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Supporting Treatment Access and Recovery Through Linkage and Support (STAR-LS)

Primary Purpose

Mental Health Disorders, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full MISSION
Linkage Only Delivered by a Peer Specialist
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Disorders focused on measuring Co-Occurring Disorders, Opioid Overdose, Mental Health Disorders, Substance Use, Medication for Opioid Use Disorder (MOUD), Peer Support, Medication Assisted Treatment (MAT), Healthcare Access, Social Determinants of Health, Coordination of Care, Socioecological Model, Multi-component Interventions, Addiction, Equity

Eligibility Criteria

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

Inclusion Criteria: Are 18 or older; Have a COD (1 or more substance use disorders (e.g., alcohol and illicit substances), and a mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia); Are in the Hub; and Are not engaged in other ongoing multi-component treatment for COD with a behavioral health treatment provider or have not seen their provider for at least 3 months. Exclusion Criteria: We will exclude individuals who are acutely psychotic, acutely suicidal with a plan, or homicidal Or with concurrent severe alcohol use disorder or high dose benzodiazepine requiring detoxification.

Sites / Locations

  • University of Massachusetts Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full MISSION

Linkage Only Delivered by a Peer Specialist

Arm Description

Participants assigned to this condition will receive full MISSION services. MISSION services include 6-months of integrated mental health and substance use treatment and treatment planning with the MISSION Case Manager (13 session curriculum) and Peer Support Specialist (11 session curriculum). Content of these sessions will be directed using the MISSION Treatment Manual and Consumer Workbooks. MISSION teams will also provide linkages and supports to treatment services within the participant's community throughout the duration of the study.

Our Linkage only arm delivered by a Peer Specialist will act as the comparison group to the MISSION arm. Participants randomized to the linkage only arm will receive 6-months of linkage care from a Peer Specialist. The Peer Specialist will provide informal treatment planning as well as linkages and support to community services, but will not provide integrated dual disorders treatment, nor will this arm utilize any MISSION materials or offer Peer led groups.

Outcomes

Primary Outcome Measures

Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Baseline Demographics
Self-reported using the Addiction Severity Index (ASI)
Suicide Severity
Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Community Health & Social Needs
Self-report using the Accountable Health Communities & Health-Related Social Needs
Fidelity to Intervention
Measured via clinical staff submitting weekly treatment fidelity logs
Acceptability & Appropriateness
Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)
Feasibility of Intervention
Using the Feasibility of Intervention Measure (FIM)
Satisfaction with Care
Self-report using the Treatment Satisfaction Questionnaire

Secondary Outcome Measures

Full Information

First Posted
January 27, 2023
Last Updated
May 30, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
Centers for Disease Control and Prevention, University of Massachusetts, Lowell, University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT05713695
Brief Title
Supporting Treatment Access and Recovery Through Linkage and Support
Acronym
STAR-LS
Official Title
Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Centers for Disease Control and Prevention, University of Massachusetts, Lowell, University of Massachusetts, Amherst

