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Using Facebook to Support Opioid Recovery Among American Indian Women

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wiidookaage'win Facebook Group
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use Disorder focused on measuring American Indian or Alaska Native, Internet-based Intervention, Community-based Participatory Research, Minnesota, Ethnic and Racial Minorities, Women's Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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

Sites / Locations

  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wiidookaage'win Facebook Group

Online Resources Landing Page

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Timeline Follow-back Interview and UDS to measure Opioid Abstinence
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.
Reporting MOUD continuation
The study team will summarize MOUD continuation as the proportion of participants reporting current use at 6-month follow-up.

Full Information

First Posted
August 1, 2023
Last Updated
October 5, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05995886
Brief Title
Using Facebook to Support Opioid Recovery Among American Indian Women
Official Title
Facebook Intervention for Preventing Opioid Relapse Among American Indian Women: Wiidookaage'Win Pilot Preparatory Study (Aim 2)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
American Indian or Alaska Native, Internet-based Intervention, Community-based Participatory Research, Minnesota, Ethnic and Racial Minorities, Women's Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wiidookaage'win Facebook Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Online Resources Landing Page
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wiidookaage'win Facebook Group
Intervention Description
An online social media group program that incorporates social support, mindfulness-based, and cultural practices that may support OUD recovery.
Primary Outcome Measure Information:
Title
Feasibility of Facebook Intervention
Description
The study team will measure the feasibility from the combined reports of recruitment, study retention, level of Facebook intervention uptake/engagement, and treatment satisfaction.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Timeline Follow-back Interview and UDS to measure Opioid Abstinence
Description
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.
Time Frame
6 months
Title
Reporting MOUD continuation
Description
The study team will summarize MOUD continuation as the proportion of participants reporting current use at 6-month follow-up.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Perceived Stress Scale and Communal Mastery Scale
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants may be cisgender or transgender women. They may also identify as Two Spirit and include "woman" as part of their gender identity.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia M Young, BA
Phone
1-833-880-2600
Email
wiidookaagewin@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christi A Patten, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinna Sabaque
Phone
833-880-2600
Email
Wiidookaagewin@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Using Facebook to Support Opioid Recovery Among American Indian Women

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