Behavioral Activation, Medication for Opioid Use Disorder (MOUD), Methadone Treatment, Opioid-use Disorder, Peer Delivered, Retention in Care, Substance Use, Substance Use Disorders
Conditions
Keywords
Substance-Related Disorders, Medication Treatment for Opioid Use Disorder, Opioid Crisis, Epidemic, Opioid, Opioid Addiction, Treatment Adherence, Retention in Care
Brief summary
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minoritized individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this pilot trial, the investigators will evaluate the feasibility, acceptability, and fidelity of this approach (implementation outcomes) and preliminary effectiveness on methadone treatment retention at three months.
Detailed description
Opioid use disorder (OUD) disproportionately affects low-income, racial/ethnic minorities (Stahler, 2018). MOUD is efficacious for treating OUD. However, adherence to MOUD is often low, which includes poor treatment retention, especially among low-income, racial/ethnic minority individuals (Stahler, 2018;Williams, 2017). This may be due to barriers such as stigma, challenges navigating services, housing instability, fluctuating motivation and readiness, and other structural and psychosocial factors (Timko, 2016;Carroll, 2015). Peer recovery specialists (PRSs) may be uniquely suited to address these barriers to retention (Jack, 2017;Bassuk, 2016). PRSs are trained individuals who have a personal, lived experience with substance use. Using their lived experience, PRSs can support individuals with OUD to stay retained in care. Rapid increases in the use of PRSs nationwide demonstrate the appeal of employing PRSs as a potentially sustainable solution to support the behavioral treatment needs in OUD care. Yet, few evidence-based interventions have been evaluated for PRS delivery to promote MOUD retention. Prior research has been inconclusive regarding psychosocial interventions to support MOUD retention (Timko, 2016; Carroll, 2017). Reinforcement-based approaches, such as contingency management, have empirical support for improving MOUD retention, but also can have low adoption in community settings due to organizational and provider barriers, including cost in medically underserved areas (Timko, 2016; Carroll, 2017; Carroll, 2015). Successful interventions need to be not only effective in improving MOUD retention, but also be feasible and sustainable to deliver for underserved populations. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD (Magidson, 2011). Originally developed as an efficacious treatment for depression, BA aims to increase positive reinforcement by promoting engagement in adaptive, valued behaviors (Lejuez, 2011). By targeting increases in positive reinforcement, BA has been effective in improving substance use disorder (SUD) treatment retention and preventing future relapse among low-income, minority individuals with SUD. Further, BA has improved medication adherence (i.e., for HIV) among low-income, minority populations with SUD, as well as depression, which may also be a barrier to MOUD retention. Importantly for implementation, BA has previously been implemented in low-resource settings (largely internationally) using lay health workers (e.g., peers, community health workers). However, to date, prior work has yet to evaluate a PRS-delivered BA intervention to support MOUD retention. This study builds upon formative work to adapt and evaluate PRS-delivered BA to support MOUD retention for low-income, minoritized individuals initiating methadone at an outpatient, opioid treatment program in a medically underserved community in Baltimore, Maryland (Magidson, 2011; Magidson, 2018; Satinsky, 2020). The current study has three phases, the first being formative, qualitative work, to adapt the proposed treatment approach. The second phase is a pilot trial (current phase). The pilot trial is an open-label, Type 1 hybrid effectiveness-implementation trial assessing the feasibility, acceptability, and fidelity (implementation outcomes) of a PRS-delivered BA intervention for MOUD retention in methadone treatment, and evaluating retention in the methadone program at three months (primary effectiveness outcome).
Interventions
The Peer Activate intervention consisted of weekly one-hour BA sessions led by a peer recovery specialist (PRS) for up to 12 weekly sessions, with the first five being the core treatment sessions and content, and the subsequent seven designed to reinforce core content. In these sessions, participants received individualized support in learning skills to assist in their retention and persistence in methadone treatment and were guided through exercises aimed at incorporating substance-free, rewarding activities into their daily life.
