- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04784663
Offentlige meldinger for å øke behandlingssøkingen for veteraner i risiko for selvmord
Offentlige meldinger for å øke behandlingssøkingen blant veteraner i risiko for selvmord under overgangen fra militærtjeneste
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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New York
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Canandaigua, New York, Forente stater, 14424-1159
- VA Finger Lakes Healthcare System, Canandaigua, NY
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- amerikansk veteran som har skilt seg fra militærtjeneste i løpet av de siste 12 månedene (enhver utskrivningstype);
- >18 år gammel;
- opplever selvmordstanker;
- lav intensjon om å søke hjelp;
- i stand til å forstå målene for studien;
- villig og i stand til å gi muntlig samtykke; og 7) eierskap av smarttelefon og villig til å laste ned/bruke studiemobilappen
Ekskluderingskriterier:
- for tiden (eller de siste 12 månedene) i formelle behandlingstjenester for psykisk helse;
- anses svekket under kvalifikasjonsscreening; og 3) for tiden institusjonalisert
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Immediate Message Exposure
Participants complete baseline (T1) and are randomly assigned to immediately receive 4 study videos over the first month.
The exposure period ends and participants complete telephone-based assessments at 1- and 2-month follow up (T2 and T3 respectively).
Study videos are delivered by study's mobile app downloaded to participants' own Smartphone.
|
Four brief video messages focused on facilitating treatment seeking.
Intervention delivered to participant by study mobile app downloaded to participants' own smartphone.
|
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Placebo komparator: Wait List Control then message exposure at T2
Participants complete baseline and are randomly assigned to the waitlist control. While wait-listed, participants will receive one push notification each week thanking them for participation, informing them that they will receive messages in the near future or reminding them of the length of the study. Following the 1-month follow up (T2), they receive videos over a one month period. The exposure period ends and participants complete the 2-month follow up (T3) assessment by telephone. Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. |
ett push-varsel hver uke som takker enkeltpersoner for deltakelsen, informerer dem om at de vil motta meldinger i nær fremtid eller minner dem om lengden på studien.
Four brief video messages focused on facilitating treatment seeking.
Intervention delivered to participant by study mobile app downloaded to participants' own smartphone.
|
|
Placebo komparator: Wait List Control then message exposure at T3
Participants complete baseline and are randomly assigned to the waitlist control. While wait-listed, participants will receive one push notification each week thanking them for participation, informing them that they will receive messages in the near future or reminding them of the length of the study. Following completion of the 2 month follow-up (T3), participants receive videos over a one month period. They are not assessed post-exposure. Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. |
ett push-varsel hver uke som takker enkeltpersoner for deltakelsen, informerer dem om at de vil motta meldinger i nær fremtid eller minner dem om lengden på studien.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment Initiation
Tidsramme: baseline through 2-month follow-up
|
yes to initiating psychological treatment and/or medication/pharmacological treatment in the past month to treat mental health issues.
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baseline through 2-month follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Change in Beliefs About Mental Health Treatment
Tidsramme: baseline through 2-month follow up
|
Beliefs about mental health treatment was assessed using the "Perceptions about Services Scale" with individuals endorsing items on a scale from 1 (lowest agreement) to 7 (higher agreement).
A mean is calculated across items to create a composite score (higher score = greater positive beliefs about mental health treatment); lowest score = 1; highest score = 7.
|
baseline through 2-month follow up
|
|
Mean Change in Intentions to Seek Treatment
Tidsramme: baseline through 2-month follow up
|
change in intent to seek mental health treatment in the next month measured using a 7-point likert scale (1 indicating low intent and 7 indicating strong intent) from items in the "Perceptions about Services Scale."
A mean is calculated (higher score representing higher intentions) to create a composite score on the scale.
lowest score = 1; highest score = 7.
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baseline through 2-month follow up
|
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Mean Change in Perceived Treatment Barriers
Tidsramme: baseline through 2-month follow up
|
Used the "Perceived Stigma and Barriers to Care scale" to assess change in agreement with barriers to mental health care that impede one's own behaviors measured using a response scale from 1 (strongly disagree) to 5 (strongly agree).
A mean is calculated across items to create a cumulative score (higher score = more experience with barriers to care).lowest
score = 1; highest score = 5.
|
baseline through 2-month follow up
|
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Mean Change in Normative Beliefs About Seeking Mental Health Care
Tidsramme: baseline through 2-month follow up
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Items assessing subjective norms on seeking mental health care were used from "Perceptions about Services Scale" with scores ranging from 1 (low agreement) to 7 (high agreement).
A mean was calculated to create a cumulative score (higher score = greater positive perceptions about seeking mental health care); 1 = lowest score; 7 = highest score.
|
baseline through 2-month follow up
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Elizabeth Karras, PhD, VA Finger Lakes Healthcare System, Canandaigua, NY
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
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
- SDR 19-354
- HX003130-01A2 (Annet stipend/finansieringsnummer: VA Health Services Research & Development)
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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