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
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 (U.S.), with nearly 21 million Americans meeting criteria for substance use disorder (SUD), 1.6 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 U.S. 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 U.S., 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 Prevention's 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 CDC's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorders, Substance Use Disorders
Keywords
Co-Occurring Disorders, Opioid Overdose, Mental Health Disorders, Substance Use, Medication for Opioid Use Disorder (MOUD), Peer Support, Medication Assisted Treatment (MAT), Healthcare Access, Social Determinants of Health, Coordination of Care, Socioecological Model, Multi-component Interventions, Addiction, Equity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices along with MOUD: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full MISSION
Arm Type
Experimental
Arm Description
Participants assigned to this condition will receive full MISSION services. MISSION services include 6-months of integrated mental health and substance use treatment and treatment planning with the MISSION Case Manager (13 session curriculum) and Peer Support Specialist (11 session curriculum). Content of these sessions will be directed using the MISSION Treatment Manual and Consumer Workbooks. MISSION teams will also provide linkages and supports to treatment services within the participant's community throughout the duration of the study.
Arm Title
Linkage Only Delivered by a Peer Specialist
Arm Type
Active Comparator
Arm Description
Our Linkage only arm delivered by a Peer Specialist will act as the comparison group to the MISSION arm. Participants randomized to the linkage only arm will receive 6-months of linkage care from a Peer Specialist. The Peer Specialist will provide informal treatment planning as well as linkages and support to community services, but will not provide integrated dual disorders treatment, nor will this arm utilize any MISSION materials or offer Peer led groups.
Intervention Type
Behavioral
Intervention Name(s)
Full MISSION
Intervention Description
MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery.
Intervention Type
Behavioral
Intervention Name(s)
Linkage Only Delivered by a Peer Specialist
Intervention Description
Linkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services.
Primary Outcome Measure Information:
Title
Self-report opioid use and other substance use
Description
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Time Frame
Baseline
Title
Self-report opioid use and other substance use
Description
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Time Frame
3-months
Title
Self-report opioid use and other substance use
Description
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Time Frame
6-months
Title
Self-report opioid use and other substance use
Description
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Time Frame
9-months
Title
Mental Health Functioning
Description
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Time Frame
Baseline
Title
Mental Health Functioning
Description
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Time Frame
3-months
Title
Mental Health Functioning
Description
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Time Frame
6-months
Title
Mental Health Functioning
Description
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Time Frame
9-months
Title
PTSD Symptoms
Description
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Time Frame
Baseline
Title
PTSD Symptoms
Description
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Time Frame
3-months
Title
PTSD Symptoms
Description
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Time Frame
6-months
Title
PTSD Symptoms
Description
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Time Frame
9-months
Title
Mental Health Impairment
Description
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Time Frame
Baseline
Title
Mental Health Impairment
Description
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Time Frame
3-months
Title
Mental Health Impairment
Description
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Time Frame
6-months
Title
Mental Health Impairment
Description
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Time Frame
9-months
Title
Psychiatric Severity
Description
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time Frame
Screening
Title
Psychiatric Severity
Description
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time Frame
Baseline
Title
Psychiatric Severity
Description
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time Frame
3-months
Title
Psychiatric Severity
Description
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time Frame
6-months
Title
Psychiatric Severity
Description
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time Frame
9-months
Title
Health functioning
Description
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time Frame
Baseline
Title
Health functioning
Description
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time Frame
3-months
Title
Health functioning
Description
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time Frame
6-months
Title
Health functioning
Description
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time Frame
9-months
Title
Therapeutic Alliance Client
Description
Measured by Working Alliance Inventory-C
Time Frame
Baseline
Title
Therapeutic Alliance Client
Description
Measured by Working Alliance Inventory-C
Time Frame
3-months
Title
Therapeutic Alliance Client
Description
Measured by Working Alliance Inventory-C
Time Frame
6-months
Title
Therapeutic Alliance Client
Description
Measured by Working Alliance Inventory-C
Time Frame
9-months
Title
Therapeutic Alliance Therapist
Description
Measured by Working Alliance Inventory-T
Time Frame
Baseline
Title
Therapeutic Alliance Therapist
Description
