Opioid UseNCT05340855
A Pilot Study Using Facebook to Support Opioid Recovery Among American Indian Women
A study testing Wiidookaage'win Facebook Group in people with Opioid Use, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Use
- What is being tested?
- Wiidookaage'win Facebook Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2022to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 30Show fewer
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use
- Being tested
- Wiidookaage'win Facebook Group
- Keywords
- American Indian, Alaska Native, Community Based Participatory Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wiidookaage'win Facebook GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Facebook Intervention | Experimental | In Phase 3, all participants will receive the same intervention. Receives: Behavioral: Wiidookaage'win Facebook Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Feasibility of Developing a Culturally Relevant Facebook Intervention
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.
Measured: 30 days
Secondary outcomes (2)
The Feasibility of Using Facebook as an Opioid Intervention Platform
The number of participants who completed all study activities from baseline to end of study.
Measured: 30 days
Treatment Satisfaction
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start5 May 2022
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All study participants in Phase 3 beta test will be in the same Facebook group intervention and will view the same content.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
- Investigators
- Christi Patten, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340855
- Sponsor's protocol ID
- 22-000477
- Other IDs
- UG1DA040316-07S3
- Status last verified
- May 2024
- First submitted
- 7 Apr 2022
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Young A, Sinicrope P, Kelpin S, Roche AI, Sabaque C, Pham C, Marsch LA, Campbell ANC, Venner K, Bastian E, Nord T, Mason G, Baker L, Wyatt T, Fish A, Bart G, Patten CA. Wiidookaage'Win: A Community-Based Qualitative Approach to Developing a Facebook Group Intervention for Native Women to Support Recovery From Opioid Use. Am J Health Promot. 2024 Feb;38(2):205-218. doi: 10.1177/08901171231205355. Epub 2023 Nov 13.
PubMed 37955409
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facebook Intervention for Preventing Opioid Relapse Among American Indian Women: Wiidookaage'Win Pilot Preparatory Study (Aim 1)
- ClinicalTrials.gov ID
- NCT05340855
- Acronym / sponsor ID
- 22-000477
- Conditions
- Opioid Use
- Keywords
- American Indian, Alaska Native, Community Based Participatory Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Posted 20 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study participants in Phase 3 beta test will be in the same Facebook group intervention and will view the same content.
| Arm | Type | Receives |
|---|---|---|
| Facebook Intervention | Experimental | Behavioral: Wiidookaage'win Facebook GroupIn Phase 3, all participants will receive the same intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wiidookaage'win Facebook GroupA 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. | Behavioural | Facebook Intervention |
Primary outcome
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.
2 secondary outcomes
The Feasibility of Using Facebook as an Opioid Intervention Platform
Time frame: 30 days
Treatment Satisfaction
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37955409Young A, Sinicrope P, Kelpin S, Roche AI, Sabaque C, Pham C, Marsch LA, Campbell ANC, Venner K, Bastian E, Nord T, Mason G, Baker L, Wyatt T, Fish A, Bart G, Patten CA. Wiidookaage'Win: A Community-Based Qualitative Approach to Developing a Facebook Group Intervention for Native Women to Support Recovery From Opioid Use. Am J Health Promot. 2024 Feb;38(2):205-218. doi: 10.1177/08901171231205355. Epub 2023 Nov 13.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christi Patten, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wiidookaage'win Facebook Group in people with Opioid Use, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Feasibility of Developing a Culturally Relevant Facebook Intervention (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05340855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.