Back to resultsA Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
Primary Purpose
Opioid-use Disorder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Oriented Recovery Enhancement
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
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.
Sites / Locations
- University of Montana
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness-Oriented Recovery Enhancement via tele-health
Arm Description
Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health.
Outcomes
Primary Outcome Measures
Client Satisfaction
Participants will complete the Client Satisfaction Questionnaire.
Secondary Outcome Measures
Symptoms of substance use disorder
Symptoms of substance use disorder will be assessed with the Mini-International Neuropsychiatric Interview 6.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04824521
Brief Title
A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
Official Title
The Mindful Pregnancy Study: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
The protocol is determined to no longer be able to meet study objectives due to failure to enroll participants within the requisite time period.
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Montana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Oriented Recovery Enhancement via tele-health
Arm Type
Experimental
Arm Description
Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Oriented Recovery Enhancement
Intervention Description
MORE is a mindfulness-based intervention.
Primary Outcome Measure Information:
Title
Client Satisfaction
Description
Participants will complete the Client Satisfaction Questionnaire.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Symptoms of substance use disorder
Description
Symptoms of substance use disorder will be assessed with the Mini-International Neuropsychiatric Interview 6.0.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Reese
Organizational Affiliation
University of Montana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Montana
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
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