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

May 28, 2024 updated by: Christi Patten, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facebook Intervention
In Phase 3, all participants will receive the same intervention.
Behavioral: Wiidookaage'win Facebook Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
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.
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days since opioid abstinence as assessed by the Timeline Follow-back Interview
Time Frame: 30 days
The participant will be assessed for opioid use each day from the beginning of the intervention to the day before the Interview. Relapse will be operationalized as either a positive opiate UDS or self-report of any illicit opioid use in the past 30 days or since study enrollment.
30 days
MOUD retention as assessed by a Yes/No answer on 30-day follow-up survey
Time Frame: 30 days
The participant will be asked "Do you currently take medication for OUD such as Suboxone, methadone, or naloxone regularly?" on the verbally-administered survey.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Christi Patten, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Actual)

June 8, 2023

Study Completion (Actual)

June 8, 2023

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 16, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-000477
  • UG1DA040316-07S3 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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