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NCT04824521 Clinical Trial

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

Opioid-use Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04824521
Other study ID # 2-21
Secondary ID 5P20GM130418
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date August 1, 2023

Study information
Verified date January 2024
Source University of Montana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date August 1, 2023
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Mindfulness-Oriented Recovery Enhancement
MORE is a mindfulness-based intervention.

Locations
Country Name City State
United States University of Montana Missoula Montana

Sponsors (2)
Lead Sponsor Collaborator
University of Montana National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Client Satisfaction Participants will complete the Client Satisfaction Questionnaire. 8 weeks
Secondary SUD Symptoms - Mini Neuropsychiatric Interview 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
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