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Clinical Trials/NCT04824521
NCT04824521
Terminated
Not Applicable

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

University of Montana1 site in 1 country1 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
University of Montana
Enrollment
1
Locations
1
Primary Endpoint
Client Satisfaction
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Reese

Assistant Professor of Social work

University of Montana

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

  • Not provided

Outcomes

Primary Outcomes

Client Satisfaction

Time Frame: 8 weeks

Participants will complete the Client Satisfaction Questionnaire.

Secondary Outcomes

  • SUD Symptoms - Mini Neuropsychiatric Interview(8 weeks)

Study Sites (1)

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