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

January 12, 2024 updated by: Sarah Reese, University of Montana

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Missoula, Montana, United States, 59802
        • University of Montana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Oriented Recovery Enhancement via tele-health
Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health.
Behavioral: Mindfulness-Oriented Recovery Enhancement
MORE is a mindfulness-based intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction
Time Frame: 8 weeks
Participants will complete the Client Satisfaction Questionnaire.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUD Symptoms - Mini Neuropsychiatric Interview
Time Frame: 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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Montana

Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Sarah Reese, University of Montana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-21
  • 5P20GM130418 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe