Clinical trial NCT05184907: Effects of RME on Engagement in Buprenorphine Treatment
Official title: Effects of Remote Motivational Enhancement on Engagement in Buprenorphine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Behavioral Symptoms
Psychiatric or Mood Diseases or Conditions
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: Centers for Disease Control and Prevention
First posted: 2022-01-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RME (1-3 sessions) versus information alone
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Engagement through Action Plan Initiation
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Self-Reported and Clinic-Reported Opioid Overdose
timeFrame: 12 weeks
measure: B/N Treatment Retention
timeFrame: 24 weeks
measure: Brief Addiction Monitor Scale
timeFrame: 12 weeks
Other outcomes:
measure: Action Plan Initiation: Social Service Engagement
timeFrame: 12 weeks
measure: Action Plan Initiation: Mental Health Engagement
timeFrame: 12 weeks
measure: Action Plan Initiation: Wellness/Stress Reduction Engagement
timeFrame: 12 weeks
measure: Changes in Substance Use Risk
timeFrame: 12 weeks
measure: Changes in Social Vulnerability
timeFrame: 12 weeks
measure: Changes in Anxiety
timeFrame: 12 weeks
measure: Changes in Depression
timeFrame: 12 weeks
measure: Changes in Psychosis
timeFrame: 12 weeks
measure: Changes in PTSD symptoms
timeFrame: 12 weeks
measure: Changes in Mania/Hypomania
timeFrame: 12 weeks
measure: Changes in ADHD symptoms
timeFrame: 12 weeks
measure: Changes in Level of Intrinsic Motivation
timeFrame: 4 and 12 weeks
measure: Changes in Treatment Services Needed and Received
timeFrame: 12 weeks
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Kathleen Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Achtyes ED, Halstead S, Smart L, Moore T, Frank E, Kupfer DJ, Gibbons R. Validation of Computerized Adaptive Testing in an Outpatient Nonacademic Setting: The VOCATIONS Trial. Psychiatr Serv. 2015 Oct;66(10):1091-6. doi: 10.1176/appi.ps.201400390. Epub 2015 Jun 1.
citation: Drake C, Yu J, Lurie N, Kraemer K, Polsky D, Chaiyachati KH. Policies to Improve Substance Use Disorder Treatment With Telehealth During the COVID-19 Pandemic and Beyond. J Addict Med. 2020 Sep/Oct;14(5):e139-e141. doi: 10.1097/ADM.0000000000000727.
citation: Gibbons RD, deGruy FV. Without Wasting a Word: Extreme Improvements in Efficiency and Accuracy Using Computerized Adaptive Testing for Mental Health Disorders (CAT-MH). Curr Psychiatry Rep. 2019 Jul 1;21(8):67. doi: 10.1007/s11920-019-1053-9.
citation: Langabeer JR 2nd, Yatsco A, Champagne-Langabeer T. Telehealth sustains patient engagement in OUD treatment during COVID-19. J Subst Abuse Treat. 2021 Mar;122:108215. doi: 10.1016/j.jsat.2020.108215. Epub 2020 Nov 24.
citation: Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.