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

Not Applicable

Terminated

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: Mindfulness-Oriented Recovery Enhancement

• Registration Number: NCT04824521
• Lead Sponsor: University of Montana

Brief Summary

Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE.

Detailed Description

Participants will be asked to complete a battery of self-report measures and a semi-structured qualitative interview at three times points-before the intervention begins, after session four, and again after session eight. Participants will also be asked to complete self-report measures before and after each session. The primary aims of this study are as follows.

Aim 1: To adapt the in-person MORE intervention for telehealth delivery. Aim 2: To assess the overall feasibility and acceptability of this telehealth intervention. Hypothesis: MORE delivered via telehealth will be both feasible and acceptable to participants.

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-04-01
• Study Start: 2021-10-01
• Primary Completion: 2022-08-01
• Study Completion: 2023-08-01
• Results First Submitted: 2023-09-18
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Results First Posted: 2024-01-16
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Must be pregnant.
• Must be able to communicate in English.
• Must have met criteria for opioid use disorder in the past year.

Exclusion Criteria

• None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness-Oriented Recovery Enhancement via tele-health	Mindfulness-Oriented Recovery Enhancement	Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health.

Primary Outcome Measures

Name	Time	Method
Client Satisfaction	8 weeks	Participants will complete the Client Satisfaction Questionnaire.

Secondary Outcome Measures

Name	Time	Method
SUD Symptoms - Mini Neuropsychiatric Interview	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.

Trial Locations

Locations (1)

University of Montana; 🇺🇸 Missoula, Montana, United States