Mobile Peer Support for OUD Recovery (MPS)
Primary Purpose
Opioid Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Phone App
Sponsored by
About this trial
This is an interventional supportive care trial for Opioid Use Disorder focused on measuring drug overdose, substance-related disorders, chemically-induces disorders, Fentanyl, Analgesics, opioid, Narcotics, Naloxone, Central Nervous System Depressants, Physiological Effects of Drugs, Medications for Opioid Use Disorder, Recovery, Application, Machine-learning, Mobile treatment, Natural language processing, Opioid use disorder, Peer support, Technology
Eligibility Criteria
Inclusion Criteria:
- English-speaking
- Age ≥ 18 years old
- Own their own smartphone
- Self-identifying as being in recovery from or treatment for an opioid use disorder
Exclusion Criteria:
- Does not have an Android or iOS platform smartphone
- Previous enrollment in the study
- Currently incarcerated
- Unable to provide informed consent
Sites / Locations
- Indiana UniversityRecruiting
- Brown University School of Public HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Marigold APP
CONTROL
Arm Description
Participants randomized to receive the APP will be enrolled in an app based peer support program
In the control arm participants will receive existing standardized peer recovery support resources from SAMHSA
Outcomes
Primary Outcome Measures
Change in the Brief Assessment of Recovery Capital (BARC-10) score over 6 month study period
This primary outcome measure will test the efficacy of app-based peer support, compared to the control, in improving recovery capital and engagement in treatment programs. The investigators will measure a change in the Brief Assessment of Recovery Capital (BARC-10) scores, between study groups over 6 months. The Brief Assessment of Recovery Capital will be asked at baseline, 1month follow up, 3 month follow up and 6 month follow up surveys. This score is an abbreviated 10-item measure of recovery capital with high internal consistency. The scale is from 1 "Strongly Disagree" to 6 "Strongly Agree." Total scores can range from 10 to 60. Scores of 47 or higher that are sustained over time indicate higher chances of long term recovery.
Secondary Outcome Measures
Full Information
NCT ID
NCT05405712
First Posted
May 17, 2022
Last Updated
August 17, 2023
Sponsor
Brown University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Indiana University
1. Study Identification
Unique Protocol Identification Number
NCT05405712
Brief Title
Mobile Peer Support for OUD Recovery
Acronym
MPS
Official Title
Increasing Peer Support for OUD Recovery During COVID-19 Through Digital Health: A National Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The COVID-19 pandemic puts individuals recovering from opioid use disorders (OUDs), an already vulnerable population, at increased risk of overdose due to decreased access to treatment, decreased social support, and increased psychosocial stress. This proposal will test the efficacy of a promising mobile app-based peer support program, compared to usual care, in increasing recovery capital, improving retention in treatment, and reducing psychosocial adverse effects, among a national sample of people in recovery from OUD. If effective, it would provide an accessible, personalized, and scalable approach to OUD recovery increasingly needed during the COVID-19 pandemic.
Detailed Description
Increasing numbers of opioid overdoses have been observed during the COVID-19 pandemic, likely reflecting the pandemic's multiple effects on this already vulnerable population. People in recovery from opioid use disorder (OUD) have reported disproportionate psychosocial distress and isolation, as well as significant disruptions in access to treatment including peer support, during the COVID-19 pandemic. These negative outcomes are especially acute for rural, low-income, and minority populations in recovery from OUD. Peer support is a key component of many evidence-based OUD recovery programs: it improves recovery capital, improves treatment engagement, improves perceived social support, and reduces psychosocial distress, particularly when used in conjunction with other evidence-based treatments such as medication for opioid use disorder (MOUD). This grant, submitted in response to PA 20-237, therefore proposes a randomized controlled trial of a novel mobile peer support app platform among a national sample of 1300 patients in recovery from opioid use disorders (OUDs), as an adjunct to usual care, during COVID-19. The previously piloted online-only recruitment and follow-up strategy - in which investigators meld patient-reported outcomes with administrative datasets - allows strategic recruitment of often-excluded participants from across the United States, including those facing the highest barriers to treatment. The mobile app-based peer support intervention, provided as an individual-level enhancement of existing treatment and recovery programs, will allow individuals in OUD recovery to access a tailored, anonymous, peer-moderated support group 24/7. The