Sponsors
University of Maryland, Baltimore
National Center for Complementary and Integrative Health (NCCIH)
University of Maryland, College Park
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Initiated methadone at the study site or demonstrated challenges with methadone adherence in the past three months (e.g., at least one indicator of a missed methadone dose) * Minimum of 18 years old
Exclusion criteria
* Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation * Inability to understand the study and provide informed consent in English * Positive pregnancy status at enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MOUD Retention Rate: % of Patients Retained at 3 Months | Measured daily from intake to post-treatment (approximately 12-weeks) | Percent of patients retained in MOUD treatment at three months (i.e. still engaged in care) after intervention enrollment. |
| Intervention Feasibility: % of Patients Who Agree to Participate in the Intervention | Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment) | Feasibility, defined as the suitability and practicability of the approach, was measured quantitatively as the % of patients who agreed to participate in the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability: % of Patients Who Attend ≥75% Sessions | Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment) | Acceptability, defined as satisfaction with or tolerability of the proposed approach, was measured quantitatively by session attendance. Specifically, we measured the % of patients who attended ≥75% of core intervention sessions. |
| Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended | Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment) | Fidelity, defined as the delivery of the intervention as intended, was measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions was rated for fidelity, and we assessed the % of intervention components delivered as intended. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Methadone Use | Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment) | Assessed point prevalence of indicators of methadone use in urinalysis. |
| Change in Depressive Symptoms | Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment) | Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms. |
| Change in Opioid Use | Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment) | Assessed point prevalence of indicators of opioid use in urinalysis. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place at a community-based opioid treatment program (OTP) in Baltimore City between October 2020 and August 2021. The OTP program is certified by the Maryland Department of Health Commission on Accreditation of Rehabilitation Facilities and currently serves approximately six hundred active patients receiving methadone treatment. Participants were recruited through word-of-mouth, flyers left at methadone dosing, on-site recruitment tables (outdoor and indoor), and staff referral.
Participants by arm
| Arm | Count |
|---|---|
| Peer-Delivered Behavioral Activation (Peer Activate) Participants received a peer recovery specialist-delivered behavioral activation (BA) intervention (Peer Activate) to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention.
The Peer Activate intervention consisted of weekly one-hour BA sessions led by a peer recovery specialist (PRS) for up to 12 weekly sessions, with the first five being the core treatment sessions and content, and the subsequent seven designed to reinforce core content. In these sessions, participants received individualized support in learning skills to assist in their retention and persistence in methadone treatment and were guided through exercises aimed at incorporating substance-free, rewarding activities into their daily life. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Peer-Delivered Behavioral Activation (Peer Activate) |
|---|---|
| Age, Continuous | 48.81 years STANDARD_DEVIATION 9.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 5 / 37 |
| serious Total, serious adverse events | 11 / 37 |
Outcome results
Primary
Intervention Feasibility: % of Patients Who Agree to Participate in the Intervention
Feasibility, defined as the suitability and practicability of the approach, was measured quantitatively as the % of patients who agreed to participate in the intervention.
Time frame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Population: Enrolled in the open-label trial (intent-to-treat sample)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer-Delivered Behavioral Activation (Peer Activate) | Intervention Feasibility: % of Patients Who Agree to Participate in the Intervention | 32 Participants |
Primary
MOUD Retention Rate: % of Patients Retained at 3 Months
Percent of patients retained in MOUD treatment at three months (i.e. still engaged in care) after intervention enrollment.
Time frame: Measured daily from intake to post-treatment (approximately 12-weeks)
Population: Verification of methadone retention at the study site and/or outside methadone treatment programs was able to be established for 94.6% of participants (35/37) at monthly intervals (one, two, and three months post-intervention). Two participants were coded as missing, as we were unable to verify their status at an outside treatment program after being transferred.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer-Delivered Behavioral Activation (Peer Activate) | MOUD Retention Rate: % of Patients Retained at 3 Months | 31 Participants |
Secondary
Intervention Acceptability: % of Patients Who Attend ≥75% Sessions
Acceptability, defined as satisfaction with or tolerability of the proposed approach, was measured quantitatively by session attendance. Specifically, we measured the % of patients who attended ≥75% of core intervention sessions.
Time frame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Population: Participants who initiated the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer-Delivered Behavioral Activation (Peer Activate) | Intervention Acceptability: % of Patients Who Attend ≥75% Sessions | 26 Participants |
Secondary
Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended
Fidelity, defined as the delivery of the intervention as intended, was measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions was rated for fidelity, and we assessed the % of intervention components delivered as intended.
Time frame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Population: We selected a random 20% of recorded intervention sessions across individuals who initiated the intervention (n=32), with some additional sessions re-assigned when the originally selected sessions were not completed and additional sessions coded early on in the trial for training purposes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Delivered Behavioral Activation (Peer Activate) | Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended | 87.9 Percentage fidelity to treatment | Standard Deviation 18 |
Other Pre-specified
Change in Depressive Symptoms
Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.
Time frame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Other Pre-specified
Change in Methadone Use
Assessed point prevalence of indicators of methadone use in urinalysis.
Time frame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Other Pre-specified
Change in Opioid Use
Assessed point prevalence of indicators of opioid use in urinalysis.
Time frame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)