NCT05138614

Brief Summary

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2022Aug 2026

First Submitted

Initial submission to the registry

October 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

4.5 years

First QC Date

October 22, 2021

Last Update Submit

June 2, 2025

Conditions

Opioid Use DisorderMental Health Disorder

Keywords

opioid use disordermental health

Outcome Measures

Primary Outcomes (58)

  • Engagement in treatment

    Measured by total days in treatment

    6 months

  • Engagement in medication for opioid use disorder (MOUD)

    Measured by percentage of days receiving MOUD

    6 months

  • Engagement in outreach and linkage sessions

    Measured by total number of outreach and linkage sessions

    6 months

  • Self-report opioid use and other substance use

    Measured by self-report days of use

    Baseline

  • Self-report opioid use and other substance use

    Measured by self-report days of use

    3 months

  • Self-report opioid use and other substance use

    Measured by self-report days of use

    6 months

  • Self-report opioid use and other substance use

    Measured by self-report days of use

    9 months

  • Self-report opioid use and other substance use

    Measured by self-report days of use

    12 months

  • Opioid use and other substance use (drug screen)

    Measured by positive drug screens

    3 months

  • Opioid use and other substance use (drug screen)

    Measured by positive drug screens

    6 months

  • Mental health functioning

    Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)

    Baseline

  • Mental health functioning

    Measured by self-report mental health symptoms on BASIS-24

    3 months

  • Mental health functioning

    Measured by self-report mental health symptoms on BASIS-24

    6 months

  • Mental health functioning

    Measured by self-report mental health symptoms on BASIS-24

    9 months

  • Mental health functioning

    Measured by self-report mental health symptoms on BASIS-24

    12 months

  • PTSD symptoms

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

    Baseline

  • PTSD symptoms

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

    3 months

  • PTSD symptoms

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

    6 months

  • PTSD symptoms

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

    9 months

  • PTSD symptoms

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

    12 months

  • Mental health impairment

    Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)

    Baseline

  • Mental health impairment

    Measured by self-report on WHODAS 2.0

    3 months

  • Mental health impairment

    Measured by self-report on WHODAS 2.0

    6 months

  • Mental health impairment

    Measured by self-report on WHODAS 2.0

    9 months

  • Mental health impairment

    Measured by self-report on WHODAS 2.0

    12 months

  • Psychiatric severity

    Measured by Structured Clinical Interview for DSM-5 (SCID-RV)

    Baseline

  • Health functioning

    Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)

    Baseline

  • Health functioning

    Measured by the WHOQOL-BREF

    3 months

  • Health functioning

    Measured by the WHOQOL-BREF

    6 months

  • Health functioning

    Measured by the WHOQOL-BREF

    9 months

  • Health functioning

    Measured by the WHOQOL-BREF

    12 months

  • Motivation for treatment

    Measured by Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES)

    Baseline

  • Motivation for treatment

    Measured by SOCRATES

    3 months

  • Motivation for treatment

    Measured by SOCRATES

    6 months

  • Motivation for treatment

    Measured by SOCRATES

    9 months

  • Motivation for treatment

    Measured by SOCRATES

    12 months

  • Suicide Severity

    Measured by Columbia- Suicide Severity Rating Scale (C-SSRS)

    Baseline

  • Suicide Severity

    Measured by C-SSRS

    3 months

  • Suicide Severity

    Measured by C-SSRS

    6 months

  • Suicide Severity

    Measured by C-SSRS

    9 months

  • Suicide Severity

    Measured by C-SSRS

    12 months

  • Therapeutic alliance

    Measured by Working Alliance Inventory

    Baseline

  • Therapeutic alliance

    Measured by Working Alliance Inventory

    3 months

  • Therapeutic alliance

    Measured by Working Alliance Inventory

    6 months

  • Therapeutic alliance

    Measured by Working Alliance Inventory

    9 months

  • Therapeutic alliance

    Measured by Working Alliance Inventory

    12 months

  • Recovery Capital

    Measured by Assessment of Recovery Capital

    Baseline

  • Recovery Capital

    Measured by Assessment of Recovery Capital

    3 months

  • Recovery Capital

    Measured by Assessment of Recovery Capital

    6 months

  • Recovery Capital

    Measured by Assessment of Recovery Capital

    9 months

  • Recovery Capital

    Measured by Assessment of Recovery Capital

    12 months

  • Chronic pain

    Measured by Chronic Pain assessment

    Baseline

  • Chronic pain

    Measured by Chronic Pain assessment

    3 months

  • Chronic pain

    Measured by Chronic Pain assessment

    6 months

  • Chronic pain

    Measured by Chronic Pain assessment

    9 months

  • Chronic pain

    Measured by Chronic Pain assessment

    12 months

  • Medication Adherence

    Measured by Medication Adherence Rating Scale

    3 months

  • Medication Adherence

    Measured by Medication Adherence Rating Scale

    6 months

Secondary Outcomes (11)

