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

• Sponsor: University of Montana (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04824521
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder	Behavioral: Mindfulness-Oriented Recovery Enhancement	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Mindful Pregnancy Study: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Client Satisfaction [8 weeks]

   Participants will complete the Client Satisfaction Questionnaire.

Secondary Outcome Measures

1. Symptoms of substance use disorder [8 weeks]

   Symptoms of substance use disorder will be assessed with the Mini-International Neuropsychiatric Interview 6.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Montana	Missoula	Montana	United States	59802

Sponsors and Collaborators

• University of Montana

Investigators

• Principal Investigator: Sarah Reese, University of Montana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Reese, Assistant Professor of Social work, University of Montana
• ClinicalTrials.gov Identifier: NCT04824521
• Other Study ID Numbers: 2-21
• First Posted: Apr 1, 2021
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Opioid-Related Disorders; Substance-Related Disorders

Study Results

No Results Posted as of Mar 31, 2022