Measured by Working Alliance Inventory-T
Time Frame
3-months
Title
Therapeutic Alliance Therapist
Description
Measured by Working Alliance Inventory-T
Time Frame
6-months
Title
Therapeutic Alliance Therapist
Description
Measured by Working Alliance Inventory-T
Time Frame
9-months
Title
Recovery Capital
Description
Measured by Assessment of Recovery Capital (ARC)
Time Frame
Baseline
Title
Recovery Capital
Description
Measured by Assessment of Recovery Capital (ARC)
Time Frame
3-months
Title
Recovery Capital
Description
Measured by Assessment of Recovery Capital (ARC)
Time Frame
6-months
Title
Recovery Capital
Description
Measured by Assessment of Recovery Capital (ARC)
Time Frame
9-months
Title
Alcohol or other drug 12-Step Participation
Description
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Time Frame
Baseline
Title
Alcohol or other drug 12-Step Participation
Description
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Time Frame
3-months
Title
Alcohol or other drug 12-Step Participation
Description
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Time Frame
6-months
Title
Alcohol or other drug 12-Step Participation
Description
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Time Frame
9-months
Title
Overdose Risk
Description
Self-report using the Overdose Risk Questionnaire (OdRi)
Time Frame
Baseline
Title
Overdose Risk
Description
Self-report using the Overdose Risk Questionnaire (OdRi)
Time Frame
3-months
Title
Overdose Risk
Description
Self-report using the Overdose Risk Questionnaire (OdRi)
Time Frame
6-months
Title
Overdose Risk
Description
Self-report using the Overdose Risk Questionnaire (OdRi)
Time Frame
9-months
Title
Number of Outreach and Linkage Sessions
Description
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Time Frame
Baseline
Title
Number of Outreach and Linkage Sessions
Description
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Time Frame
3-months
Title
Number of Outreach and Linkage Sessions
Description
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Time Frame
6-months
Title
Number of Outreach and Linkage Sessions
Description
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Time Frame
9-months
Title
Baseline Demographics
Description
Self-reported using the Addiction Severity Index (ASI)
Time Frame
Baseline
Title
Suicide Severity
Description
Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Screening
Title
Community Health & Social Needs
Description
Self-report using the Accountable Health Communities & Health-Related Social Needs
Time Frame
Baseline
Title
Fidelity to Intervention
Description
Measured via clinical staff submitting weekly treatment fidelity logs
Time Frame
Weekly
Title
Acceptability & Appropriateness
Description
Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)
Time Frame
6-months
Title
Feasibility of Intervention
Description
Using the Feasibility of Intervention Measure (FIM)
Time Frame
6-months
Title
Satisfaction with Care
Description
Self-report using the Treatment Satisfaction Questionnaire
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are 18 or older; Have a COD (1 or more substance use disorders (e.g., alcohol and illicit substances), and a mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia); Are in the Hub; and Are not engaged in other ongoing multi-component treatment for COD with a behavioral health treatment provider or have not seen their provider for at least 3 months. Exclusion Criteria: We will exclude individuals who are acutely psychotic, acutely suicidal with a plan, or homicidal Or with concurrent severe alcohol use disorder or high dose benzodiazepine requiring detoxification.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Smelson, PsyD
Phone
508-713-5420
Email
David.Smelson@umassmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paige Shaffer, MPH
Phone
978-609-2312
Email
Paige.Shaffer@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Smelson, PsyD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Smelson, Psy.D.
Email
david.smelson@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Michael Andre, MPH
Email
michael.andre@umassmed.edu
First Name & Middle Initial & Last Name & Degree
David Smelson, Psy.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Consistent with Health and Human Services/Center for Disease Control and Prevention (CDC) policy, research resources and data will be made readily available for research purposes to qualified individuals within the scientific community after publication of any scholarly work. Scholarly publications will also be immediately available to the public on PubMed Central. Additionally, raw and analyzed de-identified data used in publications will be responsibly shared through submissions to a CDC-approved data repository. Other methods for data sharing will be via presentations at professional conferences and, as findings permit, disclosure of summary data to professionals and the general public. To the extent feasible and appropriate, we will share pre-publication findings with colleagues who have a demonstrable, legitimate scientific interest that may be addressed by research findings. We expect to further disseminate the study via gray literature and the project website.
IPD Sharing Time Frame
De-identified data will be shared with qualified and approved researchers via an appropriate data repository. Research data will be destroyed 6 years after the end of the Fiscal Year in which the study is completed. The master list of identifiers will be destroyed at the 6-year mark or when all statistical analyses have been completed and scientific papers have been published, whichever comes first.
IPD Sharing Access Criteria
We will share findings with colleagues who have a demonstrable, legitimate scientific interest that may be addressed by research findings.

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Supporting Treatment Access and Recovery Through Linkage and Support

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