Trial Outcomes & Findings for Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase (NCT NCT04248933)
NCT ID: NCT04248933
Last Updated: 2022-12-02
Results Overview
Percent of patients retained in MOUD treatment at three months (i.e. still engaged in care) after intervention enrollment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Measured daily from intake to post-treatment (approximately 12-weeks)
Results posted on
2022-12-02
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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37
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Overall Study
Initiated Peer Activate
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32
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Overall Study
Completed Peer Activate Completers (>= 4 Sessions)
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26
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Overall Study
COMPLETED
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26
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Overall Study
NOT COMPLETED
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11
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Lost to Follow-up
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9
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase
Baseline characteristics by cohort
| Measure |
Peer-Delivered Behavioral Activation ("Peer Activate")
n=37 Participants
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.
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|---|---|
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Age, Continuous
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48.81 years
STANDARD_DEVIATION 9.24 • n=99 Participants
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Sex: Female, Male
Female
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16 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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21 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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36 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=99 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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20 Participants
n=99 Participants
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|
Race (NIH/OMB)
White
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11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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37 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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.
Percent of patients retained in MOUD treatment at three months (i.e. still engaged in care) after intervention enrollment.
Outcome measures
| Measure |
Peer-Delivered Behavioral Activation ("Peer Activate")
n=35 Participants
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.
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|---|---|
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MOUD Retention Rate: % of Patients Retained at 3 Months
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31 Participants
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PRIMARY outcome
Timeframe: 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)
Feasibility, defined as the suitability and practicability of the approach, was measured quantitatively as the % of patients who agreed to participate in the intervention.
Outcome measures
| Measure |
Peer-Delivered Behavioral Activation ("Peer Activate")
n=37 Participants
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.
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|---|---|
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Intervention Feasibility: % of Patients Who Agree to Participate in the Intervention
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32 Participants
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SECONDARY outcome
Timeframe: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)Population: Participants who initiated the intervention
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.
Outcome measures
| Measure |
Peer-Delivered Behavioral Activation ("Peer Activate")
n=32 Participants
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.
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|---|---|
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Intervention Acceptability: % of Patients Who Attend ≥75% Sessions
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26 Participants
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Peer-Delivered Behavioral Activation ("Peer Activate")
n=81 intervention session recordings
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.
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Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended
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87.9 Percentage fidelity to treatment
Standard Deviation 18.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Peer-Delivered Behavioral Activation ("Peer Activate")
Serious events: 11 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peer-Delivered Behavioral Activation ("Peer Activate")
n=37 participants at risk
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.
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|---|---|
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Injury, poisoning and procedural complications
Hospitalization
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13.5%
5/37 • Number of events 5 • Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
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Infections and infestations
Hospitalization
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5.4%
2/37 • Number of events 2 • Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
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Psychiatric disorders
Hospitalization
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2.7%
1/37 • Number of events 1 • Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
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Respiratory, thoracic and mediastinal disorders
Hospitalization
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2.7%
1/37 • Number of events 1 • Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
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General disorders
Hospitalization
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5.4%
2/37 • Number of events 2 • Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
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Other adverse events
| Measure |
Peer-Delivered Behavioral Activation ("Peer Activate")
n=37 participants at risk
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.
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|---|---|
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Injury, poisoning and procedural complications
Medical event
|
5.4%
2/37 • Number of events 2 • Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
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Respiratory, thoracic and mediastinal disorders
Medical event
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5.4%
2/37 • Number of events 2 • Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
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General disorders
Medical event
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2.7%
1/37 • Number of events 1 • Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
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Additional Information
Dr. Jessica Magidson
University of Maryland, College Park
Phone: 301-405-5095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place