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Serving Women Using Opioids During Pregnancy (SWOOP)

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ClinicalTrials.gov Identifier: NCT03552120
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Mind and Life Institute, Hadley, Massachusetts
Information provided by (Responsible Party):
Sarah Priddy, University of Utah

Brief Summary:

The purpose of this study is to evaluate the effects of Mindfulness-Oriented Recovery Enhancement (MORE) on opioid misuse and parenting behavior among pregnant women using opioids.

Specific aims are:

AIM 1: To evaluate the preliminary efficacy of MORE, relative to a supportive counseling control condition, on primary outcomes (opioid misuse) and secondary outcomes (opioid craving, psychological distress) among pregnant women using opioids. Hypothesis: Participants who participate in MORE will demonstrate significantly greater improvements than the supportive visit control group on: opioid misuse behaviors, opioid craving, and psychological distress.

AIM 2: To test and quantify the degree to which the impact of MORE on opioid misuse is mediated by changes in cognitive, affective, and autonomic mechanisms relevant to this clinical population - including opioid attentional bias, negative emotion regulation, reward responsiveness, and physiological reactivity to infant cues. Hypothesis: The impact of MORE on craving and opioid misuse behaviors will be mediated by improvements in attentional bias toward opioid cues, negative emotion regulation and natural reward responsiveness on the emotion regulation task, and autonomic reactivity to infant cues.

AIM 3: To evaluate the impact of MORE on mothers' perceptions of their ability to parent effectively and the quality of the mother-baby relationship. Hypothesis: Participants participating in MORE will report more positive beliefs about their ability to effectively parent. Participants who participated in MORE will interact more sensitively with their newborn.

Exploratory AIM 1: To evaluate the efficacy of MORE, relative to a support group control condition, on co-regulation, as measured by an index of sympathetic nervous system functioning, among pregnant women using opioids. Hypothesis 1: Dyads in which the mother participated in MORE will demonstrate significantly greater dyadic synching of sympathetic activity as measured by respiratory sinus arrhythmia (RSA).

Exploratory AIM 2: To test and quantify the degree to which the impact of MORE on dyadic synchrony (during the Still Face Paradigm) is mediated by changes in negative emotion regulation and reward responsiveness. Hypothesis 2: The impact of MORE on dyadic synchrony will be mediated by improvements in negative emotion regulation and natural reward responsiveness as measured by an emotion regulation task.


Condition or disease Intervention/treatment Phase
Opioid Use Pregnancy Related Behavioral: Mindfulness-Oriented Recovery Enhancement Behavioral: Supportive Psychotherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of a Mindfulness-based Intervention on Opioid Use During Pregnancy: A Mixed Methods Pilot RCT
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Experimental: Mindfulness-Oriented Recovery Enhancement Behavioral: Mindfulness-Oriented Recovery Enhancement
MORE is a manualized integrative treatment strategy that targets transdiagnostic mechanisms in stress-related conditions. MORE is made up of three primary components: mindfulness training, cognitive restructuring, and savoring. Mindfulness training aims to increase attentional control to reduce cognitive bias toward negative information. Cognitive reappraisal promotes restructuring of maladaptive cognitions, which would otherwise intensify negative emotion and addictive behavior. Finally, MORE promotes savoring - mindful attention to and appreciation of pleasant events in life as a means of increasing positive emotion regulation.

Active Comparator: Supportive Psychotherapy Behavioral: Supportive Psychotherapy
Supportive psychotherapy is a form of non-directive talk therapy, which follows a Rogerian person-centered approach. The therapist's primary objectives during a session will be (1) to communicate unconditional positive regard for the participant, (2) to communicate engagement and empathic understanding, and (3) to mirror a participant's affect.




Primary Outcome Measures :
  1. Current Opioid Misuse Measure [ Time Frame: Change in COMM score after eight weeks of intervention ]
    The Current Opioid Misuse Measure misuse (COMM; α = .83) is a 17-item scale developed to help physicians identify patients misusing their prescribed opioids. Examples of items include: "In the past 30 days, how often have you needed to take pain medications belonging to someone else?" and, "In the past 30 days, how often have you used your pain medicine for symptoms other than for pain (e.g., to help your sleep, improve your mood, or relieve stress)?"

  2. Brief Child Abuse Potential Inventory [ Time Frame: Change in BCAP score after eight weeks of intervention ]
    The Brief Child Abuse Potential Inventory (B-CAP; α = .89) was developed from the Child Abuse Potential Inventory to identify in a briefer time period individuals at risk for committing child abuse. The B-CAP is a 24-item self-report scale with disagree and agree responses. Items include "Children should never disobey", "Children should be quiet and listen", and "A child needs very strict rules."


Secondary Outcome Measures :
  1. Opioid Craving Visual Analog Scale [ Time Frame: Change in opioid craving visual analog scale score after eight weeks of intervention ]
    Opioid craving will be measured using seven questions with a visual analog scale from 0 to 100 (opioid visual analog scale). Questions include "In the past 24 hours, how strong of an urge did you have to take more opioid medication than prescribed?" and "In the past 24 hours, how often have you found yourself thinking about the next opioid dose?"

  2. Depression, Anxiety and Stress Scale [ Time Frame: Change in DASS score after eight weeks of intervention ]
    Psychological distress will be measured using the composite score of a 21-item Depression, Anxiety, and Stress Scale (DASS-12; α = .93). Some items include "I found myself getting upset by quite trivial things," "I felt I had nothing to look forward to," and "I felt scared without any good reason." Responses range from 0, Did not apply to me at all, to 3, Applied to me very much, or most of the time.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently pregnant
  • Taking opioids (prescription opioids, methadone, suboxone, heroin, kratom, etc.)
  • Fluent in English

Exclusion Criteria:

  • Past experiences with mindfulness-based stress reduction, mindfulness-based relapse prevention, mindfulness-based cognitive therapy
  • Active suicidality
  • Active psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552120


Locations
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United States, Utah
The University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Mind and Life Institute, Hadley, Massachusetts

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Responsible Party: Sarah Priddy, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03552120     History of Changes
Other Study ID Numbers: IRB_00099361
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No