NCT05995886

Brief Summary

The purpose of this study is to find out whether a Facebook group will help Native women in recovery from opioid use.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2023Oct 2026

First Submitted

Initial submission to the registry

August 1, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

August 1, 2023

Last Update Submit

May 5, 2026

Conditions

Opioid Use Disorder

Keywords

American Indian or Alaska NativeInternet-based InterventionCommunity-based Participatory ResearchMinnesotaEthnic and Racial MinoritiesWomen's Health

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Facebook Intervention

    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

Secondary Outcomes (2)

  • Timeline Follow-back Interview and UDS to measure Opioid Abstinence

    6 months

  • Reporting MOUD continuation

    6 months

Other Outcomes (1)

  • Perceived Stress Scale and Communal Mastery Scale

    3 months

Study Arms (2)

Wiidookaage'win Facebook Group

EXPERIMENTAL

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.

Behavioral: Wiidookaage'win Facebook Group

Online Resources Landing Page

NO INTERVENTION

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.

Interventions

Wiidookaage'win Facebook GroupBEHAVIORAL

An online social media group program that incorporates social support, mindfulness-based, and cultural practices that may support OUD recovery.

Wiidookaage'win Facebook Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants may be cisgender or transgender women. They may also identify as Two Spirit and include "woman" as part of their gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Christi A Patten, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Brown

CONTACT

1-833-880-2600wiidookaagewin@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 16, 2023

Study Start

October 16, 2023

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

October 25, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)