  • Mortality

    6 months

  • Quality Adjusted Life Years (QALYs): health

    Baseline

  • Quality Adjusted Life Years (QALYs): health

    3 months

  • Quality Adjusted Life Years (QALYs): health

    6 months

  • Quality Adjusted Life Years (QALYs): health

    9 months

  • +6 more secondary outcomes

Other Outcomes (5)

  • Economic impact of full MISSION

    6 months

  • Economic impact of CTI & PS

    6 months

  • Economic impact of CTI & DRT

    6 months

  • +2 more other outcomes

Study Arms (5)

Full MISSION

EXPERIMENTAL

CTI + DRT + PS + MOUD

Other: Medication for Opioid Use DisorderBehavioral: MISSION Critical Time InterventionBehavioral: MISSION Peer SupportBehavioral: MISSION Dual Recovery Therapy

CTI & DRT

EXPERIMENTAL

CTI + DRT + MOUD

Other: Medication for Opioid Use DisorderBehavioral: MISSION Critical Time InterventionBehavioral: MISSION Dual Recovery Therapy

CTI & PS

EXPERIMENTAL

CTI + PS + MOUD

Other: Medication for Opioid Use DisorderBehavioral: MISSION Critical Time InterventionBehavioral: MISSION Peer Support

DRT & PS

EXPERIMENTAL

DRT + PS + MOUD

Other: Medication for Opioid Use DisorderBehavioral: MISSION Peer SupportBehavioral: MISSION Dual Recovery Therapy

MOUD only

OTHER

MOUD

Other: Medication for Opioid Use Disorder

Interventions

Medication for Opioid Use DisorderOTHER

medication management

Also known as: MOUD
CTI & DRTCTI & PSDRT & PSFull MISSIONMOUD only
MISSION Critical Time InterventionBEHAVIORAL

offering intensive community-based services that decrease in intensity over time

Also known as: CTI
CTI & DRTCTI & PSFull MISSION
MISSION Peer SupportBEHAVIORAL

including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders

Also known as: PS
CTI & PSDRT & PSFull MISSION
MISSION Dual Recovery TherapyBEHAVIORAL

comprised of 13 structured co-occurring disorders treatment sessions

Also known as: DRT
CTI & DRTDRT & PSFull MISSION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are 18 years-old and older;
  • Are fluent in English or Spanish;
  • Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been active in the program for the treatment of OUD with medications like buprenorphine or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol, cocaine, opioids, or benzodiazepines). This second group is necessary to include because patients who may have been stable for a long period of time may have a relapse and need intensive treatment to help them regain their abstinence and facilitate the path towards recovery. Thus, by taking those newly enrolled and those who were stable on MOUD but had a recent relapse, the second group is clinically similar to the first group and the intervention will be meaningful.;
  • Able to provide consent;
  • Potentially have a concurrent substance use disorder in addition to opioids; and

You may not qualify if:

  • Are not fluent in English or Spanish;
  • Are acutely psychotic, acutely suicidal with a plan, or homicidal;
  • Are incompetent and unable to provide informed consent; and

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Behavioral Health Network

Holyoke, Massachusetts, 01040, United States

RECRUITING

Behavioral Health Network

Orange, Massachusetts, 01364, United States

RECRUITING

Behavioral Health Network

Springfield, Massachusetts, 01104, United States

RECRUITING

UMass Chan Road to Care Clinic

Worcester, Massachusetts, 01601, United States

RECRUITING

SaVida Health

Worcester, Massachusetts, 01605, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related DisordersMental DisordersPsychological Well-Being

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • David Smelson, PsyD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Smelson, PsyD

CONTACT

508-713-5420David.Smelson@umassmed.edu

Abigail Helm, PhD

CONTACT

413-313-2806Abigail.Helm@umassmed.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2021

First Posted

December 1, 2021

Study Start

March 11, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Consistent with the NIH HEAL Initiative, Underlying Primary Data collected from participants in this project will be made readily available to the public through twice-yearly submissions to the NIMH Data Archive (NDA). In consultation with the University of Massachusetts Medical School's institutional review board (IRB), project consent forms will include relevant information for participants to be made aware that their de-identified data will be available to other investigators as a part of the HEAL Initiative Public Access and Data Sharing Policy.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available upon publication (via an NDA Study) or 1-2 years after the grant end date (August 2026), until 2032 (expiration of NDA Certificate of Confidentiality)
Access Criteria
Data will be shared with authorized NDA users.
More information

Locations

US(5)