Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder

A Pilot Single Arm Intervention Study of Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder

In this pilot single-armed open-label intervention study of up to 20 individuals with moderate to severe Opioid Use Disorder (OUD)organized into two consecutive groups of up to 10 individuals each, the investigators will measure addiction outcomes and the acceptability and feasibility of adding Mindfulness Oriented Recovery Enhancement (MORE), a promising mind-body therapy to gold standard in-hospital addiction consultation among hospitalized individuals with OUD in advance of a planned two-arm pilot randomized controlled trial.

Study Overview

• Status: Terminated
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: Mindfulness Oriented Recovery Enhancement Sessions

Detailed Description

The investigators will conduct a pilot single-arm intervention study of up to 20 people with moderate to severe OUD. Participants will be enrolled during a hospitalization and receive brief mindfulness training individually in person in the hospital and 8 subsequent sessions of Mindfulness-Oriented Recovery Enhancement (MORE) delivered in small groups of up to 10 people. The intervention will consist of an in-person brief mindfulness training prior to discharge from Massachusetts General Hospital and 8 one-hour group MORE trainings sessions delivered live by a trained addiction social worker over a Zoom telehealth platform.

This study will achieve 2 specific aims. Aim 1 is to quantitatively assess addiction severity, pain, and psychological distress over 12 weeks among people with opioid use disorder receiving manualized Mindfulness-Oriented Recovery Enhancement (MORE) mind-body therapy. Hypothesis 1 is that the receipt of MORE will be associated with decreased addiction severity, pain, and psychological distress among enrolled participants at the end of 12 weeks. Aim 2 is to assess the feasibility and acceptability of conducting a pilot RCT of MORE delivered to people with opioid use disorder and serious bacterial infections. Hypothesis 2 is that more than 50% percent of eligible patients will enroll in the study.

A trained clinical research coordinator (CRC) will attend Addiction Consult Team (ACT) rounds 3 days per week to identify eligible inpatients for this study. Study staff will screen electronic health records (EHR) to confirm eligibility and ask a member of ACT clinical team about the person's suitability to participate given that exclusion criterion may not be known given EHR screening and ACT rounds alone. If the ACT clinician agrees that the participant meets all of the inclusion criteria and none of the exclusion criteria, the ACT clinician will provide the patient with an information sheet about the study. The ACT clinician will then inform the study CRC that the patient has received a brief introduction to the study and is ready to be approached in the hospital using COVID-19 compliant procedures to initiate the consent process.

Prior to receiving the brief mindfulness intervention, enrolled participants will receive and complete a series of quantitative baseline questionnaires (e.g., demographic and substance use history, treatment history) administered by the CRC. These visits will take place in the patient's hospital room (or another private room on the patient's floor in the hospital). At this time, the CRC will also conduct a semi-structured, audio-recorded, qualitative interview with participants. Study outcomes will be assessed in-person at baseline and via mobile phone at 3-, 6-, 9- and 12-week follow-up time points. Upon completion of the intervention and the 12-week follow-up surveys, participants will be asked to complete a 45-60 minute individual exit interview. Informed by an embedded contextual mixed-methods approach, the investigators will also conduct qualitative interviews to better understand why, how, and under what circumstances participants may have achieved reductions in addiction severity in response to MORE.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Division of General Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must be 18 years old and older
• English-speaking
• Hospitalized at Massachusetts General Hospital, being evaluated by the Addiction Consult Team
• Meet DSM-5 criteria for moderate or severe OUD as documented by Addiction Consult Team

Exclusion Criteria:

• Individuals currently admitted to an Intensive Care Unit
• Individuals who are in legal custody or will not be discharged from a controlled environment during the study period
• Inability to provide informed consent as assessed by the medical team
• Active COVID-19 infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindfulness Oriented Recovery Enhancement (MORE) Arm; During hospitalization, participants will receive brief mindfulness training individually in person and complete a series of quantitative baseline questionnaires. Participants will complete 1 MORE session weekly for 8 sessions delivered in small groups of up to 10 people. These sessions will be delivered by a social worker in-person at baseline, and via telehealth after discharge. Follow-up surveys will be conducted at 3-, 6-. 9-, and 12- weeks, and an audio-recorded qualitative exit interview (45-60 minutes) will be completed upon completion of the intervention and the 12-week follow-up survey.

Behavioral: Mindfulness Oriented Recovery Enhancement Sessions; The MORE intervention will involve 8 weekly sessions (approximately 1 hour each), during which participants will be taught how to use mindfulness skills to regulate addiction severity, pain, and stress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Addiction Severity	The Treatment Effectiveness Assessment, a 4 question validated patient-reported outcome measure, will be used to quantitatively assess recovery from addiction	3 months
Enrollment feasibility as measured by the number of individuals who enroll in the study as compared to those who are eligible to enroll	Enrollment percentage as measured by the number of individuals who enroll in the study as compared to those who are eligible to enroll	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress Tolerance	The Distress Tolerance Scale, a 15 item validated patient-reported outcome measure, will be used to quantitatively assess multiple domains of distress tolerance. The scale ranges from 1 ("strongly agree") to 5 ("strongly disagree"). A higher score indicates a better outcome, with only one item being reverse coded.	3 months
Pain Interference	The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference scale, a 6 question validated patient-reported outcome measure, will be used to quantitatively assess pain interference. The scale ranges from 1 ("not at all") to 5 ("very much"). A lower score indicates a better outcome.	3 months
Pain Severity	The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Severity scale, a 3 question validated patient-reported outcome measure, will be used to quantitatively assess pain severity. The scale ranges from 1 ("had no pain") to 5 ("very severe"). A lower score indicates a better outcome.	3 months
Completion of 12-week Follow-up Feasibility	Percentage of those enrolled in the study who complete their 12-week follow-up survey. 100% would be the maximum percentage, and a higher percentage indicates a better outcome.	3 months
Completion of at least 4 MORE sessions feasibility	Percentage of those enrolled in the study who complete at least half the MORE sessions	3 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Benjamin Bearnot, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness; Behavior; Drug Abuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2021P002738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No