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

NCT ID: NCT04824521

Last Updated: 2024-01-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness-Oriented Recovery Enhancement via tele-health

Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health.

Group Type EXPERIMENTAL

Mindfulness-Oriented Recovery Enhancement

Intervention Type BEHAVIORAL

MORE is a mindfulness-based intervention.

Interventions

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Mindfulness-Oriented Recovery Enhancement

MORE is a mindfulness-based intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Montana

OTHER

Sponsor Role lead

Responsible Party

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Sarah Reese

Assistant Professor of Social work

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Reese

Role: PRINCIPAL_INVESTIGATOR

University of Montana

Locations

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University of Montana

Missoula, Montana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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5P20GM130418

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2-21

Identifier Type: -

Identifier Source: org_study_id

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