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Completed

NCT Number: NCT05340855

A Pilot Study Using Facebook to Support Opioid Recovery Among American Indian Women

The purpose of this study is to develop a culturally relevant Facebook intervention for American Indian and Alaska Native (AIAN) women in Minnesota recovering from illicit opioid use.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

This one-year, Phase I, pilot preparatory study aims to develop a culturally relevant Facebook intervention for American Indian and Alaska Native (AIAN) women in Minnesota recovering from illicit opioid use. The study will consist of three phases: (1) qualitative interviews, (2) intervention content refinement and a moderator exchange (i.e., bi-directional sharing of knowledge between intervention moderators and trainers), and (3) a beta-testing period. A study-specific Community Advisory Committee (CAC) was formed whose members contributed to the study protocol and will continue to provide guidance and input on the study implementation and dissemination. At the advice of the CAC, a Native Elder woman named the study. Wiidookaage'win is an Ojibwe word that means "the place for help and time for helping," and reflects healing and community. The investigators expect the participatory approach to treatment development will result in a social media intervention with cultural relevance for Native women to maintain recovery from opioid use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Phase 1:

AIAN Women:

  • AIAN based on self-reported race.
  • Gender identity as a woman.
  • Resides in Minnesota.
  • At least 18 years of age age with no upper age limit.
  • OUD based on the DSM-5 Checklist (American Psychiatric Association, 2013).
  • Self-reports at least one month of opioid abstinence based on Timeline Follow-Back (TLFB) interview.
  • Currently receiving MOUD.
  • Is comfortable speaking and reading English.
  • Is familiar with Facebook.
  • Has access to broadband internet on a mobile phone/computer/tablet at any location.

AI/AN Health Care Providers and Stakeholders

  • Health care provider or AIAN community stakeholder.
  • Knowledge of Native culture and/or OUD treatment and recovery among AIAN people.
  • Is comfortable speaking and reading English.
  • Is familiar with Facebook.
  • Has access to broadband internet on a mobile phone/computer/tablet at any location.

Having some familiarity with the Facebook platform is needed to provide feedback on content for a Facebook intervention. Access to the internet is needed to view online moderator postings for providing feedback during the interview.

Inclusion criteria

- Phase 3:

  • AIAN person based on self-reported race/ethnicity.
  • Gender identity as a woman.
  • At least 18 years of age.
  • Resides in Minnesota.
  • 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.
  • Currently receiving 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 one month.
  • 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.

Exclusion criteria

AIAN potential participants in Phases 1 and 3 meeting any of the exclusion criteria listed below will be excluded from study participation. Community stakeholder participants in - Phase 1 will only fail the screening if they meet the second exclusion criterion:

  • Self-reports current suicidality.
  • Inability or unwillingness of participant to provide verbal consent (Phase 1) or written informed consent (Phase 3).
  • (Phase 3 only) Was a participant in Phase 1.

Pregnant women, lactating women, or women who plan to become pregnant will not be excluded because the treatment being evaluated is a behavioral intervention and does not involve medication or risk to the fetus.

Treatment and study plan

Wiidookaage'win Facebook Group

Behavioral

A 30-day Facebook group prototype that is moderated by two women who will post various forms of media addressing opioid recovery, mindfulness, stress management, and resiliency.

Primary outcomes

  1. The Feasibility of Developing a Culturally Relevant Facebook Intervention

    Time frame: 30 days

    The number of times participants engaged with the Facebook page. Define by the total times of viewing, reacting, posting, commenting and voting on any Facebook post for all participants.

Secondary outcomes

  1. The Feasibility of Using Facebook as an Opioid Intervention Platform

    Time frame: 30 days

    The number of participants who completed all study activities from baseline to end of study.

  2. Treatment Satisfaction

    Time frame: 30 days

    Treatment Satisfaction was measured using a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Total scores range from 1 -5. Higher scores indicate greater satisfaction and lower scores indicate lower satisfaction.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Facebook Intervention for Preventing Opioid Relapse Among American Indian Women: Wiidookaage'Win Pilot Preparatory Study (Aim 1)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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