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Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD

3. september 2015 opdateret af: Jason Owen, VA Palo Alto Health Care System

Pilot Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD

The proposed pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder (PTSD). The primary objective of the proposed study is to assess whether family members of veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use. Secondary objectives are to determine if use of the app increases family members' self-efficacy and their ability to manage their own life stress, which may in part be the result of living with someone who has PTSD.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PTSD Family Coach is a mobile phone app for family members of individuals with PTSD. This application provides:

  • education about PTSD
  • a self-assessment tool measuring life stress
  • self-management skills to address acute distress and stress
  • direct connection to support and
  • information about VA and community resources for family members of individuals with PTSD

From this research, the investigators wish to learn whether family members of someone with PTSD find the PTSD Family Coach to be satisfactory and feasible to use. The investigators would also like to know if use of the app increases family members' knowledge of PTSD, and its treatment, and their ability to manage their own life stress, which may in part be the result of living with a Veteran with PTSD.

Currently, there are very few resources for family members of Veterans with PTSD. If this research demonstrates that PTSD Family Coach is a promising tool for family members, it has the potential to address a tremendous unmet need using a very cost-effective, scalable solution.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

242

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Menlo Park, California, Forenede Stater, 94025
        • VA Palo Alto Health Care System

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

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • currently living with a Veteran with significant PTSD symptoms
  • age 18 or older
  • own an iPhone, iPad or other iOS compatible device
  • currently experiencing at least moderate symptoms of stress

Exclusion Criteria:

  • currently enrolled in another study related to PTSD

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: PTSD Family Coach Basic
PTSD Coach basic provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD and additional support resources.
Adfærdsmæssigt: PTSD Family Coach Basic
PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,
Andre navne:
  • PTSD Family Coach app- basic version
Eksperimentel: PTSD Family Coach Full
PTSD Family Coach full provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD, additional support resources, tools for coping with caregiving-related stress, and tools for self-monitoring stress symptoms.
Adfærdsmæssigt: PTSD Family Coach Full
PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information, support resources, tools for coping with caregiver-related stress, and tools for self-monitoring stress symptoms.
Andre navne:
  • PTSD Family Coach app- full version

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Caregiver Burden (Montgomery Burden Interview)
Tidsramme: 1 month
1 month
Stress (Perceived Stress Scale)
Tidsramme: 1 month
1 month
Use of PTSD Family Coach Mobile App (Study-Specific Survey)
Tidsramme: 1 month
1 month
Satisfaction with PTSD Family Coach Mobile App (Study-Specific Survey)
Tidsramme: 1 month
1 month
Depression (PHQ-8)
Tidsramme: 1 month
1 month
Anxiety (GAD)
Tidsramme: 1 month
1 month

Sekundære resultatmål

Resultatmål
Tidsramme
Stigma Associated with Seeking Mental Health Care (Study-Specific Measure)
Tidsramme: 1 month
1 month
Perceived Benefits of Mental Health Treatment for PTSD (Study-Specific Measure)
Tidsramme: 1 month
1 month
Social Constraints (Social Constraints Scale)
Tidsramme: 1 month
1 month
Partner Self-Efficacy (Study-Specific Measure)
Tidsramme: 1 month
1 month
Veteran Interest in Treatment for PTSD (Study-Specific Measure)
Tidsramme: 1 month
1 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA Palo Alto Health Care System

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. januar 2015

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

21. april 2015

Først indsendt, der opfyldte QC-kriterier

26. juni 2015

Først opslået (Skøn)

1. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 28147

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med PTSD Family Coach Basic

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner