Trial Outcomes & Findings for A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder (NCT NCT04824521)

NCT ID: NCT04824521

Last Updated: 2024-01-16

Results Overview

Participants will complete the Client Satisfaction Questionnaire.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2024-01-16

Participant Flow

Study recruitment began 2/10/21 upon IRB approval and ended on 5/1/22. Recruitment efforts included outreach to OBGYN providers, healthcare systems, pain management clinics, substance use treatment providers, community groups, and harm reduction services. Providers and community members were asked to refer potential participants to the study and to post flyers. The team also advertised online through social media.

We did not exclude any participants from the study before assignment to groups.

Participant milestones

Measure	Mindfulness-Oriented Recovery Enhancement Via Tele-health Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. Mindfulness-Oriented Recovery Enhancement: MORE is a mindfulness-based intervention.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Mindfulness-Oriented Recovery Enhancement Via Tele-health Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. Mindfulness-Oriented Recovery Enhancement: MORE is a mindfulness-based intervention.
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder

Baseline characteristics by cohort

Measure	Mindfulness-Oriented Recovery Enhancement Via Tele-health n=1 Participants Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. Mindfulness-Oriented Recovery Enhancement: MORE is a mindfulness-based intervention.
Age, Continuous	31 years n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants
SUD Symptoms - Mini Neuropsychiatric Interview - Alcohol Use Disorder	12 symptoms n=93 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Participant did not complete this measure.

Participants will complete the Client Satisfaction Questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

The Mini Neuropsychiatric Interview is a brief structured diagnostic interview for the major psychiatric disorders in the DSM-V. For this study, we conducted a structured interview with participants to determine the number of symptoms of substance use disorder they had experienced in the past year. After completing eight sessions of Mindfulness-Oriented Recovery Enhancement, we conducted the same interview to learn the number of symptoms of substance use disorder participants had experienced in the past eight weeks.

Outcome measures

Measure	Mindfulness-Oriented Recovery Enhancement Via Tele-health n=1 Participants Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. Mindfulness-Oriented Recovery Enhancement: MORE is a mindfulness-based intervention.
SUD Symptoms - Mini Neuropsychiatric Interview	12 symptoms

Adverse Events

Mindfulness-Oriented Recovery Enhancement Via Tele-health

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Reese

University of Montana

Phone: 7313940288

Email: Sarah.reese@mso.umt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place