- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05995886
Bruke Facebook for å støtte opioidgjenoppretting blant amerikanske indiske kvinner
Facebook-intervensjon for å forhindre tilbakefall av opioid blant amerikanske indiske kvinner: Wiidookaage'Win-pilotforberedende studie (mål 2)
The purpose of this study is to find out whether a Facebook group will help Native women in recovery from opioid use.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ashley Brown
- Telefonnummer: 1-833-880-2600
- E-post: wiidookaagewin@mayo.edu
Studiesteder
-
-
Minnesota
-
Rochester, Minnesota, Forente stater, 55901
- Rekruttering
- Mayo Clinic
-
Ta kontakt med:
- Corinna Sabaque
- Telefonnummer: 833-880-2600
- E-post: Wiidookaagewin@mayo.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 inngripen: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christi A Patten, PhD, Mayo Clinic
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 23-005038
- DA40316-08S2 (Annet stipend/finansieringsnummer: National Institute on Drug Abuse)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .