Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05713695
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-01-27
Brief Title:
Supporting Treatment Access and Recovery Through Linkage and Support
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-LS
Brief Summary:
This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders COD referred from the Worcester Hub This study seeks to evaluate the effectiveness of MISSION a multi-component team approach versus linkage with a Peer Specialist on improving outcomes among individuals with CODs We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement substance use and mental health outcomes This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions
Detailed Description:
Addiction is a growing public health problem in the United States US with nearly 21 million Americans meeting criteria for substance use disorder SUD 16 million meeting criteria for opioid use disorder OUD and opioid-related overdoses have increased by 50 over the past 5 years Among people with SUD 49 have comorbid mental health disorders COD Individuals with COD are vulnerable to substance use relapses mental illness exacerbations overdoses homelessness and criminal justice involvement However despite the high rates of morbidity mortality and broad social determinant of health needs among people with COD only 8 of individuals in the US received treatment for both mental illness and SUD Among those with a COD receiving treatment 6-month engagement rates are as low as 16 for psychosocial treatments and 90 of individuals leaving treatment will relapse within 12 weeks Massachusetts is also hard hit with a 16 higher SUD prevalence compared to the US and Worcester the second largest city in Massachusetts is disproportionately affected by SUD having one of the highest overdose rates in the state and is ranked 2nd on the Center for Disease Control and Preventions social vulnerability index These findings highlight the need to improve treatment access and engagement to support recovery in Worcester Massachusetts Both linkage and multicomponent wraparound models have gained popularity as a solution to increase treatment access and engagement Maintaining Independence and Sobriety through Systems Integration Outreach and Networking MISSION is a hybrid multicomponent linkage and treatment approach providing assertive outreach linkage support combined with psychosocial treatment delivered by a cross disciplinary team MISSION is aligned with the Social Ecological Model SEM to address multilevel client needs via 3 evidence-based practices They include 1 Critical Time Intervention CTI a time-limited form of assertive community treatment 2 Dual Recovery Therapy DRT which is integrated group therapy for COD and 3 Peer Support PS offering support for people in recovery by people in recovery In response to Funding Opportunity Announcement RFA-CE-22-010 the proposed 3-year Hybrid Type I study Supporting Treatment Access and Recovery through Linkage and Support STAR-LS will recruit and randomize 208 patients with COD in Worcester MA in the Hub a program run by the Worcester Health and Human Services to one of the following conditions 1 MISSION or 2 Peer Support linkage only There are three specific aims Aim 1 To evaluate the effectiveness of MISSION or compared to Peer Support to improve engagement substance use and mental health symptoms Aim 2 To examine mechanisms of action of the interventions Aim 3 To conduct a sequential mixed methods process evaluation to inform sustainability and future implementation This proposal is aligned with CDCs Strategic Priority Areas and Health People 2030 Core Objectives as it intends to improve behavioral health outcomes strengthen and sustain the recovery ecosystem for people with COD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None