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
• 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
• 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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

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