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Effects of RME on Engagement in Buprenorphine Treatment

Primary Purpose

Opioid Use Disorder, Behavioral Symptoms, Psychiatric or Mood Diseases or Conditions

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Motivational Enhancement (RME) Intervention Arm
Information Only
Sponsored by
Cambridge Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 or older
  • Meets DSM-IV criteria for opioid dependence or DSM-V criteria for opioid use disorder
  • Current patient enrolled in Bicycle Health's buprenorphine treatment program
  • Ability to provide informed consent
  • Access to the internet and an electronic device to attend remote coaching sessions via videoconferencing and complete online assessments
  • Sufficient English fluency to understand study procedures and assessments
  • Completion of the CAT-MH screening modules, BAM, and PSS measures (through CHAMindWell and Bicycle Health's service implementation project)

Exclusion Criteria:

  • Non-English speaking
  • Reporting active homicidal or suicidal ideation
  • Exhibits signs of active mania or psychosis
  • Expected incarceration in next 12 weeks (those that are incarcerated during the study will be withdrawn from the study)
  • Prisoners
  • Unable or unwilling to use a mobile device
  • Has a medical contraindication to BUP
  • Unable to complete screening and baseline assessments
  • Unstable medical illness that could lead to an expected hospitalization in the next 12 weeks
  • Third-trimester pregnancy (if a pregnant participant plans to deliver within 12 weeks of study consent)

Sites / Locations

  • Cambridge Health Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RME Intervention Arm

Information Only Arm

Arm Description

Participants will discuss the results of their CAT-MH, BAM, and PSS with a coach trained in motivational interviewing with 14 days of study randomization. Based on these results, the coach will help to identify behavior change goals, resolve ambivalence, amplify activation, explore their options, and empower the participant toward taking action to obtain appropriate support services tailored to their individual issues and concerns. The number of RME sessions will range from 1-3, determined by the participant's level of activation and desire to engage in additional sessions, as well as the number of challenges identified in their initial session or determined by their CAT-MH results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).

Participants randomized to the information-only arm will have their CAT-MH, BAM, and PSS screening report results sent to their primary B/N prescriber and will encouraged to set up an appointment with their prescriber within 14 days to discuss the results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).

Outcomes

Primary Outcome Measures

Engagement through Action Plan Initiation
1. To examine the effects of RME sessions versus information alone on early engagement in treatment support services as measured by the Action Plan Initiation Survey (APIS-5) with a score of 5-7 representing action plan initiation.

Secondary Outcome Measures

Number of Self-Reported and Clinic-Reported Opioid Overdose
To examine the effect of RME versus information alone on the number of self-reported (with and without naloxone administered) and clinic-reported opioid overdoses throughout the 12 weeks of the study.
B/N Treatment Retention
To examine the effect of RME versus information alone on retention in buprenorphine OUD treatment with an active prescription at 24 weeks as assessed by an active prescription with Bicycle Health in the past 30 days.
Brief Addiction Monitor Scale
To examine the effect of RME versus information alone on change in Brief Addiction Monitor (BAM) subscale scores from 0 to 12 weeks. Drug Use (lower is better outcome) Risk Factors (lower is better outcome) (>12 is considered high risk) Protective Factors (higher is better outcome) (<12 is considered high risk)

Full Information

First Posted
November 24, 2021
Last Updated
March 1, 2023
Sponsor
Cambridge Health Alliance
Collaborators
University of South Florida, Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05184907
Brief Title
Effects of RME on Engagement in Buprenorphine Treatment
Official Title
Effects of Remote Motivational Enhancement on Engagement in Buprenorphine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
University of South Florida, Centers for Disease Control and Prevention

