- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04784663
Offentlige beskeder for at øge behandlingssøgningen for veteraner i risiko for selvmord
Offentlige meddelelser for at øge behandlingssøgningen blandt veteraner i risiko for selvmord under overgangen fra militærtjeneste
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
New York
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Canandaigua, New York, Forenede Stater, 14424-1159
- VA Finger Lakes Healthcare System, Canandaigua, NY
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- amerikansk veteran, der er skilt fra militærtjeneste inden for de seneste 12 måneder (enhver udskrivningstype);
- >18 år gammel;
- oplever selvmordstanker;
- lav hensigt til at søge hjælp;
- i stand til at forstå undersøgelsens mål;
- villig og i stand til at give verbalt samtykke; og 7) ejerskab af smartphone og villig til at downloade/bruge studiemobilapp
Ekskluderingskriterier:
- i øjeblikket (eller inden for de seneste 12 måneder) i formelle behandlingstilbud for mental sundhed;
- anses for svækket under berettigelsesscreening; og 3) i øjeblikket institutionaliseret
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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. |
én push-meddelelse hver uge, hvor man takker enkeltpersoner for deltagelse, informerer dem om, at de vil modtage beskeder i den nærmeste fremtid eller minder dem om undersøgelsens længde.
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. |
én push-meddelelse hver uge, hvor man takker enkeltpersoner for deltagelse, informerer dem om, at de vil modtage beskeder i den nærmeste fremtid eller minder dem om undersøgelsens længde.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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.
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baseline through 2-month follow up
|
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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.
|
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.
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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
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Elizabeth Karras, PhD, VA Finger Lakes Healthcare System, Canandaigua, NY
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SDR 19-354
- HX003130-01A2 (Andet bevillings-/finansieringsnummer: VA Health Services Research & Development)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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