Evidence map›Paper›PMID 39163904›Full record

ArticleContemporary clinical trials2024

Protocol of a randomized controlled trial examining psychosocial enhancement and standard medication treatment for co-occurring opioid use and mental health disorders: A half fractional factorial randomized controlled trial.

Abigail Helm, Paige Shaffer, Gerardo Gonzalez, Wenjun Li, Todd Olmstead, Daniel Berlowitz, Elizabeth Epstein, David Smelson

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Abigail HelmDepartment of Medicine, Division of Health Systems Science, University of Massachusetts Chan Medical School, Worcester, MA, USA. Electronic address: Abigail.Helm@umassmed.edu.
Paige ShafferDepartment of Medicine, Division of Health Systems Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Gerardo GonzalezMcLean Addiction Treatment Program at Naukeag, Harvard Medical School, Boston, MA, USA.
Wenjun LiDepartment of Public Health, Center for Health Statistics and Biostatistics Core, University of Massachusetts, Lowell, MA, USA.
Todd OlmsteadDepartment of Public & Ecosystem Health, Cornell University, Ithaca, NY, USA.
Daniel BerlowitzDepartment of Public Health, Center for Health Statistics and Biostatistics Core, University of Massachusetts, Lowell, MA, USA.
Elizabeth EpsteinDepartment of Psychiatry, University of Massachusetts Chan Medical School, Worcester, MA, USA.
David SmelsonDepartment of Medicine, Division of Health Systems Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.

Funding

Supporting Treatment Access and Recovery for Co-Occurring Opioid Use and Mental Health Disorders (STAR-COD)R01MH128904 · NIMH · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI GONZALEZ, GERARDO, LI, WENJUN · 2021 to 2024
$12.7M
University of Michigan (UM) HEAL Initiative National K12 Clinical Pain Career Development Program (UM-HCPDP)K12NS130673 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Daniel J Clauw, Steven Edward Harte · 2022 to 2026
$12.5M
NIMH NIH HHS R01 MH128904NINDS NIH HHS K12 NS130673
6 · The paper itself

Abstract

backgroundThe opioid epidemic disproportionately affects individuals with co-occurring opioid use and mental health disorders (COD), who often have poor treatment engagement. Multicomponent treatment models are popular solutions to increase treatment access and engagement for those with COD. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is a hybrid multicomponent linkage and treatment approach that provides assertive community outreach combined with psychosocial treatment. This protocol paper describes a randomized controlled trial comparing MISSION and medication for opioid use disorder (MOUD), its multicomponent parts along with MOUD, and MOUD treatment as usual (TAU) to assess improvements in health and social outcomes.

methodsThis study will use a half fractional factorial design and randomize 1000 patients with COD to one of five treatment conditions: (1) the full MISSION intervention plus MOUD; (2-4) a combination of two out of three MISSION components plus MOUD; or (5) TAU. Secondary aims include examination of mechanisms of action, economic evaluation of the implementation of MISSION and/or its components plus MOUD versus TAU, and exploratory predictive modeling to match optimal MISSION parts with patient needs. DISCUSSION: This randomized controlled trial will help determine the effectiveness of MISSION (or its parts) and MOUD compared to TAU to improve engagement in treatment, substance use, and mental health symptoms. This trial is the first to compare MISSION and its parts with MOUD versus TAU in a real-world treatment scenario to determine which components are necessary and sufficient to drive treatment outcomes according to patient needs.

Indexed as

Mental DisordersOpioid-Related DisordersAdultAnalgesics, OpioidFemaleHumansMaleOpiate Substitution TreatmentPsychosocial InterventionRandomized Controlled Trials as TopicAnalgesics, OpioidCase managementMedication for opioid use disorderMental healthMulticomponent behavioral health interventionsOpioid use disorderPeer support

Identifiers

PMID39163904
PMCPMC11392628

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.