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
The investigators will conduct a Randomized Controlled Trial (RCT) comparing the Remote Motivational Enhancement (RME) coaching sessions + MindWell screenings arm to an Information-only + MindWell screenings arm on early engagement in treatment support services, as measured by overall action plan initiation.
Detailed Description
In an effort to assess and address patients' mental health needs, Cambridge Health Alliance has developed an innovative screening program (MindWell) using electronic computerized adaptive testing that will be used among telemedicine patients with opioid use disorder prescribed buprenorphine by Bicycle Health to evaluate needs related to mental health (CAT-MH) and social determinants of health (CAT-SDOH), as well as for stress (Perceived Stress Scale-PSS) and addiction (Brief Addiction Monitor- BAM). This automated screening with adaptive testing helps to identify those who need social services support (e.g. housing, legal, immigration, financial, food, transportation, etc.) or need further comprehensive mental health evaluation and treatment. Remote Motivational Enhancement (RME) sessions provide telehealth coaching sessions based on motivational interviewing (MI), which is a collaborative, goal-oriented style of communication designed to resolve ambivalence and strengthen intrinsic motivation for a person's commitment to behavior change by eliciting their own reasons for change in an environment of acceptance and compassion. It is an evidence-based and standardized approach that has demonstrated consistently positive clinical outcomes for engagement in wellness, healthcare, and addiction treatment, including effectively improving medical regimen adherence. This study will randomize Bicycle Health patients prescribed Buprenorphine/Naloxone (B/N) who have been screened the MindWell system to receive either standard care reviewing their screening results with their prescriber or they will receive the opportunity to additionally receive up to 3 RME sessions within a 14 day period. This study investigates the effects of the RME intervention on early engagement in psychosocial aspects of B/N telehealth treatment, rates of opioid overdose, and B/N treatment retention. This study will assess the impact of RME sessions on participants' capacity to achieve behavior change goals related to their individual SDOH needs, mental health symptoms, and/or wellness in OUD recovery goals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Behavioral Symptoms, Psychiatric or Mood Diseases or Conditions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RME (1-3 sessions) versus information alone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RME Intervention Arm
Arm Type
Experimental
Arm Description
Participants will discuss the results of their CAT-MH, BAM, and PSS with a coach trained in motivational interviewing with 14 days of study randomization. Based on these results, the coach will help to identify behavior change goals, resolve ambivalence, amplify activation, explore their options, and empower the participant toward taking action to obtain appropriate support services tailored to their individual issues and concerns. The number of RME sessions will range from 1-3, determined by the participant's level of activation and desire to engage in additional sessions, as well as the number of challenges identified in their initial session or determined by their CAT-MH results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).
Arm Title
Information Only Arm
Arm Type
Active Comparator
Arm Description
Participants randomized to the information-only arm will have their CAT-MH, BAM, and PSS screening report results sent to their primary B/N prescriber and will encouraged to set up an appointment with their prescriber within 14 days to discuss the results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).
Intervention Type
Behavioral
Intervention Name(s)
Remote Motivational Enhancement (RME) Intervention Arm
Intervention Description
Participants will discuss the results of their CAT-MH, BAM, and PSS with a coach trained in motivational interviewing within 14 days of study randomization. Based on these results, the coach will help to identify behavior change goals, resolve ambivalence, amplify activation, explore their options, and empower the participant toward taking action to obtain appropriate support services tailored to their individual issues and concerns. The number of RME sessions will range from 1-3, determined by the participant's level of activation and desire to engage in additional sessions, as well as the number of challenges identified in their initial session or determined by their CAT-MH results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).
Intervention Type
Other
Intervention Name(s)
Information Only
Intervention Description
Participants randomized to the information-only arm will have their CAT-MH, BAM, and PSS screening report results sent to their primary B/N prescriber and will encouraged to set up an appointment with their prescriber within 14 days to discuss the results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).
Primary Outcome Measure Information:
Title
Engagement through Action Plan Initiation
Description
1. To examine the effects of RME sessions versus information alone on early engagement in treatment support services as measured by the Action Plan Initiation Survey (APIS-5) with a score of 5-7 representing action plan initiation.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of Self-Reported and Clinic-Reported Opioid Overdose
Description
To examine the effect of RME versus information alone on the number of self-reported (with and without naloxone administered) and clinic-reported opioid overdoses throughout the 12 weeks of the study.
Time Frame
12 weeks
Title
B/N Treatment Retention
Description
To examine the effect of RME versus information alone on retention in buprenorphine OUD treatment with an active prescription at 24 weeks as assessed by an active prescription with Bicycle Health in the past 30 days.
Time Frame
24 weeks
Title
Brief Addiction Monitor Scale
Description
To examine the effect of RME versus information alone on change in Brief Addiction Monitor (BAM) subscale scores from 0 to 12 weeks. Drug Use (lower is better outcome) Risk Factors (lower is better outcome) (>12 is considered high risk) Protective Factors (higher is better outcome) (<12 is considered high risk)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Action Plan Initiation: Social Service Engagement
Description
