Effects of RME on Engagement in Buprenorphine Treatment

NCT05184907 | Completed DMC

• 2 other identifiers: CHA-IRB-21-22-29R01CE003039
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (3)

• Number of Self-Reported and Clinic-Reported Opioid Overdose

  12 weeks

• B/N Treatment Retention

  24 weeks

• Brief Addiction Monitor Scale

  12 weeks

Other Outcomes (13)

• Action Plan Initiation: Social Service Engagement

  12 weeks

• Action Plan Initiation: Mental Health Engagement

  12 weeks

• Action Plan Initiation: Wellness/Stress Reduction Engagement

  12 weeks

Study Arms (2)

RME Intervention Arm

EXPERIMENTAL

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).

Behavioral: Remote Motivational Enhancement (RME) Intervention Arm

Information Only Arm

ACTIVE COMPARATOR

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).

Other: Information Only

Interventions

Remote Motivational Enhancement (RME) Intervention Arm BEHAVIORAL

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).

RME Intervention Arm

Information Only OTHER

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).

Information Only Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• University of South Florida: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02141, United States

Location

Related Publications (5)

• 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.

  PMID: 26030317 BACKGROUND

• 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.

  PMID: 32826619 BACKGROUND

• 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.

  PMID: 31264098 BACKGROUND

• 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.

  PMID: 33248863 BACKGROUND

• 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.

  PMID: 11392867 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

• Kathleen Moore, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RME (1-3 sessions) versus information alone

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 11, 2022
• Study Start: May 1, 2022
• Primary Completion: January 11, 2023
• Study Completion: August 2, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)