical psychologist.
Participants will be asked to complete an online survey before using the mobile phone application and again 8 weeks later.
Participants will be provided with the option to complete a telephone interview after 8 weeks of using the mobile phone application.
To be eligible, participants must be a U.S. military Veteran, age 18 or older, have received a previous diagnosis of PTSD, and own an iPhone or iPad device.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
101
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Menlo Park, California, Forenede Stater, 94025
- VA Palo Alto Health Care System Menlo Park Division
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- U.S. military Veteran
- age 18 or older
- previously diagnosed with PTSD
- own an iPhone or iPad device
Exclusion Criteria:
- no previous history of PTSD
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: PTSD Coach with no Coaching
Participants will receive the PTSD coach mobile app.
|
Mobile phone application providing extensive information about PTSD and treatment, tools for managing PTSD symptoms, self-monitoring using the PTSD Checklist, and resources for obtaining support.
|
Eksperimentel: PTSD Coach with Peer Coaching
Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer.
|
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study.
Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
|
Eksperimentel: PTSD Coach with Clinician coaching
Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist.
|
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study.
Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
|
Eksperimentel: PTSD Coach with Automated Coaching
Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks.
|
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study.
Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
PTSD Checklist 5
Tidsramme: 8 weeks
|
Measures symptoms of post-traumatic stress disorder
|
8 weeks
|
Functional Well-Being
Tidsramme: 8 weeks
|
Measures functional well-being of Veterans across a number of domains, including self-care, romantic relationships, work, family functioning, and parenting.
Subscale scores will be aggregated to create a summary score for this measure.
|
8 weeks
|
Engagement with the Application
Tidsramme: 8 weeks
|
Objectively-measured engagement with the intervention (# sessions)
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Self-Efficacy for Coping
Tidsramme: 8 weeks
|
Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.
|
8 weeks
|
Perceived Helpfulness of Intervention
Tidsramme: 8 weeks
|
How helpful the intervention was for providing information and tools for managing PTSD.
|
8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
1. juli 2017
Primær færdiggørelse (Faktiske)
1. december 2018
Studieafslutning (Faktiske)
1. marts 2019
Datoer for studieregistrering
Først indsendt
20. juni 2017
Først indsendt, der opfyldte QC-kriterier
23. juni 2017
Først opslået (Faktiske)
27. juni 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-31533
Plan for individuelle deltagerdata (IPD)
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