To examine the effects of RME sessions vs. information alone on early engagement in types of treatment support services as measured by initiation in the social service subtype of treatment engagement. Initiation and engagement of support services for issues related to social determinants of health as measured by action plan initiation self-report at 4 weeks and/or reported appointment with social service professionals within 12 weeks.
Time Frame
12 weeks
Title
Action Plan Initiation: Mental Health Engagement
Description
To examine the effects of RME sessions vs. information alone on early engagement in types of treatment support services as measured by initiation in the mental health subtype of treatment engagement. Self-reported initiation and engagement with mental health services for psychiatric symptoms as measured by action plan initiation self-report at 4 weeks and reported appointment with mental health professionals within 12 weeks.
Time Frame
12 weeks
Title
Action Plan Initiation: Wellness/Stress Reduction Engagement
Description
To examine the effects of RME sessions vs. information alone on early engagement in types of treatment support services as measured by initiation in the wellness/stress reduction subtype of treatment engagement. Self-reported initiation of mental wellness/stress reduction services by action plan initiation self-report at 4 weeks and reported appointment with mental health professionals within 12 weeks.
Time Frame
12 weeks
Title
Changes in Substance Use Risk
Description
To examine a change in CAT-MH-SUD risk scores from 0 to 12 weeks. CAT-MH-SUD is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome).
Time Frame
12 weeks
Title
Changes in Social Vulnerability
Description
To examine a change in CAT-MH-SDOH scores from 0 to 12 weeks. CAT-MH-SDOH is computerized adaptive testing with a normalized score ranging from 0-100 (higher scores are better outcome).
Time Frame
12 weeks
Title
Changes in Anxiety
Description
To examine a change in CAT-MH-Anxiety scores from 0 to 12 weeks. CAT-MH-Anxiety is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome).
Time Frame
12 weeks
Title
Changes in Depression
Description
To examine a change in CAT-MH-Depression scores from 0 to 12 weeks. CAT-MH-Depression is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome).
Time Frame
12 weeks
Title
Changes in Psychosis
Description
To examine a change in CAT-MH-Psychosis scores from 0 to 12 weeks. CAT-MH-Psychosis is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome).
Time Frame
12 weeks
Title
Changes in PTSD symptoms
Description
To examine a change in CAT-MH-PTSD scores from 0 to 12 weeks. CAT-MH-PTSD is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome).
Time Frame
12 weeks
Title
Changes in Mania/Hypomania
Description
To examine a change in CAT-MH-Mania/Hypomania scores from 0 to 12 weeks. CAT-MH-M/HM is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome).
Time Frame
12 weeks
Title
Changes in ADHD symptoms
Description
To examine a change in CAT-MH-ADHD scores from 0 to 12 weeks. CAT-MH-ADHD is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome).
Time Frame
12 weeks
Title
Changes in Level of Intrinsic Motivation
Description
To examine between-group differences in APA-10 scores at weeks 4 and 12 (Higher levels represent increased intrinsic motivation). (Assessing self-efficacy and self-actualization as indicators of intrinsic motivation in accordance with the self-determination theory.)
Time Frame
4 and 12 weeks
Title
Changes in Treatment Services Needed and Received
Description
To examine between-group differences in the change in Treatment Services Needed and Received scores from baseline to week 12 (Each item represents a service that participants indicate needing and/or receiving over the past two weeks. The measure includes separate scales for assessing the need and receipt of medical services (6 items), alcohol / drug services (16 items), psychological / emotional services (18 items), psychiatric crisis services (8 items), and other services (22 items). The amount of unmet service needs is calculated by subtracting the number of services received in each area from the number needed in that respective area.)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 or older Meets DSM-IV criteria for opioid dependence or DSM-V criteria for opioid use disorder Current patient enrolled in Bicycle Health's buprenorphine treatment program Ability to provide informed consent Access to the internet and an electronic device to attend remote coaching sessions via videoconferencing and complete online assessments Sufficient English fluency to understand study procedures and assessments Completion of the CAT-MH screening modules, BAM, and PSS measures (through CHAMindWell and Bicycle Health's service implementation project) Exclusion Criteria: Non-English speaking Reporting active homicidal or suicidal ideation Exhibits signs of active mania or psychosis Expected incarceration in next 12 weeks (those that are incarcerated during the study will be withdrawn from the study) Prisoners Unable or unwilling to use a mobile device Has a medical contraindication to BUP Unable to complete screening and baseline assessments Unstable medical illness that could lead to an expected hospitalization in the next 12 weeks Third-trimester pregnancy (if a pregnant participant plans to deliver within 12 weeks of study consent)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zev Schuman-Olivier, MD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen Moore, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data related to our outcome measures will be included in the IPD sharing plan, in addition to our study protocol, informed consent, and analytic plan.
IPD Sharing Time Frame
After publication and within 12 months of completion of the analysis of study primary aims, anonymous and de-identified data will be made available at the Open Science Framework (http://osf.io/) and/or Harvard Dataverse (https://dataverse.harvard.edu/) so that other investigators can verify or follow-up on the reported analyses.
IPD Sharing Access Criteria
Anonymous and de-identified data will be stored on the Open Science Framework website (http://osf.io/) and/or Harvard Dataverse to be made available to other researchers to verify the research results. Before publication, only USF and CHA investigators will have direct access to the data, and only the CHA HERLab or CHA Center for Mindfulness and Compassion investigators will have access to the analyses.

Learn more about this trial

Effects of RME on Engagement in Buprenorphine Treatment

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