app is augmented with natural language processing tools capable of automatically 'flagging' critical or clinically relevant content, thereby creating a scalable system to keep groups safe and constructive. Participants will be followed for 6 months through both self-report and administrative outcomes. The study's primary outcome is self-reported recovery capital, complemented by objectively measured administrative data on retention in treatment programs from our community and governmental partners in a sub-sample of 650 patients from RI and IN. Hypothesized secondary outcomes are mitigation of psychosocial effects of COVID-19 on this vulnerable population, including depressive symptoms, stress, and loneliness, as well as objective adverse events of emergency department visits and opioid overdoses. Finally, the investigators will explore whether state- and county-level variables moderate efficacy. OUD is a major public health problem, and patients in recovery from OUD are experiencing worse outcomes during the COVID-19 pandemic. If this mobile app demonstrates efficacy among a large national sample of patients, it has the potential to augment existing treatment programs, improve recovery capital, and reduce disproportionate impacts of COVID-19 on this vulnerable population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
drug overdose, substance-related disorders, chemically-induces disorders, Fentanyl, Analgesics, opioid, Narcotics, Naloxone, Central Nervous System Depressants, Physiological Effects of Drugs, Medications for Opioid Use Disorder, Recovery, Application, Machine-learning, Mobile treatment, Natural language processing, Opioid use disorder, Peer support, Technology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized to receive the APP intervention will receive login and sign up instructions to use the Marigold Health app. Both arms will receive standardized peer recovery support resources from SAMHSA
Masking
InvestigatorOutcomes Assessor
Masking Description
The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments. Additionally, the principal investigator will remain blinded to the randomization.
Allocation
Randomized
Enrollment
1300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Marigold APP
Arm Type
Experimental
Arm Description
Participants randomized to receive the APP will be enrolled in an app based peer support program
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
In the control arm participants will receive existing standardized peer recovery support resources from SAMHSA
Intervention Type
Behavioral
Intervention Name(s)
Mobile Phone App
Other Intervention Name(s)
Peer Recovery App
Intervention Description
App-based peer support program, used in conjunction with standard outpatient treatment
Primary Outcome Measure Information:
Title
Change in the Brief Assessment of Recovery Capital (BARC-10) score over 6 month study period
Description
This primary outcome measure will test the efficacy of app-based peer support, compared to the control, in improving recovery capital and engagement in treatment programs. The investigators will measure a change in the Brief Assessment of Recovery Capital (BARC-10) scores, between study groups over 6 months. The Brief Assessment of Recovery Capital will be asked at baseline, 1month follow up, 3 month follow up and 6 month follow up surveys. This score is an abbreviated 10-item measure of recovery capital with high internal consistency. The scale is from 1 "Strongly Disagree" to 6 "Strongly Agree." Total scores can range from 10 to 60. Scores of 47 or higher that are sustained over time indicate higher chances of long term recovery.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking
Age ≥ 18 years old
Own their own smartphone
Self-identifying as being in recovery from or treatment for an opioid use disorder
Exclusion Criteria:
Does not have an Android or iOS platform smartphone
Previous enrollment in the study
Currently incarcerated
Unable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca L Beaudoin, MD, PhD
Phone
401-863-7200
Email
mps_study@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Peachey, MHA
Email
mps_study@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Ranney, MD, MPH
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Wiehe, MD, MPH
First Name & Middle Initial & Last Name & Degree
Sarah Wiehe, MD, MPH
Facility Name
Brown University School of Public Health
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Beaudoin, MD, PhD
Email
mps_study@brown.edu
First Name & Middle Initial & Last Name & Degree
Megan Ranney, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32149192
Citation
Scherzer CR, Ranney ML, Jain S, Bommaraju SP, Patena J, Langdon K, Nimaja E, Jennings E, Beaudoin FL. Mobile Peer-Support for Opioid Use Disorders: Refinement of an Innovative Machine Learning Tool. J Psychiatr Brain Sci. 2020;5(1):e200001. doi: 10.20900/jpbs.20200001. Epub 2020 Feb 3.
Results Reference
background
Learn more about this trial
Mobile Peer Support for OUD Recovery
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