- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05995886
Brug af Facebook til at støtte opioidgendannelse blandt amerikanske indianerkvinder
Facebook-intervention til forebyggelse af opioidtilbagefald blandt amerikanske indiske kvinder: Wiidookaage'Win-pilotforberedende undersøgelse (mål 2)
The purpose of this study is to find out whether a Facebook group will help Native women in recovery from opioid use.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ashley Brown
- Telefonnummer: 1-833-880-2600
- E-mail: wiidookaagewin@mayo.edu
Studiesteder
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55901
- Rekruttering
- Mayo Clinic
-
Kontakt:
- Corinna Sabaque
- Telefonnummer: 833-880-2600
- E-mail: Wiidookaagewin@mayo.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- AIAN person based on self-reported race/ethnicity
- Gender identity as a woman
- At least 18 years of age with no upper age limit
- Resides in Minnesota
- Meets criteria for OUD based on the DSM-5 Checklist (American Psychiatric Association, 2013)
- Self-reports at least one month of abstinence from opioid use based on TLFB interview and negative urine opiate screen
- Current use of MOUD
- Is comfortable speaking and reading English
- Has an existing Facebook account or willing to set one up
- Is willing and able to participate in the Facebook intervention for 3 months
- Has access to broadband internet on a mobile phone/computer/tablet at any location
- Is willing and able to travel to a community clinic in Minneapolis, Minnesota for the UDS or is willing to and able to complete a virtual Zoom UDS visit.
- Provides written informed consent
Exclusion Criteria:
- Self-reports current suicidality based on the Concise Heath Risk Tracking scale
- Participated in prior study phases (Aim 1 formative work) of NIDA CTN-0123
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Wiidookaage'win Facebook Group
The Wiidookaage'win Facebook Group is an online, asynchronous group intervention that will run for 3-months with approximately 30 days of content developed. It is private and hidden, meaning only those in the study will be able to see or find the group. It will be moderated by two women from the study team (one AIAN and one biracial). A back-up moderator will also have access to the group. Participants will be able to comment, react, view, and post in the intervention group, and are encouraged to interact with one another. |
An online social media group program that incorporates social support, mindfulness-based, and cultural practices that may support OUD recovery. |
|
Ingen indgriben: Online Resources Landing Page
The Online Resources Landing Page was developed by the study team using https://carrd.co. It includes links to local programs in family services, substance use recovery, legal advocacy, etc. which already exist and may help support their recovery. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of Facebook Intervention
Tidsramme: 3 months
|
The study team will measure the feasibility from the combined reports of recruitment, study retention, level of Facebook intervention uptake/engagement, and treatment satisfaction. |
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Timeline Follow-back Interview and UDS to measure Opioid Abstinence
Tidsramme: 6 months
|
The study team will explore the preliminary differential impact of the intervention compared with the control condition on opioid abstinence and MOUD continuation. Opioid and other substance use will be assessed through monthly Timeline Follow-Back (TLFB) interviews (Sobell & Sobell, 1992; Wray et al., 2016). At 1, 3, and 6-months, the study team will obtain a UDS that will be used along with the TLFB interviews to measure opioid abstinence. |
6 months
|
|
Reporting MOUD continuation
Tidsramme: 6 months
|
The study team will summarize MOUD continuation as the proportion of participants reporting current use at 6-month follow-up. |
6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived Stress Scale and Communal Mastery Scale
Tidsramme: 3 months
|
The study team will explore the differential impact of the intervention compared with the control condition on constructs targeted by our intervention, specifically perceived stress and coping with stressful life circumstances from a more collectivist orientation, respectively. |
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christi A Patten, PhD, Mayo Clinic
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23-005038
- DA40316-08S2 (Andet bevillings-/finansieringsnummer: National Institute on Drug Abuse)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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