- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02486705
Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
Pilot Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
California
-
Menlo Park, California, Forente stater, 94025
- VA Palo Alto Health Care System
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,
Andre navn:
|
|
Eksperimentell: 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.
|
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 navn:
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 28147
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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